Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT01092182
Collaborator
(none)
194
Enrollment
30
Locations
3
Arms
155.2
Anticipated Duration (Months)
6.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:
  • Burkitt lymphoma/leukemia (BL) is highly treatable, but most of the standard therapies require multiple doses of intensive chemotherapy that may require long hospital stays and frequently have severe side effects. In addition, BL is a fairly common type of cancer in patients who also have human immunodeficiency virus (HIV), but treatment outcomes are poor because standard treatments do not work very well in HIV-positive patients and the more intense treatment regimens are highly toxic. New approaches are needed that expand the ways to treat BL with the same efficiency but with reduced side effects.

  • Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) is a standard chemotherapy treatment that consists of the drugs etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. It may be able to treat BL with similar effectiveness but with fewer side effects. Researchers are interested in confirming the results of previous studies that investigated the effectiveness of DA-EPOCH-R in treating BL.

Objectives:
  • To determine the safety and effectiveness of DA-EPOCH-R in treating Burkitt lymphoma.
Eligibility:
  • Individuals at least 18 years of age who have been diagnosed with Burkitt lymphoma and have not had any prior chemotherapy treatments.
Design:
  • Individuals will have a series of blood and other tests to determine their suitability for participating in the study. Eligible participants will be divided into high-risk and low-risk groups based on their disease prognosis and the possibility that the BL may or already has spread into the central nervous system.

  • Participants will receive intravenous infusion of the six chemotherapy drugs in DA-EPOCH-R in 21-day treatment cycles. The exact doses will be adjusted depending on participants white blood cell counts and other tests.

  • High-risk participants will receive six cycles of DA-EPOCH-R. To treat BL that may have entered the central nervous system, high-risk participants will also receive infusions of other chemotherapy drugs into their spinal fluid.

  • Low-risk participants will receive up to six cycles of DA-EPOCH-R, with an additional dose of rituximab during each cycle.

  • Frequent blood and urine tests will be performed during treatment, as well as body imaging scans and other tests of cancer progression as directed by the study doctors. Participants will receive additional medicines to help prevent possible adverse side effects of DA-EPOCH-R.

  • Participants who respond successfully to the treatment will be asked to return for follow-up exams every 3 months for the first 18 months, then every year for the next 3 years. Participants who do not respond successfully to the treatment will be given the opportunity to participate in additional research and treatment protocols, if any are available.

Detailed Description

Background:
  • Burkitt lymphoma/leukemia (BL) is highly curable. Standard treatment employs dose intense multi-agent chemotherapy and though effective is associated with high morbidity. Therefore, novel approaches are needed that improve the therapeutic index of BL while maintaining or improving efficacy. In human immunodeficiency virus (HIV)+ BL, outcome has been poor, mainly due to the use of cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate (Oncovin), and prednisone (CHOP) based regimens in this disease.

  • Two National Cancer Institute (NCI) phase II trials have used etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy with 1 or 2 doses of rituximab (R) per cycle in untreated BL. (Dose-adjusted) etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH)-Rituximab has been used in16 HIV negative BL, and 8 HIV positive patients have received 3 to 4 cycles of EPOCHRR to minimize toxicity and risk of opportunistic infections. All patients remain in continuous remission. Treatment was very well tolerated and represents a novel therapeutic strategy in BL.

  • This trial seeks to assess the effectiveness of a risk adaptive approach with DA-EPOCHR in untreated BL (HIV+/-). Because this treatment represents a major conceptual departure from standard treatment, it is important to obtain additional Phase II results in limited/advanced stage BL

  • c-MYC positive Diffuse large B cell (DLBCL) is a rare variant of Diffuse Large B-Cell Lymphoma (DLBCL). There is very little data on the biology of this disease and what the optimal therapeutic approach should be has not been defined. Therefore, based on our impression that this behaves aggressively and is likely characterized by a high tumor proliferation rate, we plan to accrue patients with this disease in addition to BL patients.

  • Plasmablastic lymphoma, another variant of DLBCL is frequently characterized by the activation of MYC and has had a poor outcome historically with standard treatment. We plan to include these patients in the study also. As they are cluster of differentiation 20 (CD20) negative, they will receive DA-EPOCH without Rituximab.

Objectives:
  • Determine progression free survival (PFS), event free survival (EFS) and overall survival (OS) of risk adaptive DA-EPOCH-R in untreated BL and c-MYC + DLBCL and DA-EPOCH in c-MYC+ plasmablastic lymphoma.

  • Assess predictive value of early fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) scans on PFS.

  • Obtain pilot comparative molecular profiling in HIV negative and positive BL and c- MYC

  • DLBCL, including c-MYC+ plasmablastic lymphoma.
Eligibility:
  • Burkitt lymphoma, c-MYC + DLBCL and c-MYC + plasmablastic lymphoma age greater than or equal to 18 years.

  • No prior treatment except limited-field radiotherapy, short course of glucocorticoids and/or cyclophosphamide for an urgent problem at diagnosis.

  • Adequate major organ function unless impairment due to lymphoma.

Study Design:
  • Phase II Study of risk adapted DA-EPOCH-R in BL, c-MYC + DLBCL and DA-EPOCH in c-MYC+ plasmablastic lymphoma

  • Low risk: DA-EPOCH-RR x 3 cycles.

  • High risk , c-MYC + DLBCL and c-MYC+ plasmablastic lymphoma : DA-EPOCH (+/-) R x 6 cycles or 8 cycles in select patients.

  • Cerebrospinal fluid (CSF) cytology and flow cytometry for analysis of BL.

  • High Risk CSF negative - Prophylactic intrathecal treatment

  • CSF positive - Active intrathecal treatment

  • FDG-PET/CT pre- and post-cycle 2 in all patients.

  • A total of 194 patients will be enrolled in the protocol.

Study Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Dose-Adjusted EPOCH+/-Rituximab in Adults With Untreated Burkitt Lymphoma, c-MYC Positive Diffuse Large B-Cell Lymphoma and Plasmablastic Lymphoma
Actual Study Start Date :
Mar 25, 2010
Actual Primary Completion Date :
Sep 30, 2020
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group A - Burkitt lymphoma Low Risk Arm

Burkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Drug: EPOCH-RR
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 3 cycles
Other Names:
  • Etoposide
  • Prednisone
  • Vincristine
  • Cyclophosphamide
  • Doxorubicin
  • Rituximab
  • Experimental: Group B - Burkitt lymphoma High Risk Arm

    Burkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

    Drug: EPOCH-R
    Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
    Other Names:
  • Etoposide
  • Prednisone
  • Vincristine
  • Cyclophosphamide
  • Doxorubicin
  • Rituximab
  • Experimental: Group C - DLBCL high risk arm

    Diffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

    Drug: EPOCH-R
    Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
    Other Names:
  • Etoposide
  • Prednisone
  • Vincristine
  • Cyclophosphamide
  • Doxorubicin
  • Rituximab
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval [Time of progression or death at 4 years]

      PFS is the time interval from start of treatment to documented evidence of disease progression. Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.

    2. Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval [At 4 years]

      EFS was determined from the date of enrolment in the study until the date of progression, last documentation of disease at or after the last treatment cycle, death, or last follow-up (whichever occurred first). Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.

    3. Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval [At 4 years]

      OS was calculated from the enrolment date until date of death or last follow-up using the Kaplan Meier. Kaplan-Meier curves were constructed with an 95% confidence interval.

    Secondary Outcome Measures

    1. Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2 [After 2 cycles of therapy and prior to cycle 3]

      The predictive value of early FDG-PET/CT scans on PFS was assessed after cycle 2. PFS is the time interval from start of treatment to documented evidence of disease progression, assessed by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.

    Other Outcome Measures

    1. Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) [Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.]

      Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:
    Patients must have one of the following histologic diagnoses:

    -Patients must have Burkitt Lymphoma. Effective with Amendment J (version date: 06/24/2014), the following histologies were removed as the maximum number allowed for these sub-groups has been reached: B-cell lymphoma: unclassifiable with features intermediate between Diffuse Large B cell lymphoma and Burkitt Lymphoma ; c-MYC + Diffuse large B-cell lymphoma (DLBCL) and c-MYC+ plasmablastic lymphoma.

    If questions arise related to diagnosis, please contact the National Cancer Institute (NCI) Principal Investigator, Dr. Mark Roschewski or the NCI study coordinator, A. Nicole Lucas.

    • Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) in patients <18 years of age, children are excluded from this study, but may be eligible for future pediatric trials

    • Pathology confirmed by treating institutions Pathology Department.

    • No prior treatment except patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids, cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture.

    • All disease stages.

    • Human immunodeficiency virus (HIV) negative or positive.

    • HIV positive patients on antiretroviral therapy regimen must be willing to suspend all Highly Active Antiretroviral Therapy (HAART) except in circumstances described in section 6.5.

    • Eastern Cooperative Oncology Group (ECOG) 0-4

    • Ability of patient or durable power of attorney (DPA) for healthcare to give informed consent.

    • Hepatitis B + patients may be enrolled at the discretion of the investigator.

    EXCLUSION CRITERIA:
    • Patients with Primary central nervous system (CNS) Lymphoma.

    • Inadequate renal function, defined as serum creatinine (Cr) > 1.5 or creatinine clearance < 50ml/min/1.73m^2 unless lymphoma related.

    • Inadequate hepatic or hematological function: as follows, unless lymphoma-/disease-related: bilirubin greater than 2 mg/dl (total) except greater than 5 mg/dl in patients with Gilbert's syndrome as defined by greater than 80% unconjugated, absolute neutrophil count (ANC) less than 1000 and platelets less than 75,000.

    • The effects of EPOCH-R on the developing human fetus are unknown. For this reason and because chemotherapy agents are known to be teratogenic, female subject of child-bearing potential not willing to use an acceptable method of birth control(i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion will not be eligible to participate in the study.

    • Female subject pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-human chorionic gonadotropin (hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for women without child-bearing potential.

    • The effects of EPOCH-R on the developing human fetus are unknown. For this reason and because chemotherapy agents are known to be teratogenic, male subject unwilling to use an acceptable method for contraception for the duration of the study and one year beyond treatment completion, will not be eligible to participate in the study.

    • History of a prior invasive malignancy in past 5 years.

    • Active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If echo is obtained the left ventricular ejection fraction (LVEF) should exceed 40%.

    • Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.

    • HIV positive patients with advanced immune suppression and evidence of HIV resistant to all combinations of antiretroviral therapy considered at high risk of non lymphoma related death within 12-months due to other acquired immunodeficiency syndrome (AIDS) complications should not be enrolled on the study.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1UC San Diego Moores Cancer CenterLa JollaCaliforniaUnited States92093
    2UCLA Center for Clinical AIDS Research and EducationLos AngelesCaliforniaUnited States90025
    3Emory University /Winship Cancer InstituteAtlantaGeorgiaUnited States30322
    4University of IllinoisChicagoIllinoisUnited States60607
    5University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowaUnited States52242
    6University of Kentucky /Markey Cancer CenterLexingtonKentuckyUnited States40536
    7National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMarylandUnited States20892
    8Massachusetts General Hospital Cancer CentersBostonMassachusettsUnited States02114
    9Dana Farber Cancer InstituteBostonMassachusettsUnited States02115
    10Beth Israel Deaconess Medical CenterBostonMassachusettsUnited States
    11West Michigan Cancer CenterKalamazooMichiganUnited States49007
    12Fairview - Southdale HospitalEdinaMinnesotaUnited States
    13Unity HospitalFridleyMinnesotaUnited States55432
    14Park Nicollet Clinic - Saint Louis ParkSaint Louis ParkMinnesotaUnited States55416
    15Washington University School of MedicineSaint LouisMissouriUnited States
    16University of Nebraska Medical CenterOmahaNebraskaUnited States68198
    17Montefiore Medical Center - Moses CampusBronxNew YorkUnited States10467
    18Mount Sinai HospitalNew YorkNew YorkUnited States10017
    19Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States11570
    20University of RochesterRochesterNew YorkUnited States14627
    21Vidant Oncology-KinstonKinstonNorth CarolinaUnited States28501
    22Wake Forest University Health SciencesWinston-SalemNorth CarolinaUnited States27157
    23Case Western Reserve UniversityClevelandOhioUnited States44106-2602
    24MetroHealth Medical CenterClevelandOhioUnited States44109
    25Cleveland ClinicClevelandOhioUnited States
    26University of Tennessee - KnoxvilleKnoxvilleTennesseeUnited States37996
    27UT Southwestern /Simmons Cancer Center- DallasDallasTexasUnited States75390
    28MD Anderson Cancer CenterHoustonTexasUnited States77030-4096
    29University of Wisconsin Hospital and ClinicsMadisonWisconsinUnited States53792
    30Froedtert and the Medical College of WisconsinMilwaukeeWisconsinUnited States53226

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Mark J Roschewski, M.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Mark Roschewski, M.D., Principal Investigator, National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT01092182
    Other Study ID Numbers:
    • 100052
    • 10-C-0052
    First Posted:
    Mar 24, 2010
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Mark Roschewski, M.D., Principal Investigator, National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleLow-risk Burkitt Lymphoma (BL)High-Risk Burkitt Lymphoma (BL)High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
    Arm/Group DescriptionBurkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesBurkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesHigh-Risk Diffuse Large B Cell Lymphoma Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
    Period Title: Overall Study
    STARTED159881
    COMPLETED148053
    NOT COMPLETED11828

    Baseline Characteristics

    Arm/Group TitleGroup A - Low-risk Burkitt Lymphoma (BL)Group B - High-Risk Burkitt Lymphoma (BL)Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)Total
    Arm/Group DescriptionBurkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesBurkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesDiffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesTotal of all reporting groups
    Overall Participants159881194
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    13
    86.7%
    84
    85.7%
    55
    67.9%
    152
    78.4%
    >=65 years
    2
    13.3%
    14
    14.3%
    26
    32.1%
    42
    21.6%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    51.47
    (14.85)
    46.35
    (17.53)
    57.47
    (14)
    51.39
    (16.74)
    Sex: Female, Male (Count of Participants)
    Female
    4
    26.7%
    20
    20.4%
    20
    24.7%
    44
    22.7%
    Male
    11
    73.3%
    78
    79.6%
    61
    75.3%
    150
    77.3%
    Race/Ethnicity, Customized (Count of Participants)
    Black or African American
    2
    13.3%
    16
    16.3%
    6
    7.4%
    24
    12.4%
    White
    11
    73.3%
    65
    66.3%
    66
    81.5%
    142
    73.2%
    Indian or Alaska Native
    1
    6.7%
    0
    0%
    0
    0%
    1
    0.5%
    Indian or Alaska Native + White
    0
    0%
    1
    1%
    0
    0%
    1
    0.5%
    Asian
    1
    6.7%
    5
    5.1%
    2
    2.5%
    8
    4.1%
    Race Unknown/Not Reported
    0
    0%
    11
    11.2%
    7
    8.6%
    18
    9.3%
    Hispanic or Latino
    1
    6.7%
    10
    10.2%
    4
    4.9%
    15
    7.7%
    Not Hispanic or Latino
    14
    93.3%
    80
    81.6%
    72
    88.9%
    166
    85.6%
    Ethnicity Unknown/Not Reported
    0
    0%
    8
    8.2%
    5
    6.2%
    13
    6.7%
    Region of Enrollment (participants) [Number]
    United States
    15
    100%
    98
    100%
    81
    100%
    194
    100%
    Eastern Cooperative Oncology Group (ECOG) (Count of Participants)
    0
    11
    73.3%
    39
    39.8%
    26
    32.1%
    76
    39.2%
    1
    4
    26.7%
    38
    38.8%
    37
    45.7%
    79
    40.7%
    2
    0
    0%
    14
    14.3%
    9
    11.1%
    23
    11.9%
    3
    0
    0%
    4
    4.1%
    7
    8.6%
    11
    5.7%
    4
    0
    0%
    3
    3.1%
    2
    2.5%
    5
    2.6%
    Baseline Risk Stratification (Count of Participants)
    Low Risk
    15
    100%
    0
    0%
    0
    0%
    15
    7.7%
    High Risk
    0
    0%
    98
    100%
    81
    100%
    179
    92.3%
    International Prognostic Index Score 0-5 (Count of Participants)
    0
    12
    80%
    8
    8.2%
    7
    8.6%
    27
    13.9%
    1
    3
    20%
    19
    19.4%
    7
    8.6%
    29
    14.9%
    2
    0
    0%
    20
    20.4%
    28
    34.6%
    48
    24.7%
    3
    0
    0%
    24
    24.5%
    30
    37%
    54
    27.8%
    4
    0
    0%
    24
    24.5%
    5
    6.2%
    29
    14.9%
    5
    0
    0%
    3
    3.1%
    4
    4.9%
    7
    3.6%
    Histology (Count of Participants)
    High Grade B Cell Lymphoma Double-hit (HGBL DH)
    NA
    NaN
    NA
    NaN
    24
    29.6%
    NA
    NaN
    High Grade B Cell Lymphoma Not Otherwise Specified (HGBL NOS)
    NA
    NaN
    NA
    NaN
    12
    14.8%
    NA
    NaN
    Diffuse Large B-Cell Lymphoma (DLBCL)
    NA
    NaN
    NA
    NaN
    44
    54.3%
    NA
    NaN
    Plasmablastic
    NA
    NaN
    NA
    NaN
    1
    1.2%
    NA
    NaN

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval
    DescriptionPFS is the time interval from start of treatment to documented evidence of disease progression. Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
    Time FrameTime of progression or death at 4 years

    Outcome Measure Data

    Analysis Population Description
    Those participants that were not analyzed for PFS were screen failures (did not have MYC+ Diffuse Large B-Cell Lymphoma (DLBCL).
    Arm/Group TitleGroup A - Low-risk Burkitt Lymphoma (BL)Group B - High-Risk Burkitt Lymphoma (BL)Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
    Arm/Group DescriptionBurkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesBurkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesDiffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
    Measure Participants159853
    Number (95% Confidence Interval) [percentage of participants]
    100
    666.7%
    82.1
    83.8%
    71.0
    87.7%
    2. Primary Outcome
    TitlePercentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval
    DescriptionEFS was determined from the date of enrolment in the study until the date of progression, last documentation of disease at or after the last treatment cycle, death, or last follow-up (whichever occurred first). Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
    Time FrameAt 4 years

    Outcome Measure Data

    Analysis Population Description
    Those participants that were not analyzed for EFS were screen failures (did not have MYC+ Diffuse Large B-Cell Lymphoma (DLBCL).
    Arm/Group TitleGroup A - Low-risk Burkitt Lymphoma (BL)Group B - High-Risk Burkitt Lymphoma (BL)Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
    Arm/Group DescriptionBurkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesBurkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesDiffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
    Measure Participants159853
    Number (95% Confidence Interval) [percentage of participants]
    100
    666.7%
    82.1
    83.8%
    71.0
    87.7%
    3. Primary Outcome
    TitlePercentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval
    DescriptionOS was calculated from the enrolment date until date of death or last follow-up using the Kaplan Meier. Kaplan-Meier curves were constructed with an 95% confidence interval.
    Time FrameAt 4 years

    Outcome Measure Data

    Analysis Population Description
    Those participants that were not analyzed for OS were screen failures (did not have MYC+ Diffuse Large B-Cell Lymphoma (DLBCL).
    Arm/Group TitleGroup A - Low-risk Burkitt Lymphoma (BL)Group B - High-Risk Burkitt Lymphoma (BL)Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
    Arm/Group DescriptionBurkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesBurkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesDiffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
    Measure Participants159853
    Number (95% Confidence Interval) [percentage of participants]
    100
    666.7%
    84.9
    86.6%
    76.7
    94.7%
    4. Secondary Outcome
    TitleKaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2
    DescriptionThe predictive value of early FDG-PET/CT scans on PFS was assessed after cycle 2. PFS is the time interval from start of treatment to documented evidence of disease progression, assessed by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
    Time FrameAfter 2 cycles of therapy and prior to cycle 3

    Outcome Measure Data

    Analysis Population Description
    51/98 participants and 34/81 participants did not receive a PET scan.
    Arm/Group TitleGroup A - Low-risk Burkitt Lymphoma (BL)Group B - High-Risk Burkitt Lymphoma (BL)Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
    Arm/Group DescriptionBurkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesBurkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesDiffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
    Measure Participants155134
    Number (95% Confidence Interval) [percentage of participants]
    100
    666.7%
    90.0
    91.8%
    78.7
    97.2%
    5. Other Pre-specified Outcome
    TitleNumber of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
    DescriptionHere is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
    Time FrameDate treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleGroup A - Low-risk Burkitt Lymphoma (BL)Group B - High-Risk Burkitt Lymphoma (BL)Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
    Arm/Group DescriptionBurkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesBurkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesDiffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
    Measure Participants159881
    Count of Participants [Participants]
    13
    86.7%
    87
    88.8%
    72
    88.9%

    Adverse Events

    Time FrameDate treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.
    Adverse Event Reporting Description
    Arm/Group TitleGroup A - Low-risk Burkitt Lymphoma (BL)Group B - High-Risk Burkitt Lymphoma (BL)Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
    Arm/Group DescriptionBurkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesBurkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cyclesDiffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
    All Cause Mortality
    Group A - Low-risk Burkitt Lymphoma (BL)Group B - High-Risk Burkitt Lymphoma (BL)Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/15 (0%) 16/98 (16.3%) 3/81 (3.7%)
    Serious Adverse Events
    Group A - Low-risk Burkitt Lymphoma (BL)Group B - High-Risk Burkitt Lymphoma (BL)Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total3/15 (20%) 58/98 (59.2%) 33/81 (40.7%)
    Blood and lymphatic system disorders
    Anemia1/15 (6.7%) 212/98 (12.2%) 214/81 (4.9%) 5
    Febrile neutropenia0/15 (0%) 027/98 (27.6%) 4811/81 (13.6%) 16
    Cardiac disorders
    Atrial fibrillation0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Cardiac arrest0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Cardiac disorders - Other, hypotension0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Chest pain - cardiac0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Myocardial infarction0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Restrictive cardiomyopathy0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Gastrointestinal disorders
    Abdominal distension0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Abdominal pain0/15 (0%) 02/98 (2%) 31/81 (1.2%) 1
    Colitis0/15 (0%) 02/98 (2%) 21/81 (1.2%) 1
    Diarrhea0/15 (0%) 00/98 (0%) 02/81 (2.5%) 3
    Gastric perforation0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Gastrointestinal disorders - Other, bleeding0/15 (0%) 02/98 (2%) 21/81 (1.2%) 1
    Ileus0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Jejunal perforation0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Lower gastrointestinal hemorrhage0/15 (0%) 02/98 (2%) 21/81 (1.2%) 1
    Mucositis oral0/15 (0%) 08/98 (8.2%) 110/81 (0%) 0
    Nausea0/15 (0%) 02/98 (2%) 22/81 (2.5%) 3
    Oral pain0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Pancreatitis0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Small intestinal obstruction0/15 (0%) 01/98 (1%) 20/81 (0%) 0
    Vomiting0/15 (0%) 03/98 (3.1%) 32/81 (2.5%) 3
    Gastrointestinal disorders - Other, heme positive stool0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Gastrointestinal disorders - Other, odynohagia0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    General disorders
    Death NOS0/15 (0%) 010/98 (10.2%) 109/81 (11.1%) 9
    Edema limbs0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Fatigue0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Fever0/15 (0%) 06/98 (6.1%) 71/81 (1.2%) 1
    General disorders and administration site conditions - Other, specify0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infusion related reaction0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Multi-organ failure0/15 (0%) 01/98 (1%) 12/81 (2.5%) 2
    Pain0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations
    Catheter related infection1/15 (6.7%) 10/98 (0%) 00/81 (0%) 0
    Device related infection0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, cellulitis0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Lung infection0/15 (0%) 03/98 (3.1%) 31/81 (1.2%) 1
    Phlebitis infective0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Sepsis0/15 (0%) 06/98 (6.1%) 64/81 (4.9%) 6
    Sinusitis0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Skin infection0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, clostridium difficile1/15 (6.7%) 10/98 (0%) 00/81 (0%) 0
    Infections and infestations - Other, influenza A/H1N10/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, Infected Cholecystostomy tube in setting of neutropenia?0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, neutropenic fever0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, liver infection0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Injury, poisoning and procedural complications
    Vascular access complication0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Investigations
    Alanine aminotransferase increased0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Aspartate aminotransferase increased0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Ejection fraction decreased0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Lymphocyte count decreased1/15 (6.7%) 17/98 (7.1%) 143/81 (3.7%) 7
    Neutrophil count decreased1/15 (6.7%) 111/98 (11.2%) 265/81 (6.2%) 8
    Platelet count decreased0/15 (0%) 06/98 (6.1%) 124/81 (4.9%) 6
    White blood cell decreased0/15 (0%) 015/98 (15.3%) 385/81 (6.2%) 7
    Metabolism and nutrition disorders
    Dehydration0/15 (0%) 03/98 (3.1%) 32/81 (2.5%) 2
    Hyperglycemia0/15 (0%) 02/98 (2%) 22/81 (2.5%) 2
    Hypoalbuminemia0/15 (0%) 00/98 (0%) 02/81 (2.5%) 3
    Hypocalcemia0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Hypokalemia0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Hyponatremia1/15 (6.7%) 13/98 (3.1%) 32/81 (2.5%) 2
    Hypophosphatemia0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Tumor lysis syndrome0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Musculoskeletal and connective tissue disorders
    Bone pain0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Myelodysplastic syndrome0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Treatment related secondary malignancy0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Nervous system disorders
    Cerebrospinal fluid leakage0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Dizziness0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Headache0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Intracranial hemorrhage0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Syncope0/15 (0%) 00/98 (0%) 04/81 (4.9%) 4
    Vasovagal reaction0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Psychiatric disorders
    Hallucinations0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Renal and urinary disorders
    Acute kidney injury0/15 (0%) 01/98 (1%) 13/81 (3.7%) 4
    Hematuria0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Proteinuria0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Renal and urinary disorders - Other, acute kidney injury0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Bronchopulmonary hemorrhage0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Hypoxia0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Pneumonitis0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Respiratory failure0/15 (0%) 01/98 (1%) 13/81 (3.7%) 3
    Respiratory, thoracic and mediastinal disorders - Other, specify0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Skin and subcutaneous tissue disorders
    Toxic epidermal necrolysis0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Vascular disorders
    Hematoma0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Hypertension0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Hypotension0/15 (0%) 04/98 (4.1%) 52/81 (2.5%) 2
    Thromboembolic event0/15 (0%) 03/98 (3.1%) 31/81 (1.2%) 1
    Other (Not Including Serious) Adverse Events
    Group A - Low-risk Burkitt Lymphoma (BL)Group B - High-Risk Burkitt Lymphoma (BL)Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total13/15 (86.7%) 88/98 (89.8%) 71/81 (87.7%)
    Blood and lymphatic system disorders
    Anemia6/15 (40%) 962/98 (63.3%) 21653/81 (65.4%) 181
    Blood and lymphatic system disorders - Other, DVT0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Febrile neutropenia1/15 (6.7%) 129/98 (29.6%) 4222/81 (27.2%) 35
    Leukocytosis0/15 (0%) 03/98 (3.1%) 32/81 (2.5%) 2
    Blood and lymphatic system disorders - Other, leukopenia0/15 (0%) 02/98 (2%) 40/81 (0%) 0
    Blood and lymphatic system disorders - Other, low ANC0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Blood and lymphatic system disorders - Other, low platelet count0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Blood and lymphatic system disorders - Other, T bili0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Blood and lymphatic system disorders - Other, thrombosis/embolism0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Cardiac disorders
    Acute coronary syndrome0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Atrial fibrillation0/15 (0%) 05/98 (5.1%) 62/81 (2.5%) 2
    Atrial flutter0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Cardiac disorders - Other, 23% decreased EF0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Chest pain - cardiac1/15 (6.7%) 11/98 (1%) 10/81 (0%) 0
    Palpitations0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Sinus bradycardia1/15 (6.7%) 12/98 (2%) 20/81 (0%) 0
    Sinus tachycardia0/15 (0%) 04/98 (4.1%) 44/81 (4.9%) 5
    Supraventricular tachycardia0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Ear and labyrinth disorders
    Ear pain0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Tinnitus0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Vertigo0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Endocrine disorders
    Adrenal insufficiency0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Eye disorders
    Blurred vision0/15 (0%) 03/98 (3.1%) 32/81 (2.5%) 2
    Eyelid function disorder0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Floaters0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Photophobia0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Retinal detachment0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Watering eyes0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Gastrointestinal disorders
    Abdominal distension0/15 (0%) 03/98 (3.1%) 30/81 (0%) 0
    Abdominal infection0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Abdominal pain2/15 (13.3%) 28/98 (8.2%) 115/81 (6.2%) 5
    Anal fistula0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Ascites0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Bloating0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Colitis0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Constipation6/15 (40%) 620/98 (20.4%) 2322/81 (27.2%) 37
    Diarrhea0/15 (0%) 018/98 (18.4%) 2017/81 (21%) 22
    Dry mouth0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Dyspepsia0/15 (0%) 02/98 (2%) 33/81 (3.7%) 3
    Dysphagia0/15 (0%) 04/98 (4.1%) 42/81 (2.5%) 2
    Enterocolitis0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Esophageal hemorrhage0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Esophagitis0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Fecal incontinence0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Flatulence1/15 (6.7%) 10/98 (0%) 02/81 (2.5%) 2
    Gastritis1/15 (6.7%) 11/98 (1%) 12/81 (2.5%) 2
    Gastroesophageal reflux disease0/15 (0%) 02/98 (2%) 22/81 (2.5%) 2
    Gastrointestinal disorders - Other, epigastric pain0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Hemorrhoids0/15 (0%) 03/98 (3.1%) 31/81 (1.2%) 2
    Ileus0/15 (0%) 01/98 (1%) 13/81 (3.7%) 4
    Mucositis oral1/15 (6.7%) 123/98 (23.5%) 4720/81 (24.7%) 31
    Nausea1/15 (6.7%) 318/98 (18.4%) 2511/81 (13.6%) 16
    Oral hemorrhage1/15 (6.7%) 10/98 (0%) 00/81 (0%) 0
    Oral pain1/15 (6.7%) 11/98 (1%) 11/81 (1.2%) 5
    Rectal hemorrhage0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Stomach pain0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Toothache1/15 (6.7%) 12/98 (2%) 20/81 (0%) 0
    Typhlitis0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Vomiting0/15 (0%) 09/98 (9.2%) 147/81 (8.6%) 8
    General disorders
    Chills1/15 (6.7%) 15/98 (5.1%) 62/81 (2.5%) 2
    Death NOS0/15 (0%) 02/98 (2%) 21/81 (1.2%) 1
    Edema limbs0/15 (0%) 03/98 (3.1%) 311/81 (13.6%) 12
    Fatigue4/15 (26.7%) 722/98 (22.4%) 2822/81 (27.2%) 35
    Fever1/15 (6.7%) 113/98 (13.3%) 168/81 (9.9%) 10
    Flu like symptoms0/15 (0%) 01/98 (1%) 12/81 (2.5%) 2
    Gait disturbance0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    General disorders and administration site conditions - Other, cerebellar infarct0/15 (0%) 02/98 (2%) 30/81 (0%) 0
    Infusion related reaction0/15 (0%) 02/98 (2%) 23/81 (3.7%) 3
    Neck edema0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Pain1/15 (6.7%) 110/98 (10.2%) 146/81 (7.4%) 7
    General disorders and administration site conditions - Other, sacral pressure ulcer0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    General disorders and administration site conditions - Other, thalmic infarct0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Hepatobiliary disorders
    Hepatic failure0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Immune system disorders
    Allergic reaction0/15 (0%) 03/98 (3.1%) 32/81 (2.5%) 2
    Infections and infestations
    Anorectal infection0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Bladder infection0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Bronchial infection0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Catheter related infection0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Enterocolitis infectious0/15 (0%) 02/98 (2%) 24/81 (4.9%) 4
    Esophageal infection0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Eye infection0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Infections and infestations - Other, bacteremia1/15 (6.7%) 10/98 (0%) 00/81 (0%) 0
    Lung infection0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Mucosal infection0/15 (0%) 08/98 (8.2%) 124/81 (4.9%) 5
    Peritoneal infection0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Rhinitis infective0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Sepsis0/15 (0%) 01/98 (1%) 12/81 (2.5%) 2
    Sinusitis0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Skin infection0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Upper respiratory infection1/15 (6.7%) 10/98 (0%) 01/81 (1.2%) 1
    Urethral infection0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Urinary tract infection0/15 (0%) 08/98 (8.2%) 98/81 (9.9%) 11
    Wound infection0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Infections and infestations - Other, Blood0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, blood infection0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, blood, E. coli0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, bacteremia, Klebsiella infection0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Infections and infestations - Other, candida oral infection0/15 (0%) 01/98 (1%) 20/81 (0%) 0
    Infections and infestations - Other, clostridium difficile0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, CMV reactivation0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Infections and infestations - Other, encephalitis, persistent0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, gastrointestinal tract0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, infection0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Infections and infestations - Other, infection-oral0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, L posterior lung0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, left orbital cellulitis0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, MRSA0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, oral cavity0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, parasitic infection0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, PICC line infection0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, polymicrobial bacteremia0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, throat0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Infections and infestations - Other, thrush0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, VRE0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Infections and infestations - Other, VRE-blood stream0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, blood, candida glabrata0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Infections and infestations - Other, herpes simplex oral ulcer0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Infections and infestations - Other, oral thrush0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Injury, poisoning and procedural complications
    Bruising0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Fall0/15 (0%) 02/98 (2%) 21/81 (1.2%) 1
    Investigations
    Activated partial thromboplastin time prolonged0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Alanine aminotransferase increased2/15 (13.3%) 215/98 (15.3%) 237/81 (8.6%) 14
    Alkaline phosphatase increased0/15 (0%) 07/98 (7.1%) 1012/81 (14.8%) 21
    Aspartate aminotransferase increased1/15 (6.7%) 113/98 (13.3%) 187/81 (8.6%) 12
    Blood bilirubin increased2/15 (13.3%) 29/98 (9.2%) 135/81 (6.2%) 9
    CD4 lymphocytes decreased0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Cardiac troponin I increased0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Cardiac troponin T increased0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Creatinine increased0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Elevated LFT's0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Elevated bilirubin0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    GGT increased0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Investigations - Other, disease progression0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Lipase increased0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Lymphocyte count decreased5/15 (33.3%) 1154/98 (55.1%) 27749/81 (60.5%) 239
    Lymphocyte count increased0/15 (0%) 01/98 (1%) 13/81 (3.7%) 3
    Neutrophil count decreased5/15 (33.3%) 655/98 (56.1%) 20149/81 (60.5%) 178
    Pancreatic enzymes decreased0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Platelet count decreased3/15 (20%) 352/98 (53.1%) 16143/81 (53.1%) 159
    Urine output decreased0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Weight gain0/15 (0%) 03/98 (3.1%) 51/81 (1.2%) 1
    Weight loss0/15 (0%) 02/98 (2%) 25/81 (6.2%) 8
    White blood cell decreased7/15 (46.7%) 1047/98 (48%) 21252/81 (64.2%) 218
    Investigations - Other, heartburn0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Investigations - Other, night sweats0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Investigations - Other, fluid overload0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Metabolism and nutrition disorders
    Alkalosis0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Anorexia1/15 (6.7%) 19/98 (9.2%) 106/81 (7.4%) 7
    Dehydration0/15 (0%) 07/98 (7.1%) 112/81 (2.5%) 3
    Glucose intolerance0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Hypercalcemia0/15 (0%) 01/98 (1%) 13/81 (3.7%) 3
    Hyperglycemia0/15 (0%) 016/98 (16.3%) 4215/81 (18.5%) 37
    Hyperkalemia0/15 (0%) 03/98 (3.1%) 33/81 (3.7%) 3
    Hypermagnesemia1/15 (6.7%) 12/98 (2%) 23/81 (3.7%) 4
    Hypernatremia0/15 (0%) 04/98 (4.1%) 58/81 (9.9%) 17
    Hypertriglyceridemia0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Hyperuricemia0/15 (0%) 01/98 (1%) 12/81 (2.5%) 2
    Hypoalbuminemia0/15 (0%) 018/98 (18.4%) 3215/81 (18.5%) 27
    Hypocalcemia0/15 (0%) 017/98 (17.3%) 3217/81 (21%) 28
    Hypoglycemia0/15 (0%) 04/98 (4.1%) 73/81 (3.7%) 3
    Hypokalemia1/15 (6.7%) 121/98 (21.4%) 3218/81 (22.2%) 36
    Hypomagnesemia0/15 (0%) 07/98 (7.1%) 136/81 (7.4%) 16
    Hyponatremia1/15 (6.7%) 114/98 (14.3%) 196/81 (7.4%) 8
    Hypophosphatemia2/15 (13.3%) 222/98 (22.4%) 3620/81 (24.7%) 29
    Metabolism and nutrition disorders - Other, elevated LDH0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Tumor lysis syndrome0/15 (0%) 04/98 (4.1%) 40/81 (0%) 0
    Metabolism and nutrition disorders - Other, malnutrition0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Back pain1/15 (6.7%) 17/98 (7.1%) 107/81 (8.6%) 7
    Bone pain2/15 (13.3%) 39/98 (9.2%) 137/81 (8.6%) 10
    Chest wall pain0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Flank pain0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Generalized muscle weakness1/15 (6.7%) 14/98 (4.1%) 75/81 (6.2%) 6
    Joint effusion0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Muscle weakness lower limb0/15 (0%) 01/98 (1%) 20/81 (0%) 0
    Muscle weakness trunk0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Musculoskeletal and connective tissue disorder - Other, specify0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Myalgia1/15 (6.7%) 10/98 (0%) 01/81 (1.2%) 2
    Neck pain1/15 (6.7%) 13/98 (3.1%) 31/81 (1.2%) 1
    Non-cardiac chest pain0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Pain in extremity0/15 (0%) 02/98 (2%) 33/81 (3.7%) 4
    Musculoskeletal and connective tissue disorder - Other, shin pain with numbness0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Nervous system disorders
    Cerebrospinal fluid leakage0/15 (0%) 02/98 (2%) 30/81 (0%) 0
    Cognitive disturbance0/15 (0%) 01/98 (1%) 20/81 (0%) 0
    Depressed level of consciousness0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Dizziness0/15 (0%) 07/98 (7.1%) 93/81 (3.7%) 5
    Dysgeusia0/15 (0%) 01/98 (1%) 15/81 (6.2%) 6
    Dysphasia0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Facial nerve disorder0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Headache1/15 (6.7%) 225/98 (25.5%) 3111/81 (13.6%) 13
    Memory impairment0/15 (0%) 02/98 (2%) 51/81 (1.2%) 1
    Movements involuntary0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Nervous system disorders - Other, numbness in left arm1/15 (6.7%) 30/98 (0%) 02/81 (2.5%) 6
    Paresthesia0/15 (0%) 05/98 (5.1%) 53/81 (3.7%) 10
    Peripheral motor neuropathy0/15 (0%) 08/98 (8.2%) 98/81 (9.9%) 9
    Peripheral sensory neuropathy5/15 (33.3%) 526/98 (26.5%) 3322/81 (27.2%) 25
    Presyncope0/15 (0%) 02/98 (2%) 42/81 (2.5%) 2
    Seizure0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Somnolence0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Syncope0/15 (0%) 05/98 (5.1%) 72/81 (2.5%) 2
    Tremor0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Nervous system disorders - Other, neuropathy1/15 (6.7%) 10/98 (0%) 01/81 (1.2%) 5
    Nervous system disorders - Other, neuropathy, upper bilateral extremities2/15 (13.3%) 20/98 (0%) 00/81 (0%) 0
    Psychiatric disorders
    Agitation0/15 (0%) 02/98 (2%) 21/81 (1.2%) 1
    Anxiety0/15 (0%) 01/98 (1%) 12/81 (2.5%) 2
    Confusion0/15 (0%) 03/98 (3.1%) 32/81 (2.5%) 2
    Delirium0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Delusions0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Depression0/15 (0%) 03/98 (3.1%) 31/81 (1.2%) 1
    Insomnia1/15 (6.7%) 110/98 (10.2%) 126/81 (7.4%) 6
    Personality change0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Psychiatric disorders - Other, non verbal0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Renal and urinary disorders
    Acute kidney injury0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Hematuria0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Renal and urinary disorders - Other, dysuria0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Urinary frequency0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Urinary tract pain1/15 (6.7%) 11/98 (1%) 12/81 (2.5%) 2
    Urinary urgency0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Reproductive system and breast disorders
    Scrotal pain0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Respiratory, thoracic and mediastinal disorders
    Allergic rhinitis0/15 (0%) 01/98 (1%) 12/81 (2.5%) 2
    Aspiration0/15 (0%) 00/98 (0%) 03/81 (3.7%) 3
    Cough0/15 (0%) 06/98 (6.1%) 61/81 (1.2%) 1
    Dyspnea1/15 (6.7%) 18/98 (8.2%) 97/81 (8.6%) 9
    Epistaxis0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Hiccups0/15 (0%) 03/98 (3.1%) 30/81 (0%) 0
    Hoarseness0/15 (0%) 02/98 (2%) 21/81 (1.2%) 1
    Hypoxia0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Laryngeal inflammation0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Laryngeal mucositis0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Nasal congestion0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Pharyngeal mucositis0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Pharyngolaryngeal pain0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Pleural effusion0/15 (0%) 01/98 (1%) 12/81 (2.5%) 2
    Pneumonitis0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Postnasal drip0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Productive cough0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Pulmonary edema0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Respiratory failure0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Sleep apnea1/15 (6.7%) 31/98 (1%) 10/81 (0%) 0
    Sore throat0/15 (0%) 04/98 (4.1%) 51/81 (1.2%) 1
    Tracheal fistula0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Skin and subcutaneous tissue disorders
    Alopecia4/15 (26.7%) 69/98 (9.2%) 146/81 (7.4%) 6
    Dry skin0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Hyperhidrosis0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Nail discoloration0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Nail loss0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Pain of skin0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Papulopustular rash0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Pruritus0/15 (0%) 03/98 (3.1%) 31/81 (1.2%) 1
    Rash acneiform0/15 (0%) 00/98 (0%) 03/81 (3.7%) 3
    Rash maculo-papular0/15 (0%) 01/98 (1%) 11/81 (1.2%) 1
    Rash pustular0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Skin and subcutaneous tissue disorders - Other, abdominal abscess2/15 (13.3%) 24/98 (4.1%) 51/81 (1.2%) 1
    Skin hyperpigmentation0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Skin ulceration0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Urticaria0/15 (0%) 00/98 (0%) 02/81 (2.5%) 2
    Skin and subcutaneous tissue disorders - Other, blister ball of R foot0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Skin and subcutaneous tissue disorders - Other, dermatitis0/15 (0%) 00/98 (0%) 01/81 (1.2%) 1
    Skin and subcutaneous tissue disorders - Other, forehead itching0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Skin and subcutaneous tissue disorders - Other, skin darkening1/15 (6.7%) 10/98 (0%) 00/81 (0%) 0
    Skin and subcutaneous tissue disorders - Other, vitiligo1/15 (6.7%) 10/98 (0%) 00/81 (0%) 0
    Skin and subcutaneous tissue disorders - Other, pressure ulcer0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Skin and subcutaneous tissue disorders - Other, scalp wound0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Vascular disorders
    Hematoma0/15 (0%) 03/98 (3.1%) 40/81 (0%) 0
    Hot flashes0/15 (0%) 01/98 (1%) 10/81 (0%) 0
    Hypertension1/15 (6.7%) 15/98 (5.1%) 96/81 (7.4%) 12
    Hypotension0/15 (0%) 08/98 (8.2%) 96/81 (7.4%) 8
    Superficial thrombophlebitis0/15 (0%) 02/98 (2%) 20/81 (0%) 0
    Thromboembolic event0/15 (0%) 06/98 (6.1%) 65/81 (6.2%) 5

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr. Mark J. Roschewski
    OrganizationNational Cancer Institute
    Phone240-760-6183
    Emailroschewskimj@nih.gov
    Responsible Party:
    Mark Roschewski, M.D., Principal Investigator, National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT01092182
    Other Study ID Numbers:
    • 100052
    • 10-C-0052
    First Posted:
    Mar 24, 2010
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Nov 1, 2021