search
Back to results

S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment

Primary Purpose

Leukemia

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
rituximab
bendamustine hydrochloride
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Histologically and immunophenotypically confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)

    • Progressive or symptomatic disease
    • Purine analog-refractory disease

  • Must meet 1 of the following criteria:

    • Intermediate- or high-risk modified-Rai stage
    • Low-risk modified-Rai stage and progressive lymphocytosis, defined as > 50% increase of absolute peripheral lymphocyte count over the lowest count during the past 2 months
  • Received 1 or more prior therapies for CLL
  • Must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients"

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-3
  • ANC > 1,000/mm³
  • Platelet count > 50,000/mm³
  • Serum creatinine ≤ 2 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No systemic fungal, bacterial, viral, or other infection that is not controlled (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
  • No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 5 years

  • HIV positivity allowed provided the following criteria are met:

    • CD4 cells > 350/mm³
    • No concurrent antiretroviral therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 28 days since prior chemotherapy, any other investigational agents, or major surgery

  • More than 120 days since prior allogeneic or autologous hematopoietic stem cell transplantation

    • If prior allogeneic bone marrow transplantation, must meet the following criteria:

      • Performed > 120 days ago
      • No acute graft-vs-host disease (GVHD) ≥ grade 2
      • Receiving no immunosuppressive therapy for chronic GVHD
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent CYP1A2 inhibitors

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Response rate (CR, CRi, or PR)
    Safety and tolerability

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2009
    Last Updated
    March 5, 2015
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00939328
    Brief Title
    S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment
    Official Title
    S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    question was no longer committee priority
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as bendamustine, 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, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Giving bendamustine together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of giving bendamustine together with rituximab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia that has not responded to previous treatment.
    Detailed Description
    OBJECTIVES: To test whether the response rate (CR, CRi, or PR) in patients with purine analog-refractory, B-cell chronic lymphocytic leukemia (CLL) after treatment with the combination of bendamustine hydrochloride and rituximab is sufficiently high to warrant further investigation. To evaluate the safety and tolerability of bendamustine hydrochloride and rituximab in patients with B-cell CLL who are refractory to treatment with a purine-nucleoside analog-containing regimen. To investigate, in a preliminary manner, the prognostic effects of pre-treatment cytogenetic abnormalities identified by conventional cytogenetics and by FISH analyses on response to treatment in this patient population. OUTLINE: This is a multicenter study. Patients receive rituximab IV on day 1 and bendamustine IV over 30 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. In course 1 only, patients also receive rituximab IV on day 2. After completion of study treatment, patients are followed up periodically for 2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia
    Keywords
    B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    rituximab
    Intervention Type
    Drug
    Intervention Name(s)
    bendamustine hydrochloride
    Primary Outcome Measure Information:
    Title
    Response rate (CR, CRi, or PR)
    Title
    Safety and tolerability

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically and immunophenotypically confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) Progressive or symptomatic disease Purine analog-refractory disease Must meet 1 of the following criteria: Intermediate- or high-risk modified-Rai stage Low-risk modified-Rai stage and progressive lymphocytosis, defined as > 50% increase of absolute peripheral lymphocyte count over the lowest count during the past 2 months Received 1 or more prior therapies for CLL Must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients" PATIENT CHARACTERISTICS: Zubrod performance status 0-3 ANC > 1,000/mm³ Platelet count > 50,000/mm³ Serum creatinine ≤ 2 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min Not pregnant or nursing Fertile patients must use effective contraception No systemic fungal, bacterial, viral, or other infection that is not controlled (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 5 years HIV positivity allowed provided the following criteria are met: CD4 cells > 350/mm³ No concurrent antiretroviral therapy PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 28 days since prior chemotherapy, any other investigational agents, or major surgery More than 120 days since prior allogeneic or autologous hematopoietic stem cell transplantation If prior allogeneic bone marrow transplantation, must meet the following criteria: Performed > 120 days ago No acute graft-vs-host disease (GVHD) ≥ grade 2 Receiving no immunosuppressive therapy for chronic GVHD No concurrent antiretroviral therapy for HIV-positive patients No concurrent CYP1A2 inhibitors
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matt E. Kalaycio, MD
    Organizational Affiliation
    The Cleveland Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment

    We'll reach out to this number within 24 hrs