Study on Ibrutinib With or Without Rituximab for Treating Relapsed Chronic Lymphocytic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02007044

Provider View

This clinical trial is exploring whether the drug ibrutinib, used alone or with rituximab, is more effective in treating patients whose chronic lymphocytic leukemia (CLL) has returned after previous treatment.

Patient Parameters

Program Overview

This study is testing the effectiveness of ibrutinib, a drug that may stop cancer cells from growing, with or without the addition of rituximab, an immunotherapy drug that helps the immune system attack cancer cells. The goal is to see if adding rituximab improves treatment outcomes for patients with chronic lymphocytic leukemia (CLL) that has come back after treatment.

Description

The main goal of this study is to compare how long patients live without their cancer getting worse over a two-year period when treated with ibrutinib alone versus ibrutinib combined with rituximab. Researchers will also look at the safety of these treatments, how well patients respond, and changes in immune system markers.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will take ibrutinib by mouth every day in 28-day cycles, continuing as long as the treatment is effective and side effects are manageable.
  • Group 2: Will take ibrutinib in the same way as Group 1, but will also receive rituximab through an IV on specific days during the first six cycles.

After finishing the treatment, participants will have follow-up visits at 60 days and then every four months for five years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have been diagnosed with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic leukemia (PLL) and have received previous treatment.
  • Patients with certain genetic markers (17p deletion or TP53 mutation) can join even if they haven't been treated before.
  • Must meet specific criteria for needing treatment based on medical guidelines.
  • Must be 18 years or older, able to understand and sign a consent form, and willing to follow study procedures.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Women of childbearing potential must agree to use effective birth control during the study and for 30 days after the last dose.
  • Must have acceptable liver and kidney function based on blood tests.
  • Must not have had other cancers in the past three years, except for certain skin or cervical cancers.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Previous treatment with ibrutinib or similar drugs targeting BTK.
  • Recent treatment with chemotherapy, immunotherapy, or other cancer treatments within 21 days before joining the study.
  • Recent participation in another clinical trial within 30 days before starting the study.
  • Uncontrolled infections or autoimmune conditions affecting blood cells.
  • Severe blood cell deficiencies not related to the disease.
  • Serious heart, kidney, liver, or other organ diseases that could increase risks.
  • Recent heart attack, stroke, or significant bleeding issues.
  • Recent major surgery or serious injuries.
  • Use of the blood thinner Coumadin within seven days before starting the study.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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