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

March 4, 2015 updated by: Fred Hutchinson Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Time to disease progression
Relapse rates
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Leona A. Holmberg, MD, PhD, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Study Registration Dates

First Submitted

January 30, 2009

First Submitted That Met QC Criteria

January 30, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2150.00
  • P30CA015704 (U.S. NIH Grant/Contract)
  • FHCRC-2150.00
  • IR-6846
  • CDR0000633628 (Registry Identifier: PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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