Study on Lenalidomide and Rituximab Combination for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT01446133

Provider View

This clinical trial is exploring whether a combination of lenalidomide and rituximab can effectively manage Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study also aims to assess the safety of this drug combination.

Patient Parameters

Program Overview

The purpose of this study is to determine if combining lenalidomide and rituximab can help control CLL or SLL. Lenalidomide works by altering the immune system and may prevent the growth of blood vessels that support tumors, potentially slowing cancer growth. Rituximab attaches to cancer cells, damaging them and possibly causing them to die. The study will also evaluate the safety of using these drugs together.

Description

If you qualify for this study, you will take the study drugs in 28-day cycles. In the first cycle, you will receive rituximab once a week through an IV. In the second cycle, you will not receive rituximab. From the third to the twelfth cycle, you will receive rituximab on the first day of each cycle. The first dose of rituximab will take 6-8 hours to administer, but if you tolerate it well, future doses may take 2-4 hours.

Starting on the ninth day of the first cycle, you will take lenalidomide by mouth once a day. The dose may change based on any side effects. Swallow the capsules whole with a glass of water at the same time each day. If you miss a dose, take it as soon as you remember on the same day, but do not double up the next day.

During the first cycle, you will also take allopurinol once a day for the first 14 days to reduce side effects.

You will have regular study visits. For the first five weeks, you will have weekly blood tests. After that, blood tests will be every two weeks until your lenalidomide dose is stable, then every four weeks. At the end of cycles 3, 6, and 12, and every six cycles after that if you continue, you will have a bone marrow biopsy to check the disease status.

If you can become pregnant, you will have pregnancy tests before starting lenalidomide and regularly during and after treatment.

You may receive rituximab for up to 12 cycles and continue lenalidomide as long as it benefits you. You will stop the study drugs if the disease worsens, side effects are intolerable, or you cannot follow the study directions.

This study is investigational for this drug combination in CLL. Lenalidomide and rituximab are FDA-approved for other uses. Up to 120 patients will participate, all at M. D. Anderson.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to understand and sign informed consent.
  • Have CLL or SLL needing treatment but not suitable for or unwilling to have chemoimmunotherapy, or have previously treated or recurrent CLL/SLL.
  • Have a performance status score of 0-2, indicating good overall health.
  • Have adequate kidney and liver function based on specific blood tests.
  • Be free of other cancers for 3 years, except for certain skin cancers or in situ cancers.
  • Be registered in the RevAssist program and comply with its requirements.
  • Women of childbearing potential must have negative pregnancy tests before and during treatment and agree to use effective birth control. Men must use condoms during sexual contact with women of childbearing potential.

Exclusion Criteria

  • Known allergy to lenalidomide, thalidomide derivatives, or rituximab.
  • Have prolymphocytic leukemia.
  • Test positive for HIV or active hepatitis B or C.
  • Pregnant or breastfeeding women.
  • History of tuberculosis treated in the last five years or recent exposure.
  • Any serious medical or psychiatric condition that poses a risk if participating.
  • Recent history of blood clots in the last six months.

Locations

FACILITYZIPCITYSTATE
University of Texas MD Anderson Cancer Center77030HoustonTexas

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