Study on Zanubrutinib and Venetoclax as Initial Treatment for Chronic Lymphocytic Leukemia with Response-based Obinutuzumab

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05650723

Provider View

This clinical trial is testing a new approach to treating chronic lymphocytic leukemia (CLL) by using two oral medications, zanubrutinib and venetoclax, and adding a third drug, obinutuzumab, only if needed. The goal is to reduce side effects and improve treatment effectiveness by tailoring therapy based on individual patient response.

Patient Parameters

Program Overview

This study is exploring a new treatment strategy for chronic lymphocytic leukemia (CLL) that starts with two oral medications, zanubrutinib and venetoclax. The idea is to add a third drug, obinutuzumab, only for patients who still have detectable cancer cells after the initial treatment. This approach aims to minimize unnecessary treatment and side effects while increasing the chances of eliminating cancer cells.

Description

This clinical trial involves 50 participants with chronic lymphocytic leukemia (CLL) who need treatment. The study tests whether starting with two oral drugs, zanubrutinib and venetoclax, and adding a third drug, obinutuzumab, only if needed, can effectively treat CLL while reducing side effects.

Participants will first receive zanubrutinib alone for three cycles to reduce the risk of tumor lysis, a condition where cancer cells break down too quickly. After this, they will take both zanubrutinib and venetoclax for 13 cycles. If, after these cycles, cancer cells are not detectable in the blood and bone marrow, participants will stop treatment and be monitored every three months. If cancer cells are still present, participants will continue with the two drugs and add obinutuzumab for six more cycles to try to eliminate the remaining cancer cells.

The study aims to find out if this tailored approach can effectively treat CLL while minimizing unnecessary treatment and side effects.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
  • Must have a medical need for treatment.
  • Participants who can become pregnant must agree to use birth control methods during the study.

Exclusion Criteria

  • Have received any previous treatment for CLL/SLL, including chemotherapy, immunotherapy, or other cancer treatments.
  • Have a history of other cancers, except for certain skin cancers, unless treated and cancer-free for at least five years.
  • Require ongoing immunosuppressive therapy or have used it within six months before the study.
  • Have active autoimmune blood disorders.
  • Have certain types of leukemia or transformation of CLL.
  • Have active bleeding disorders or require blood thinners like warfarin.
  • Have uncontrolled infections or a history of a specific brain infection (PML).
  • Have had a heart attack within six months or unstable heart conditions.
  • Have severe heart failure or certain heart rhythm problems.
  • Have had a stroke or brain bleeding within six months.
  • Are pregnant or breastfeeding.
  • Have had major surgery within 28 days before starting the study.
  • Have difficulty swallowing pills or have digestive issues affecting medication absorption.
  • Are HIV positive.
  • Have allergies to obinutuzumab or its ingredients.
  • Have received a live vaccine within 28 days before starting treatment.

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