Lenalidomide as Maintenance Therapy After Combination Chemotherapy With or Without Rituximab and Stem Cell Transplant in Treating Patients With Persistent or Recurrent Non-Hodgkin Lymphoma That Is Resistant to Chemotherapy

Sponsor
University of Nebraska (Other)
Overall Status
Completed
CT.gov ID
NCT01035463
Collaborator
National Cancer Institute (NCI) (NIH)
74
3
1
104.4
24.7
0.2

Study Details

Study Description

Brief Summary

This phase I/II trial studies the side effects and best dose of lenalidomide when given after combination chemotherapy with or without rituximab and stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma that has not responded to treatment or has returned after a period of improvement and is resistant to chemotherapy. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting certain cells. Giving lenalidomide after combination chemotherapy with or without rituximab may work better in treating patients with non-Hodgkin lymphoma.

Detailed Description

PRIMARY OBJECTIVES:
  1. To establish the maximum tolerated dose (MTD) of lenalidomide given in the post-transplant setting for a 12 month maintenance period.
SECONDARY OBJECTIVES:
  1. To obtain preliminary estimates of the 1-year response rate, event-free and overall survival using this regimen.

OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study.

PRE-CONDITIONING (patients with cluster of differentiation [CD]20+ non-Hodgkin lymphoma):

Patients receive rituximab intravenously (IV) per standard of care.

PREPARATIVE REGIMEN: Patients receive carmustine IV on day -6, etoposide IV twice daily (BID) and cytarabine IV BID on days -5 through -2, and melphalan IV on day -1.

AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0.

MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide orally (PO) on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of Lenalidomide Maintenance Following BEAM (+/- Rituximab) for Chemo-Resistant or High Risk Non-Hodgkin?s Lymphoma
Actual Study Start Date :
Nov 12, 2009
Actual Primary Completion Date :
Jul 27, 2017
Actual Study Completion Date :
Jul 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (stem cell transplantation)

PRE-CONDITIONING (patients with CD20+ NHL): Patients receive rituximab IV per standard of care. PREPARATIVE REGIMEN: Patients receive carmustine IV on day -6, etoposide IV BID and cytarabine IV BID on days -5 through -2, and melphalan IV on day -1. AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous hematopoietic stem cell transplant
Other Names:
  • Autologous Hematopoietic Cell Transplantation
  • autologous stem cell transplantation
  • Drug: Carmustine
    Given IV
    Other Names:
  • BCNU
  • Becenum
  • Becenun
  • BiCNU
  • Bis(chloroethyl) Nitrosourea
  • Bis-Chloronitrosourea
  • Carmubris
  • Carmustin
  • Carmustinum
  • FDA 0345
  • Gliadel
  • N,N'-Bis(2-chloroethyl)-N-nitrosourea
  • Nitrourean
  • Nitrumon
  • SK 27702
  • SRI 1720
  • WR-139021
  • Drug: Cytarabine
    Given IV
    Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Beta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
  • Drug: Etoposide
    Given IV
    Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213
  • Drug: Lenalidomide
    Given PO
    Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
  • Drug: Melphalan
    Given IV
    Other Names:
  • Alanine Nitrogen Mustard
  • CB-3025
  • L-PAM
  • L-Phenylalanine Mustard
  • L-sarcolysin
  • L-Sarcolysin Phenylalanine mustard
  • L-Sarcolysine
  • Melphalanum
  • Phenylalanine Mustard
  • Phenylalanine nitrogen mustard
  • Sarcoclorin
  • Sarkolysin
  • WR-19813
  • Biological: Rituximab
    Given IV
    Other Names:
  • ABP 798
  • BI 695500
  • C2B8 Monoclonal Antibody
  • Chimeric Anti-CD20 Antibody
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 Monoclonal Antibody
  • MabThera
  • Monoclonal Antibody IDEC-C2B8
  • PF-05280586
  • Rituxan
  • Rituximab Biosimilar ABP 798
  • Rituximab Biosimilar BI 695500
  • Rituximab Biosimilar CT-P10
  • Rituximab Biosimilar GB241
  • Rituximab Biosimilar IBI301
  • Rituximab Biosimilar PF-05280586
  • Rituximab Biosimilar RTXM83
  • Rituximab Biosimilar SAIT101
  • RTXM83
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose of Lenalidomide (Phase I) [Cycle 1, 28 days]

      The Maximum Tolerated Dose (MTD) is defined to be the dose cohort below which 3 out of 6 subjects experience dose limiting toxicities during cycle 1. Dose limiting toxicities graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    Secondary Outcome Measures

    1. Event-free Survival [1 year]

      The Kaplan-Meier method will be used to estimate the event-free survival distribution.

    2. Overall Survival [1 year]

      The Kaplan-Meier method will be used to estimate the overall survival distribution. This outcome only reports data as it pertains to overall survival at one year. All-cause mortality includes survival for follow up for all subjects on the study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Persistent, or relapsed non-Hodgkin's lymphoma (NHL) (any histology) that is chemo-resistant (< a partial response [PR]), subjects who have received >= 3 prior chemotherapy regimens, or subjects with lymphomas that have a high relapse rate following autologous or syngeneic stem cell transplantation (transformed NHL, peripheral T-cell lymphoma [PTCL], mantle cell lymphoma, anaplastic lymphoma kinase [ALK]-negative anaplastic large cell lymphoma [ALCL, alk neg]), intermediate International Prognostic Index (IPI) or high risk IPI or subjects with a positive positron emission tomography (PET) scan prior to transplant, and otherwise eligible for transplantation with adequate end-organ function

    • Subjects that relapse within one year of diagnosis

    • Able to collect >= 1.5 x 10^6 CD34+/kg cell for transplantation

    • Absolute neutrophil count (ANC) >= 1000 cells/mm^3 and platelet count >= 60 K when maintenance lenalidomide is started (day 100 post-transplant)

    • Subjects must have calculated creatinine clearance >= 30 ml/min

    • Total bilirubin =< 1.5 x upper limit of normal (ULN)

    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN

    • Subjects who are seropositive because of hepatitis B virus vaccine

    • Subjects must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

    • Able to adhere to the study visit schedule and other protocol requirements

    • Expected survival duration of >= six months

    • Karnofsky performance status >= 70

    • Subjects > age 60 or with clinical signs of heart disease must have ejection fraction

    = 45% left ventricular ejection fraction (LVEF) pre-transplant

    • Subjects with clinical signs of pulmonary insufficiency must have diffusion capacity of the lung for carbon monoxide (DLCO) to be measured at >= 50% of predicted value

    • No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study

    • Disease free of prior malignancies for >= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast or low risk prostate cancer after curative therapy

    • All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of Revlimid REMS program

    • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, as least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy

    • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program

    • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (subjects intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)

    • Male subject agrees to use an acceptable method for contraception for the duration of the study

    Exclusion Criteria:
    • Chemosensitive NHL, except subjects receiving >= 3 prior chemotherapy regimens, or subjects having transformed NHL, PTCL, mantle cell lymphoma (MCL) or ALCL, alk neg

    • End-organ function not appropriate for transplantation

    • Inability to collect adequate stem cells

    • Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type B (HBV) or C (HCV) or active hepatitis

    • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

    • Pregnant or breast feeding females; (lactating females must agree not to breast feed while taking lenalidomide)

    • Known hypersensitivity to thalidomide or lenalidomide (if applicable)

    • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs

    • Any prior use of lenalidomide

    • Concurrent use of other anti-cancer agents or treatments

    • Serum creatinine > 2.0 mg/dL or calculated creatinine clearance < 30 ml/min

    • Active infection at the start of lenalidomide

    • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant

    • History of life threatening or recurrent thrombosis/embolism; subjects may participate if they are adequately anticoagulated during the treatment

    • Subject has > grade 2 peripheral neuropathy within 14 days before enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    2 University of Nebraska Medical Center Omaha Nebraska United States 68198
    3 Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland Ohio United States 44106

    Sponsors and Collaborators

    • University of Nebraska
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Julie Vose, University of Nebraska

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Julie M Vose, MD, Principal Investigator, University of Nebraska
    ClinicalTrials.gov Identifier:
    NCT01035463
    Other Study ID Numbers:
    • 446-08
    • NCI-2009-01436
    • RV-LYM-PI-0328
    • 446-08
    • P30CA036727
    First Posted:
    Dec 18, 2009
    Last Update Posted:
    Nov 8, 2019
    Last Verified:
    Nov 1, 2019

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 74 participants were consented, but only 59 subjects were treated on the study.
    Arm/Group Title Phase I - 10 mg Len Phase 1 - 15 mg Len Phase 1 - 20 mg Len Phase 1 - 25mg Len Phase II - 15 mg Len Phase II - 10 mg Len
    Arm/Group Description AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Based in Phase I data, the MTD was determined to be 15 mg but, the MTD for the study was based on cycle 1 of the Lenalidomide maintenance. However, there is cumulative toxicity of Lenalidomide, especially in the post-transplant setting which led to a need to lower the dose to 10 mg for the Phase II study. At the 10 mg dose, a much higher percentage of subjects were able to complete > 6 months of maintenance therapy. Therefore the dose for continued Phase II will be 10 mg. Based in Phase I data, the MTD was determined to be 15 mg but, the MTD for the study was based on cycle 1 of the Lenalidomide maintenance. However, there is cumulative toxicity of Lenalidomide, especially in the post-transplant setting which led to a need to lower the dose to 10 mg for the Phase II study. At the 10 mg dose, a much higher percentage of subjects were able to complete > 6 months of maintenance therapy. Therefore the dose for continued Phase II will be 10 mg.
    Period Title: Overall Study
    STARTED 6 3 6 4 7 33
    COMPLETED 6 1 1 2 1 15
    NOT COMPLETED 0 2 5 2 6 18

    Baseline Characteristics

    Arm/Group Title All Phase I Participants All Phase II Participants Total
    Arm/Group Description AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION AUTOLOGOUS HEMATOPOIETIC STEM CELL Total of all reporting groups
    Overall Participants 19 40 59
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    56.9
    (7.8)
    58.1
    (9.9)
    57.7
    (9.2)
    Sex: Female, Male (Count of Participants)
    Female
    8
    42.1%
    9
    22.5%
    17
    28.8%
    Male
    11
    57.9%
    31
    77.5%
    42
    71.2%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    0
    0%
    1
    2.5%
    1
    1.7%
    Black
    0
    0%
    1
    2.5%
    1
    1.7%
    White
    19
    100%
    38
    95%
    57
    96.6%
    Region of Enrollment (participants) [Number]
    United States
    19
    100%
    40
    100%
    59
    100%

    Outcome Measures

    1. Primary Outcome
    Title Maximum Tolerated Dose of Lenalidomide (Phase I)
    Description The Maximum Tolerated Dose (MTD) is defined to be the dose cohort below which 3 out of 6 subjects experience dose limiting toxicities during cycle 1. Dose limiting toxicities graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
    Time Frame Cycle 1, 28 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Treatment (Stem Cell Transplantation)
    Arm/Group Description Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    Measure Participants 19
    Number [milligrams PO daily]
    10
    2. Secondary Outcome
    Title Event-free Survival
    Description The Kaplan-Meier method will be used to estimate the event-free survival distribution.
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title All Phase I Participants All Phase II Participants
    Arm/Group Description Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    Measure Participants 19 40
    Number (95% Confidence Interval) [percentage of participants]
    84
    442.1%
    87
    217.5%
    3. Secondary Outcome
    Title Overall Survival
    Description The Kaplan-Meier method will be used to estimate the overall survival distribution. This outcome only reports data as it pertains to overall survival at one year. All-cause mortality includes survival for follow up for all subjects on the study.
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title All Phase I Participants All Phase II Participants
    Arm/Group Description Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    Measure Participants 19 40
    Number (95% Confidence Interval) [percentage of participants]
    100
    526.3%
    95
    237.5%

    Adverse Events

    Time Frame All subjects will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationship to study drug starting first day of study treatment to a minimum for 30 days following the last dose of Lenalidomide maintenance regardless (approximately 1 year). All-cause Mortality was assessed/monitored for the duration of the study, up to 8 years and 8.5 months.
    Adverse Event Reporting Description
    Arm/Group Title All Phase I Participants All Phase II Participants
    Arm/Group Description Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Post AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    All Cause Mortality
    All Phase I Participants All Phase II Participants
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/19 (21.1%) 7/40 (17.5%)
    Serious Adverse Events
    All Phase I Participants All Phase II Participants
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/19 (47.4%) 6/40 (15%)
    Blood and lymphatic system disorders
    Febrile neutropenia 1/19 (5.3%) 1 0/40 (0%) 0
    Gastrointestinal disorders
    abdominal pain 1/19 (5.3%) 1 0/40 (0%) 0
    rectal hemorrhage 1/19 (5.3%) 1 0/40 (0%) 0
    Hepatobiliary disorders
    Hepatobiliary disorders - Other 1/19 (5.3%) 1 0/40 (0%) 0
    Infections and infestations
    acute hepatitis 1/19 (5.3%) 1 0/40 (0%) 0
    bronchial infection 1/19 (5.3%) 1 0/40 (0%) 0
    Enterocolitis infectious 0/19 (0%) 0 1/40 (2.5%) 1
    Infection and infestation, Other 0/19 (0%) 0 1/40 (2.5%) 1
    Investigations
    Neutrophil count decreased 0/19 (0%) 0 1/40 (2.5%) 1
    Metabolism and nutrition disorders
    dehydration 1/19 (5.3%) 1 0/40 (0%) 0
    Nervous system disorders
    Transient ischemic attack 0/19 (0%) 0 1/40 (2.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Respiratory, throacic and mediastinal, Other 0/19 (0%) 0 1/40 (2.5%) 1
    Skin and subcutaneous tissue disorders
    skin and subcutaneous tissue disorder - Other 1/19 (5.3%) 1 1/40 (2.5%) 1
    Surgical and medical procedures
    Surgical and medical procedures - Other 1/19 (5.3%) 1 0/40 (0%) 0
    Other (Not Including Serious) Adverse Events
    All Phase I Participants All Phase II Participants
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/19 (73.7%) 24/40 (60%)
    Investigations
    neutrophil count decreased 10/19 (52.6%) 15/40 (37.5%)
    platelet count decreased 6/19 (31.6%) 2/40 (5%)
    white blood cell decreased 5/19 (26.3%) 5/40 (12.5%)
    Skin and subcutaneous tissue disorders
    rash 0/19 (0%) 2/40 (5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE 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/Title Julie M. Vose, MD
    Organization University of Nebraska Medical Center
    Phone 402-559-3848
    Email jmvose@unmc.edu
    Responsible Party:
    Julie M Vose, MD, Principal Investigator, University of Nebraska
    ClinicalTrials.gov Identifier:
    NCT01035463
    Other Study ID Numbers:
    • 446-08
    • NCI-2009-01436
    • RV-LYM-PI-0328
    • 446-08
    • P30CA036727
    First Posted:
    Dec 18, 2009
    Last Update Posted:
    Nov 8, 2019
    Last Verified:
    Nov 1, 2019