Study on a New Combination Treatment for Patients with Untreated Chronic Lymphocytic Leukemia or Richter Transformation

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05536349

Provider View

This clinical trial is testing a new combination of three drugs—pirtobrutinib, venetoclax, and obinutuzumab—to see if they are safe and effective for patients with chronic lymphocytic leukemia (CLL) or Richter transformation (RT) who have not received treatment before.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of three drugs—pirtobrutinib, venetoclax, and obinutuzumab—can safely and effectively treat patients with chronic lymphocytic leukemia (CLL) or Richter transformation (RT) who have not been treated before. Researchers will look at how well the treatment works in reducing cancer cells and how safe it is for patients.

Description

The main goal of this study is to see how well the combination of pirtobrutinib, venetoclax, and obinutuzumab works in treating patients with untreated chronic lymphocytic leukemia (CLL) or Richter transformation (RT). Researchers will measure the treatment's effectiveness by checking for undetectable levels of cancer cells in the blood and bone marrow. They will also look at the overall response rate in patients with RT.

Secondary goals include evaluating the overall response rate, progression-free survival, and overall survival of patients. The study will also assess the safety and tolerability of the treatment.

Additionally, researchers will explore changes in the immune system and cancer cells in response to the treatment and monitor how quickly cancer cells decrease over time.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with untreated chronic lymphocytic leukemia (CLL) or Richter transformation (RT).
  • Good overall health with a performance status score of 0 to 2.
  • Adequate liver and kidney function based on specific blood tests.
  • Sufficient blood cell counts, including platelets and hemoglobin levels.
  • Ability to swallow tablets and follow the study's treatment and monitoring schedule.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for six months after the last dose. Men must also agree to use contraception during the study and for six months after.

Exclusion Criteria

  • Major surgery within four weeks before starting the study.
  • Uncontrolled active infections or known HIV infection.
  • Active hepatitis B or C infection.
  • Active cytomegalovirus (CMV) infection.
  • Uncontrolled autoimmune conditions requiring high-dose steroids.
  • Significant heart disease or recent heart attack, stroke, or bleeding.
  • Prolonged QT interval on an ECG.
  • Pregnancy or breastfeeding.
  • Use of certain medications that affect the liver or heart.
  • Known central nervous system involvement by CLL/SLL/RT.
  • Active second cancer unless in remission with a life expectancy over two years.
  • Prior treatment restrictions, including certain therapies for CLL/SLL or RT.
  • Known allergies to study drugs or conditions affecting drug absorption.
  • Recent live-virus vaccinations.

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