Study on Ibrutinib for Treating Remaining Cancer Cells in Chronic Lymphocytic Leukemia Patients After Initial Treatment

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02649387

Provider View

This clinical trial is testing how well the drug ibrutinib works in patients with chronic lymphocytic leukemia (CLL) who still have some cancer cells left after their first round of treatment. The study aims to see if ibrutinib can help eliminate these remaining cancer cells and how safe it is to use.

Patient Parameters

Program Overview

This study is exploring the effectiveness and safety of ibrutinib in patients with chronic lymphocytic leukemia (CLL) who have responded to their initial treatment but still have some cancer cells left. Ibrutinib works by blocking certain enzymes that cancer cells need to grow. The trial will measure how many patients achieve a state where no cancer cells are detectable in their blood or bone marrow and how long this state lasts. It will also look at the side effects of ibrutinib and how it affects patients' quality of life.

Description

The main goal of this study is to see how many patients with CLL can achieve a state where no cancer cells are detectable (MRD-negative) in their blood or bone marrow while taking ibrutinib. The study will also look at how long it takes to reach this state and how long it lasts. Researchers will monitor the side effects of ibrutinib and how it affects patients' quality of life, including mood and social support.

Participants will take ibrutinib by mouth once a day in cycles of 4 weeks, for up to 36 cycles, unless the disease progresses or side effects become too severe. After finishing the treatment, patients will have follow-up visits every 3-6 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to sign a consent form.
  • Willing to follow the study schedule and provide blood and bone marrow samples.
  • Diagnosed with B-cell chronic lymphocytic leukemia (B-CLL).
  • Completed initial treatment for B-CLL between 56 and 365 days before joining the study.
  • Achieved a partial or complete response to initial treatment but still have some cancer cells present.
  • In good overall health with an ECOG performance status of 0, 1, or 2.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.

Exclusion Criteria

  • Serious medical or psychiatric conditions that prevent participation.
  • Pregnant or nursing women, or those not willing to use contraception.
  • Conditions that pose a high risk if participating in the study.
  • Use of other experimental drugs within 28 days before joining the study.
  • More than one previous treatment for CLL.
  • Progressive disease or relapse before joining the study.
  • History of other cancers unless in remission for over 3 years.
  • Already MRD-negative after initial treatment.
  • Use of certain blood thinners or medications that affect liver function.
  • Recent major surgery or active infectious hepatitis.
  • Other diseases that increase risk with ibrutinib treatment, such as active HIV infection or bleeding disorders.

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