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Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00082888
Collaborator
(none)
93
Enrollment
2
Locations
1
Arm
159.4
Actual Duration (Months)
46.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial studies how well tipifarnib works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Tipifarnib may be an effective treatment for non-Hodgkin's lymphoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVES:

  1. To assess tumor response to R115777 (tipifarnib) in patients with relapsed aggressive non-Hodgkin's lymphoma. (Permanently closed to accrual 6/28/06) II. To assess tumor response to R115777 in patients with relapsed indolent non-Hodgkin's lymphoma. (Permanently closed to accrual 9/26/07) III. To assess tumor response to R115777 in patients with uncommon non-Hodgkin's lymphomas.

  2. To evaluate toxicity associated with this regimen in patients with relapsed non-Hodgkin's lymphoma.

SECONDARY OBJECTIVES:
  1. To evaluate known and unknown molecular markers that may predict for response to R115777 in lymphoma tissue.
OUTLINE:

Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Evaluation of FTI (R115777) in Treatment of Relapsed and Refractory Lymphoma
Actual Study Start Date :
Mar 24, 2004
Actual Primary Completion Date :
May 20, 2009
Actual Study Completion Date :
Jul 5, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (tipifarnib)

Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Tipifarnib
Given PO
Other Names:
  • R115777
  • Zarnestra

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants With Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment [During the first 6 cycles of treatment]

      Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.

    Secondary Outcome Measures

    1. Overall Survival [Up to 2 years]

      Overall survival time was defined as the time from registration to the date of death or last follow-up.

    2. Time to Progression [up to 2 years]

      Time to progression was defined as the number of months from registration to the date of disease progression with patients being progression-free being censored on the date of their last evaluation. Progression is defined as ≥50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or nonresponders or appearance of any new lesion during or at the end of therapy.

    3. Duration of Response [up to 2 years]

      Duration of response is defined for all evaluable patients that have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression (PD) is documented. CR:Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy PR:≥50% decrease in SPD of the six largest dominant nodes or nodal masses. PD:≥50 % increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders or appearance of any new lesion during or at the end of therapy.

    4. Number of Patients Who Experienced Grade 3 or 4 Toxicities [Up to 56 days]

      Number of patients that experienced a grade 3 or 4 toxicity (adverse events considered at least possibly related to Tipifarnib) as measured by NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL(Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.). Grade 4: Life-threatening consequences; urgent intervention indicated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Biopsy-proven relapsed or refractory lymphomas; previous biopsies =< 6 months prior to treatment on this protocol will be acceptable as long as there has not been intervening therapy; if the patient has received therapy for non-Hodgkin's disease (NHL) between the time of the last biopsy and this protocol, then a re-biopsy is necessary

    • STUDY 1: Aggressive lymphomas (permanently closed to accrual 6/28/06):

    • Transformed lymphomas

    • Diffuse large B cell lymphoma

    • Mantle cell lymphoma

    • Follicular lymphoma grade III STUDY 2: Indolent lymphomas (permanently closed to accrual 9/26/07)

    • Small lymphocytic lymphoma/chronic lymphocytic leukemia

    • Follicular lymphoma, grades 1, 2

    • Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) type

    • Nodal marginal zone B-cell lymphoma

    • Splenic marginal zone B-cell lymphoma

    STUDY 3: Uncommon lymphomas:

    • Peripheral T cell lymphoma, unspecified

    • Anaplastic large cell lymphoma (T and null cell type)

    • Lymphoplasmacytic lymphoma

    • Mycosis fungoides/ Sezary syndrome

    • Relapsed Hodgkin's disease (patients must be previously treated and either have had a transplant or not be eligible for a transplant)

    • Previously treated (no limitations on the number of prior therapies); patients with aggressive lymphoma (Study 1 - permanently closed to accrual 6/28/06) should have received or be ineligible for potentially curable therapy including stem cell transplant

    • MEASURABLE DISEASE: Must have at least one lesion that has a single diameter of

    = 2 cm or tumor cells in the blood >= 5 x10^9/L

    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

    • Absolute neutrophil count >=1000/mm^3

    • Platelet count >= 75,000

    • Hemoglobin >= 9 g/dL

    • Total bilirubin =< 2 x upper limit of normal (ULN) (if > 2 x ULN direct bilirubin is required and should be =< 1.5 x ULN)

    • Aspartate aminotransferase (AST) =< 3 x ULN (=< 5 x ULN if liver involvement is present)

    • Serum creatinine =< 2 x ULN

    • Expected survival >= 3 months

    • Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent

    • Capable of swallowing intact study medication tablets

    • Capable of following directions regarding taking study medication, or has a daily caregiver who will be responsible for administering study medication

    Exclusion Criteria:

    • Any of the following as this regimen may be harmful to a developing fetus or nursing child:

    • Pregnant women

    • Breastfeeding women

    • Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)

    • NOTE: The effects of R115777 on the developing human fetus at the recommended therapeutic dose are unknown

    • Life-threatening illness (unrelated to tumor)

    • Ongoing radiation therapy or radiation therapy =< 3 weeks prior to study registration unless the acute side effects associated with such therapy are resolved

    • Therapy with myelosuppressive chemotherapy, cytotoxic chemotherapy, or biologic therapy =< 3 weeks (6 weeks for nitrosourea or mitomycin C) or corticosteroids =< 2 weeks, prior to starting R11577; patients may be on corticosteroids or tapering off them up until the day they start R11577 as long as it is clear that they are not having a tumor response to the steroids or that the steroids would confuse the interpretation of response to R11577; patients may be receiving stable (not increased within the last month) chronic doses of corticosteroids with a maximum dose of 20 mg of prednisone per day if they are being given for disorders other than lymphoma such as rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or intractable symptoms of lymphoma

    • Peripheral neuropathy >= grade 3

    • Serious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectives

    • Presence of central nervous system (CNS) lymphoma

    • Other active malignancies

    • Once a patient begins FTI (tipifarnib) treatment, the addition of other cancer treatment will confound the assessment of efficacy and therefore is not allowed; this restriction precludes the addition of cytotoxic, immunologic agents, radiotherapy, or an increase in corticosteroid dose while the patient is in the treatment phase of this protocol

    • Known to be human immunodeficiency virus (HIV) positive; HIV testing is not required but should be done if clinically indicated; HIV patients are excluded because of concerns regarding excess risk of complications of immunosuppressive therapy regimens

    • Known allergy to imidazole drugs such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, sulconazole, tioconazole, or terconazole

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    2 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Thomas E Witzig, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00082888
    Other Study ID Numbers:
    • NCI-2012-02849
    • NCI-2012-02849
    • LS038B
    • LS038B
    • 6246
    • P30CA015083
    • P50CA097274
    First Posted:
    May 19, 2004
    Last Update Posted:
    Apr 13, 2020
    Last Verified:
    Apr 1, 2020
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular
    Lymphoma, Non-Hodgkin
    Hodgkin Disease
    Lymphoma, Mantle-Cell
    Lymphoma, B-Cell, Marginal Zone
    Leukemia, Lymphocytic, Chronic, B-Cell
    Leukemia, T-Cell
    Leukemia-Lymphoma, Adult T-Cell
    Lymphoma, Large-Cell, Anaplastic
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral
    Tipifarnib

    Study Results

    Participant Flow

    Recruitment Details Participants were recruited from 2 medical clinics in the United States between March 2004 to November 2008.
    Pre-assignment Detail
    Arm/Group Title Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group
    Arm/Group Description Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
    Period Title: Overall Study
    STARTED 42 15 36
    COMPLETED 41 15 36
    NOT COMPLETED 1 0 0

    Baseline Characteristics

    Arm/Group Title Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group Total
    Arm/Group Description Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Total of all reporting groups
    Overall Participants 42 15 36 93
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    66.5
    64.0
    48.5
    62
    Sex: Female, Male (Count of Participants)
    Female
    18
    42.9%
    10
    66.7%
    14
    38.9%
    42
    45.2%
    Male
    24
    57.1%
    5
    33.3%
    22
    61.1%
    51
    54.8%

    Outcome Measures

    1. Primary Outcome
    Title Proportion of Participants With Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment
    Description Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
    Time Frame During the first 6 cycles of treatment

    Outcome Measure Data

    Analysis Population Description
    All participants are included in this analysis.
    Arm/Group Title Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group
    Arm/Group Description Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
    Measure Participants 42 15 36
    Number [Proportion of participants]
    0.17
    0.4%
    0.07
    0.5%
    0.31
    0.9%
    2. Secondary Outcome
    Title Overall Survival
    Description Overall survival time was defined as the time from registration to the date of death or last follow-up.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants are included in this analysis.
    Arm/Group Title Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group
    Arm/Group Description Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
    Measure Participants 42 15 36
    Median (95% Confidence Interval) [months]
    6.4
    20.6
    19.7
    3. Secondary Outcome
    Title Time to Progression
    Description Time to progression was defined as the number of months from registration to the date of disease progression with patients being progression-free being censored on the date of their last evaluation. Progression is defined as ≥50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or nonresponders or appearance of any new lesion during or at the end of therapy.
    Time Frame up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group
    Arm/Group Description Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
    Measure Participants 42 15 36
    Median (95% Confidence Interval) [months]
    2.8
    5.2
    3.2
    4. Secondary Outcome
    Title Duration of Response
    Description Duration of response is defined for all evaluable patients that have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression (PD) is documented. CR:Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy PR:≥50% decrease in SPD of the six largest dominant nodes or nodal masses. PD:≥50 % increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders or appearance of any new lesion during or at the end of therapy.
    Time Frame up to 2 years

    Outcome Measure Data

    Analysis Population Description
    Patients who had a response were included in this analysis.
    Arm/Group Title Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group
    Arm/Group Description Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
    Measure Participants 7 1 11
    Median (95% Confidence Interval) [months]
    11.3
    2
    7.5
    5. Secondary Outcome
    Title Number of Patients Who Experienced Grade 3 or 4 Toxicities
    Description Number of patients that experienced a grade 3 or 4 toxicity (adverse events considered at least possibly related to Tipifarnib) as measured by NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL(Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.). Grade 4: Life-threatening consequences; urgent intervention indicated.
    Time Frame Up to 56 days

    Outcome Measure Data

    Analysis Population Description
    Only eligible participants are included in this analysis.
    Arm/Group Title Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group
    Arm/Group Description Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
    Measure Participants 41 15 36
    Count of Participants [Participants]
    32
    76.2%
    8
    53.3%
    24
    66.7%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Only eligible participants are included in this analysis.
    Arm/Group Title Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group
    Arm/Group Description Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion. Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
    All Cause Mortality
    Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 34/41 (82.9%) 9/15 (60%) 27/36 (75%)
    Serious Adverse Events
    Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 27/41 (65.9%) 4/15 (26.7%) 20/36 (55.6%)
    Blood and lymphatic system disorders
    Febrile neutropenia 3/41 (7.3%) 3 0/15 (0%) 0 2/36 (5.6%) 2
    Hemoglobin decreased 2/41 (4.9%) 2 0/15 (0%) 0 2/36 (5.6%) 2
    Gastrointestinal disorders
    Abdominal pain 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Colonic perforation 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Diarrhea 2/41 (4.9%) 2 0/15 (0%) 0 1/36 (2.8%) 1
    Gastric ulcer 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Mucositis oral (funct/sympt) 1/41 (2.4%) 1 0/15 (0%) 0 1/36 (2.8%) 1
    Nausea 2/41 (4.9%) 2 0/15 (0%) 0 0/36 (0%) 0
    Vomiting 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    General disorders
    Death NOS 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Disease progression 3/41 (7.3%) 3 0/15 (0%) 0 0/36 (0%) 0
    Fatigue 7/41 (17.1%) 7 0/15 (0%) 0 1/36 (2.8%) 1
    Fever 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Pain 2/41 (4.9%) 2 0/15 (0%) 0 0/36 (0%) 0
    Hepatobiliary disorders
    Cholecystitis 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Infections and infestations
    Bladder infection(unknown ANC) 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Colitis, infectious 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Mucosal infection(gr 3/4 ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Pneumonia(gr 0/1/2 ANC) 0/41 (0%) 0 0/15 (0%) 0 3/36 (8.3%) 3
    Sepsis(gr 0/1/2 ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Sepsis(gr 3/4 ANC) 2/41 (4.9%) 2 0/15 (0%) 0 0/36 (0%) 0
    Sinusitis(gr 0/1/2 ANC) 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Skin infection 0/41 (0%) 0 1/15 (6.7%) 1 1/36 (2.8%) 1
    Soft tissue infection(gr 0/1/2 ANC) 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Upper respiratory infectn(gr 0/1/2 ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Urinary tract infection(gr 0/1/2 ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 3
    Wound infection(gr 0/1/2 ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Wound infection(gr 3/4 ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Investigations
    Alanine aminotransferase increased 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    INR increased 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Leukocyte count decreased 8/41 (19.5%) 8 2/15 (13.3%) 3 7/36 (19.4%) 8
    Lymphocyte count decreased 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Neutrophil count decreased 15/41 (36.6%) 17 3/15 (20%) 4 9/36 (25%) 12
    Platelet count decreased 8/41 (19.5%) 8 4/15 (26.7%) 5 8/36 (22.2%) 11
    Metabolism and nutrition disorders
    Blood bicarbonate decreased 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Dehydration 3/41 (7.3%) 3 0/15 (0%) 0 1/36 (2.8%) 1
    Serum calcium increased 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Serum magnesium decreased 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Serum potassium decreased 2/41 (4.9%) 2 0/15 (0%) 0 0/36 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 2/41 (4.9%) 3 0/15 (0%) 0 1/36 (2.8%) 1
    Bone pain 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor pain 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Nervous system disorders
    Ataxia 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Headache 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Mini mental status examination abnormal 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Peripheral motor neuropathy 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Speech disorder 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Psychiatric disorders
    Confusion 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Renal and urinary disorders
    Hemorrhage urinary tract 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Ureteric obstruction 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 1/41 (2.4%) 1 0/15 (0%) 0 4/36 (11.1%) 5
    Pleuritic pain 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Pneumonitis 1/41 (2.4%) 1 0/15 (0%) 0 1/36 (2.8%) 1
    Skin and subcutaneous tissue disorders
    Urticaria 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Vascular disorders
    Hypotension 4/41 (9.8%) 4 0/15 (0%) 0 0/36 (0%) 0
    Other (Not Including Serious) Adverse Events
    Aggressive B-cell NHL Group Indolent B-cell NHL Group HL/T-cell Lymphoma Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 38/41 (92.7%) 15/15 (100%) 36/36 (100%)
    Blood and lymphatic system disorders
    Febrile neutropenia 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Hemoglobin decreased 32/41 (78%) 121 14/15 (93.3%) 43 26/36 (72.2%) 136
    Cardiac disorders
    Cardiac disorder 1/41 (2.4%) 1 0/15 (0%) 0 1/36 (2.8%) 1
    Palpitations 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Pericardial effusion 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Sinus tachycardia 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Eye disorders
    Flashing vision 1/41 (2.4%) 1 0/15 (0%) 0 1/36 (2.8%) 2
    Vision blurred 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Gastrointestinal disorders
    Abdominal distension 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 3
    Abdominal pain 3/41 (7.3%) 3 0/15 (0%) 0 0/36 (0%) 0
    Ascites 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Cheilitis 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Colitis 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Constipation 1/41 (2.4%) 2 0/15 (0%) 0 0/36 (0%) 0
    Diarrhea 11/41 (26.8%) 16 5/15 (33.3%) 14 12/36 (33.3%) 20
    Dry mouth 1/41 (2.4%) 2 1/15 (6.7%) 3 0/36 (0%) 0
    Dyspepsia 3/41 (7.3%) 3 1/15 (6.7%) 1 1/36 (2.8%) 2
    Dysphagia 2/41 (4.9%) 2 0/15 (0%) 0 0/36 (0%) 0
    Esophagitis 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Flatulence 2/41 (4.9%) 2 0/15 (0%) 0 4/36 (11.1%) 7
    Gastritis 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Gastrointestinal disorder 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Gastrointestinal pain 0/41 (0%) 0 1/15 (6.7%) 2 0/36 (0%) 0
    Mucositis oral (funct/sympt) 1/41 (2.4%) 1 1/15 (6.7%) 1 0/36 (0%) 0
    Nausea 8/41 (19.5%) 10 6/15 (40%) 16 12/36 (33.3%) 18
    Oral hemorrhage 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Oral pain 0/41 (0%) 0 1/15 (6.7%) 2 0/36 (0%) 0
    Periodontal disease 0/41 (0%) 0 1/15 (6.7%) 2 0/36 (0%) 0
    Rectal fistula 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Vomiting 1/41 (2.4%) 1 3/15 (20%) 5 2/36 (5.6%) 3
    General disorders
    Chills 0/41 (0%) 0 0/15 (0%) 0 3/36 (8.3%) 5
    Edema limbs 5/41 (12.2%) 6 1/15 (6.7%) 1 0/36 (0%) 0
    Fatigue 32/41 (78%) 92 14/15 (93.3%) 51 32/36 (88.9%) 188
    Fever 0/41 (0%) 0 0/15 (0%) 0 2/36 (5.6%) 4
    General symptom 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 2
    Localized edema 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Pain 4/41 (9.8%) 5 0/15 (0%) 0 0/36 (0%) 0
    Infections and infestations
    Appendicitis perforated 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Bronchitis(gr 0/1/2 ANC) 0/41 (0%) 0 2/15 (13.3%) 5 1/36 (2.8%) 1
    Catheter related infection(gr 0/1/2 ANC) 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Infection - Neck(unknown ANC) 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Infection(gr 0/1/2 ANC) 1/41 (2.4%) 1 0/15 (0%) 0 3/36 (8.3%) 3
    Mucosal infection(gr 3/4 ANC) 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Paranasal sinus infection(gr 0/1/2 ANC) 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Pleural infection(gr 0/1/2 ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Pneumonia(gr 0/1/2 ANC) 1/41 (2.4%) 1 0/15 (0%) 0 1/36 (2.8%) 1
    Pneumonia(gr 3/4 ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Pneumonia(unknown ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Sepsis(gr 0/1/2 ANC) 0/41 (0%) 0 1/15 (6.7%) 1 1/36 (2.8%) 1
    Sinusitis(gr 0/1/2 ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Sinusitis(gr 3/4 ANC) 1/41 (2.4%) 1 0/15 (0%) 0 2/36 (5.6%) 2
    Sinusitis(unknown ANC) 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Skin infection(unknown ANC) 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Upper respiratory infectn(gr 0/1/2 ANC) 2/41 (4.9%) 2 1/15 (6.7%) 1 1/36 (2.8%) 1
    Urinary tract infection(gr 3/4 ANC) 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Wound infection 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Injury, poisoning and procedural complications
    Bruising 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 4
    Investigations
    Alanine aminotransferase increased 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Alkaline phosphatase increased 8/41 (19.5%) 31 1/15 (6.7%) 6 11/36 (30.6%) 23
    Aspartate aminotransferase increased 14/41 (34.1%) 49 4/15 (26.7%) 9 8/36 (22.2%) 18
    Blood bilirubin increased 5/41 (12.2%) 5 4/15 (26.7%) 10 5/36 (13.9%) 7
    CD4 lymphocytes decreased 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Creatinine increased 12/41 (29.3%) 58 5/15 (33.3%) 16 5/36 (13.9%) 55
    Leukocyte count decreased 21/41 (51.2%) 64 7/15 (46.7%) 24 15/36 (41.7%) 36
    Lymphocyte count decreased 2/41 (4.9%) 4 1/15 (6.7%) 4 1/36 (2.8%) 1
    Neutrophil count decreased 17/41 (41.5%) 42 8/15 (53.3%) 20 15/36 (41.7%) 49
    Platelet count decreased 29/41 (70.7%) 123 8/15 (53.3%) 43 23/36 (63.9%) 137
    Weight gain 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Weight loss 0/41 (0%) 0 2/15 (13.3%) 4 2/36 (5.6%) 3
    Metabolism and nutrition disorders
    Anorexia 4/41 (9.8%) 5 2/15 (13.3%) 6 3/36 (8.3%) 3
    Blood bicarbonate decreased 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Blood glucose increased 1/41 (2.4%) 1 1/15 (6.7%) 2 0/36 (0%) 0
    Dehydration 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Serum albumin decreased 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Serum calcium decreased 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Serum calcium increased 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Serum potassium decreased 7/41 (17.1%) 7 2/15 (13.3%) 2 4/36 (11.1%) 4
    Serum potassium increased 4/41 (9.8%) 5 0/15 (0%) 0 0/36 (0%) 0
    Serum sodium decreased 6/41 (14.6%) 6 0/15 (0%) 0 3/36 (8.3%) 4
    Serum sodium increased 2/41 (4.9%) 2 0/15 (0%) 0 0/36 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/41 (0%) 0 0/15 (0%) 0 3/36 (8.3%) 3
    Chest wall pain 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Muscle weakness 0/41 (0%) 0 1/15 (6.7%) 2 0/36 (0%) 0
    Myalgia 1/41 (2.4%) 3 2/15 (13.3%) 5 0/36 (0%) 0
    Neck pain 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Pain in extremity 1/41 (2.4%) 2 0/15 (0%) 0 0/36 (0%) 0
    Nervous system disorders
    Ataxia 4/41 (9.8%) 8 2/15 (13.3%) 3 3/36 (8.3%) 3
    Dizziness 2/41 (4.9%) 2 3/15 (20%) 4 2/36 (5.6%) 4
    Dysgeusia 0/41 (0%) 0 1/15 (6.7%) 3 0/36 (0%) 0
    Extrapyramidal disorder 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Headache 2/41 (4.9%) 2 3/15 (20%) 3 1/36 (2.8%) 1
    Neurological disorder NOS 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Peripheral motor neuropathy 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Peripheral sensory neuropathy 16/41 (39%) 72 6/15 (40%) 12 11/36 (30.6%) 134
    Tremor 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 2
    Psychiatric disorders
    Anxiety 2/41 (4.9%) 2 3/15 (20%) 6 1/36 (2.8%) 1
    Confusion 4/41 (9.8%) 4 1/15 (6.7%) 1 2/36 (5.6%) 2
    Depression 0/41 (0%) 0 3/15 (20%) 6 1/36 (2.8%) 3
    Insomnia 1/41 (2.4%) 1 1/15 (6.7%) 2 2/36 (5.6%) 2
    Libido decreased 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Renal and urinary disorders
    Urinary frequency 1/41 (2.4%) 1 0/15 (0%) 0 1/36 (2.8%) 1
    Urine discoloration 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Urogenital disorder 0/41 (0%) 0 1/15 (6.7%) 2 0/36 (0%) 0
    Reproductive system and breast disorders
    Pelvic pain 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Respiratory, thoracic and mediastinal disorders
    Adult respiratory distress syndrome 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Cough 1/41 (2.4%) 1 0/15 (0%) 0 3/36 (8.3%) 4
    Dyspnea 4/41 (9.8%) 5 3/15 (20%) 3 3/36 (8.3%) 5
    Epistaxis 0/41 (0%) 0 2/15 (13.3%) 3 0/36 (0%) 0
    Pleural effusion 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 1
    Respiratory disorder 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Skin and subcutaneous tissue disorders
    Alopecia 2/41 (4.9%) 3 0/15 (0%) 0 0/36 (0%) 0
    Dry skin 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 13
    Photosensitivity 0/41 (0%) 0 0/15 (0%) 0 3/36 (8.3%) 18
    Pruritus 0/41 (0%) 0 0/15 (0%) 0 3/36 (8.3%) 4
    Rash acneiform 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Rash desquamating 10/41 (24.4%) 22 2/15 (13.3%) 4 13/36 (36.1%) 55
    Skin disorder 1/41 (2.4%) 2 0/15 (0%) 0 1/36 (2.8%) 1
    Skin ulceration 1/41 (2.4%) 1 0/15 (0%) 0 0/36 (0%) 0
    Sweating 0/41 (0%) 0 0/15 (0%) 0 2/36 (5.6%) 3
    Vascular disorders
    Hemorrhage 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0
    Hot flashes 0/41 (0%) 0 0/15 (0%) 0 1/36 (2.8%) 12
    Hypotension 0/41 (0%) 0 1/15 (6.7%) 1 0/36 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Thomas E. Witzig, M.D.
    Organization Mayo Clinic
    Phone 507-266-2040
    Email witzig@mayo.edu
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00082888
    Other Study ID Numbers:
    • NCI-2012-02849
    • NCI-2012-02849
    • LS038B
    • LS038B
    • 6246
    • P30CA015083
    • P50CA097274
    First Posted:
    May 19, 2004
    Last Update Posted:
    Apr 13, 2020
    Last Verified:
    Apr 1, 2020