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Rituximab and Cladribine in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
rituximab
cladribine
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed mantle cell lymphoma* Measurable or assessable disease defined as at least one of the following: Lymph node or tumor mass that is 2.0 cm or more in at least one dimension by CT scan, MRI, or plain radiograph imaging OR greater than 1.5 cm in at least one dimension by physical exam Splenic enlargement, if the spleen is palpable, at least 3 cm below the left costal margin Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs, or bowel by lymphoma without a discrete mass would constitute assessable, but not measurable, disease No known CNS involvement NOTE: *If tumor tissue is unavailable for biopsy, blood or bone marrow specimens may be used to establish patient eligibility provided fusion signals indicate the presence of t(11;14)(q13;q32) by fluorescence in situ hybridization using CCND1/IGH AND mantle cell lymphoma involvement is determined by morphology PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-3 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Total or direct bilirubin no greater than upper limit of normal (ULN) (with or without secondary liver involvement) SGOT no greater than 3 times ULN (5 times ULN if there is liver involvement) Renal Creatinine no greater than 2.0 mg/dL Cardiovascular No myocardial infarction within the past 6 months No uncontrolled high blood pressure No unstable angina No serious uncontrolled cardiac arrhythmia No active congestive heart failure Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 30 days after study participation HIV negative No other malignancy within the past 5 years except carcinoma in situ of the cervix, resected basal cell or squamous cell skin cancer, or prostate cancer that is in remission after a radical retropubic prostatectomy or radiotherapy No medical or psychiatric condition that makes the patient a poor risk for this study No active or uncontrolled infection No known hypersensitivity to rituximab or its components or to murine proteins PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for mantle cell lymphoma Chemotherapy No prior chemotherapy for mantle cell lymphoma Endocrine therapy No prior endocrine therapy for mantle cell lymphoma Radiotherapy No prior radiotherapy Surgery Prior splenectomy allowed (for diagnosis, cytopenia, or symptomatic splenomegaly)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    rituximab + cladribine

    Arm Description

    Patients receive rituximab IV over 4-8 hours on day 1 and cladribine IV over 2 hours on days 4-8. If 2 or more patients experience unacceptable toxicity during the first course, the study is discontinued; otherwise, the study is opened for enrollment at all NCCTG sites. Treatment repeats every 28 days for a total of 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.

    Outcomes

    Primary Outcome Measures

    Complete remission (CR) and complete remission unconfirmed (CRu) rate at the close of study therapy assessment (after 2, 4, or 6 courses)

    Secondary Outcome Measures

    Progression at any time after therapy

    Full Information

    First Posted
    January 27, 2003
    Last Updated
    December 5, 2016
    Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00053027
    Brief Title
    Rituximab and Cladribine in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
    Official Title
    Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA) in Newly Diagnosed Mantle Cell Lymphoma (MCL)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2003 (undefined)
    Primary Completion Date
    January 2006 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as cladribine work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with cladribine may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with cladribine works in treating patients with newly-diagnosed mantle cell lymphoma.
    Detailed Description
    OBJECTIVES: Determine whether rituximab and cladribine will increase the complete remission rate and the unconfirmed complete remission rate in patients with mantle cell lymphoma. Determine the time to progression in patients treated with this regimen. Determine the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. An initial cohort of 6 patients at Mayo Clinic receives rituximab IV over 4-8 hours on day 1 and cladribine IV over 2 hours on days 4-8. If 2 or more patients experience unacceptable toxicity during the first course, the study is discontinued; otherwise, the study is opened for enrollment at all NCCTG sites. (The phase II study is open for enrollment as of 5/14/04.) Treatment repeats every 28 days for a total of 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma
    Keywords
    contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    rituximab + cladribine
    Arm Type
    Experimental
    Arm Description
    Patients receive rituximab IV over 4-8 hours on day 1 and cladribine IV over 2 hours on days 4-8. If 2 or more patients experience unacceptable toxicity during the first course, the study is discontinued; otherwise, the study is opened for enrollment at all NCCTG sites. Treatment repeats every 28 days for a total of 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.
    Intervention Type
    Biological
    Intervention Name(s)
    rituximab
    Intervention Type
    Drug
    Intervention Name(s)
    cladribine
    Primary Outcome Measure Information:
    Title
    Complete remission (CR) and complete remission unconfirmed (CRu) rate at the close of study therapy assessment (after 2, 4, or 6 courses)
    Time Frame
    Up to 4 years
    Secondary Outcome Measure Information:
    Title
    Progression at any time after therapy
    Time Frame
    Up to 4 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed mantle cell lymphoma* Measurable or assessable disease defined as at least one of the following: Lymph node or tumor mass that is 2.0 cm or more in at least one dimension by CT scan, MRI, or plain radiograph imaging OR greater than 1.5 cm in at least one dimension by physical exam Splenic enlargement, if the spleen is palpable, at least 3 cm below the left costal margin Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs, or bowel by lymphoma without a discrete mass would constitute assessable, but not measurable, disease No known CNS involvement NOTE: *If tumor tissue is unavailable for biopsy, blood or bone marrow specimens may be used to establish patient eligibility provided fusion signals indicate the presence of t(11;14)(q13;q32) by fluorescence in situ hybridization using CCND1/IGH AND mantle cell lymphoma involvement is determined by morphology PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-3 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Total or direct bilirubin no greater than upper limit of normal (ULN) (with or without secondary liver involvement) SGOT no greater than 3 times ULN (5 times ULN if there is liver involvement) Renal Creatinine no greater than 2.0 mg/dL Cardiovascular No myocardial infarction within the past 6 months No uncontrolled high blood pressure No unstable angina No serious uncontrolled cardiac arrhythmia No active congestive heart failure Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 30 days after study participation HIV negative No other malignancy within the past 5 years except carcinoma in situ of the cervix, resected basal cell or squamous cell skin cancer, or prostate cancer that is in remission after a radical retropubic prostatectomy or radiotherapy No medical or psychiatric condition that makes the patient a poor risk for this study No active or uncontrolled infection No known hypersensitivity to rituximab or its components or to murine proteins PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for mantle cell lymphoma Chemotherapy No prior chemotherapy for mantle cell lymphoma Endocrine therapy No prior endocrine therapy for mantle cell lymphoma Radiotherapy No prior radiotherapy Surgery Prior splenectomy allowed (for diagnosis, cytopenia, or symptomatic splenomegaly)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David J. Inwards, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18470909
    Citation
    Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer. 2008 Jul 1;113(1):108-16. doi: 10.1002/cncr.23537.
    Results Reference
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    Rituximab and Cladribine in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma

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