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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

This study has been withdrawn prior to enrollment.
(No patient enrolled on study. Did not get patients in timely fashion. All referrals for study when assessed were not eligible.)
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00833534
First received: January 30, 2009
Last updated: July 1, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Biological: rituximab
Drug: lenalidomide
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy [ Designated as safety issue: No ]
  • Disease-free survival at 2 years after transplant [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity during consolidation and maintenance therapy as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Ability to complete planned therapy [ Designated as safety issue: No ]
  • Complete hematological remission, including bone marrow IgH remission status as assessed by PCR after consolidation and maintenance therapy [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Relapse rates [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2009
Arms Assigned Interventions
Experimental: Group I (consolidation phase)
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.
Drug: lenalidomide
Given orally
Experimental: Group II (consolidation phase)
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.
Biological: rituximab
Given IV
Drug: lenalidomide
Given orally

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833534

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Leona A. Holmberg, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Leona A. Holmberg, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00833534     History of Changes
Other Study ID Numbers: 2150.00, P30CA015704, FHCRC-2150.00, IR-6846, CDR0000633628
Study First Received: January 30, 2009
Last Updated: July 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Fred Hutchinson Cancer Research Center:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Rituximab
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Antirheumatic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014