Study on Early Genetic Changes During Venetoclax Treatment for Difficult or Returning Chronic Lymphocytic Leukemia (CLL)

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03986034

Provider View

This clinical trial is exploring how the drug venetoclax affects cancer cells and the immune system in patients with chronic lymphocytic leukemia (CLL) that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to understand the genetic changes that occur in cancer cells and the immune system during treatment with venetoclax in patients with chronic lymphocytic leukemia (CLL) that has come back or is not responding to other treatments. Participants will start with a low dose of venetoclax, which will be gradually increased to find the best dose for them. The study will last at least two years, and participants will have regular health check-ups, including blood tests, CT scans, and bone marrow biopsies.

Description

This study aims to explore how venetoclax, a drug used to treat chronic lymphocytic leukemia (CLL), affects cancer cells and the immune system. Participants will start with a low dose of venetoclax, which will be increased weekly until the best dose is found, usually over about five weeks. During this time, participants will visit the NIH weekly for health checks and may need to stay in the hospital for observation. After this initial phase, participants will continue treatment with their local cancer doctor and visit the NIH every six months or if their condition changes. The study will include regular health assessments, blood tests, CT scans, and bone marrow biopsies to monitor the effects of the treatment. The study will last at least two years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Have active disease, which may include significant weight loss, extreme fatigue, fevers, night sweats, or worsening blood cell counts.
  • Have a hematologist/oncologist who will continue care after the initial treatment phase.
  • Be 18 years or older.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Agree to use contraception during treatment if sexually active and able to have children.
  • Willing to participate in all study evaluations and procedures, including taking capsules.
  • Able to understand the study and provide informed consent.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have an uncontrolled active infection.
  • Have a life-threatening illness or medical condition that could affect safety or study outcomes.
  • Have another progressing cancer that requires treatment, except for certain skin cancers or cervical cancer that has been treated.
  • Have had Richter's Transformation.
  • Have previously used BCL-2 inhibitors.
  • Are using strong CYP3A4 inhibitors.
  • Have a disease affecting digestion or absorption.
  • Have uncontrolled autoimmune blood disorders.
  • Are receiving other cancer treatments.
  • Have very low blood cell counts or high bilirubin levels.
  • Have severe psychiatric or cognitive issues that affect study participation.

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