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Lenalidomide With or Without Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Undergone Autologous or Syngeneic Stem Cell Transplant

Primary Purpose

Leukemia, Lymphoma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
rituximab
lenalidomide
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II small lymphocytic lymphoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

    • Any stage disease
  • Prior histological documentation of CD20+ CLL or SLL

  • Has undergone autologous or syngeneic stem cell transplantation comprising high-dose therapy with peripheral blood stem cell rescue within the past 30-120 days

    • No progressive disease after transplantation

      • Has had stable disease or some degree of response to transplantation
  • No history of CNS involvement

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Platelet count ≥ 50,000/mm³* (transfusion independent)
  • ANC ≥ 1,500/mm³*
  • Total bilirubin ≤ 2 mg/mL (unless due to Gilbert's disease)
  • SGOT/SGPT ≤ 2.5 times upper limit of normal
  • Serum creatinine ≤ 2 mg/mL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective methods of contraception for at least 28 days before, during, and for at least 28 days after completion of study therapy
  • Patients and their physician must be registered in the RevAssist® program and be willing and able to comply with the requirements of RevAssist®
  • LVEF ≥ 45% immediately prior to transplant
  • No uncontrolled congestive heart disease
  • No history of myocardial infarction or coronary artery disease
  • No peripheral neuropathy ≥ grade 3
  • No allergy to lenalidomide, thalidomide, allopurinol, or rituximab
  • No known hepatitis B, hepatitis C, or HIV seropositivity
  • No other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
  • No concurrent serious uncontrolled medical or psychiatric illness, including serious infection NOTE: *For 5 calendar days after transplant

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior CD34-selected stem cell product
  • No chemotherapy or biologic therapy for CLL after transplant
  • Prior rituximab administered before stem cell collection allowed
  • Prior lenalidomide administered before transplant allowed provided patient responded to lenalidomide
  • No concurrent sargramostim (GM-CSF)
  • No other concurrent anticancer therapies, including radiotherapy or thalidomide
  • No other concurrent investigational agents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group I (consolidation phase)

    Group II (consolidation phase)

    Arm Description

    Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

    Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.

    Outcomes

    Primary Outcome Measures

    Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy
    Disease-free survival at 2 years after transplant

    Secondary Outcome Measures

    Toxicity during consolidation and maintenance therapy as assessed by NCI CTCAE v3.0
    Ability to complete planned therapy
    Complete hematological remission, including bone marrow IgH remission status as assessed by PCR after consolidation and maintenance therapy
    Time to disease progression
    Relapse rates

    Full Information

    First Posted
    January 30, 2009
    Last Updated
    March 4, 2015
    Sponsor
    Fred Hutchinson Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00833534
    Brief Title
    Lenalidomide With or Without Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Undergone Autologous or Syngeneic Stem Cell Transplant
    Official Title
    Consolidation Therapy With Lenalidomide (Revlimid®) With or Without Rituximab Followed by Maintenance Therapy With Revlimid® After Autologous/Syngeneic Transplant for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No patient enrolled on study. Did not get patients in timely fashion. All referrals for study when assessed were not eligible.
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Fred Hutchinson Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer 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 cancer-killing substances to them. It is not yet known whether lenalidomide is more effective with or without rituximab in treating chronic lymphocytic leukemia or small lymphocytic lymphoma. PURPOSE: This phase II trial is studying how well lenalidomide works when given with or without rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplant.
    Detailed Description
    OBJECTIVES: Primary To evaluate the efficacy of consolidation therapy comprising lenalidomide with or without rituximab followed by maintenance therapy comprising lenalidomide in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplantation. OUTLINE: Consolidation phase: Patients are assigned to 1 of 2 treatment groups. Group I: Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Group II: Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity. Maintenance phase: Beginning 2 months after completion of consolidation therapy, all patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 18 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 28 days and then annually thereafter.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia, Lymphoma
    Keywords
    stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II small lymphocytic lymphoma

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group I (consolidation phase)
    Arm Type
    Experimental
    Arm Description
    Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
    Arm Title
    Group II (consolidation phase)
    Arm Type
    Experimental
    Arm Description
    Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
    Intervention Type
    Biological
    Intervention Name(s)
    rituximab
    Intervention Description
    Given IV
    Intervention Type
    Drug
    Intervention Name(s)
    lenalidomide
    Intervention Description
    Given orally
    Primary Outcome Measure Information:
    Title
    Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy
    Title
    Disease-free survival at 2 years after transplant
    Secondary Outcome Measure Information:
    Title
    Toxicity during consolidation and maintenance therapy as assessed by NCI CTCAE v3.0
    Title
    Ability to complete planned therapy
    Title
    Complete hematological remission, including bone marrow IgH remission status as assessed by PCR after consolidation and maintenance therapy
    Title
    Time to disease progression
    Title
    Relapse rates

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Any stage disease Prior histological documentation of CD20+ CLL or SLL Has undergone autologous or syngeneic stem cell transplantation comprising high-dose therapy with peripheral blood stem cell rescue within the past 30-120 days No progressive disease after transplantation Has had stable disease or some degree of response to transplantation No history of CNS involvement PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Platelet count ≥ 50,000/mm³* (transfusion independent) ANC ≥ 1,500/mm³* Total bilirubin ≤ 2 mg/mL (unless due to Gilbert's disease) SGOT/SGPT ≤ 2.5 times upper limit of normal Serum creatinine ≤ 2 mg/mL Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 effective methods of contraception for at least 28 days before, during, and for at least 28 days after completion of study therapy Patients and their physician must be registered in the RevAssist® program and be willing and able to comply with the requirements of RevAssist® LVEF ≥ 45% immediately prior to transplant No uncontrolled congestive heart disease No history of myocardial infarction or coronary artery disease No peripheral neuropathy ≥ grade 3 No allergy to lenalidomide, thalidomide, allopurinol, or rituximab No known hepatitis B, hepatitis C, or HIV seropositivity No other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast No concurrent serious uncontrolled medical or psychiatric illness, including serious infection NOTE: *For 5 calendar days after transplant PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior CD34-selected stem cell product No chemotherapy or biologic therapy for CLL after transplant Prior rituximab administered before stem cell collection allowed Prior lenalidomide administered before transplant allowed provided patient responded to lenalidomide No concurrent sargramostim (GM-CSF) No other concurrent anticancer therapies, including radiotherapy or thalidomide No other concurrent investigational agents
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leona A. Holmberg, MD, PhD
    Organizational Affiliation
    Fred Hutchinson Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Lenalidomide With or Without Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Undergone Autologous or Syngeneic Stem Cell Transplant

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