Study Comparing Intermittent and Continuous Venetoclax with Acalabrutinib for Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Sponsor: Zulfa Omer

Sponsor score: 0

ClinicalTrials ID:NCT07014917

Provider View

This clinical trial is testing two different ways of giving the drug venetoclax, either intermittently or continuously, along with acalabrutinib, to see which method is more effective for patients with untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

Patient Parameters

Program Overview

The study aims to find out if taking venetoclax intermittently (7 days per cycle) or continuously (28 days per cycle) with acalabrutinib is more effective in treating patients with CLL or SLL who have not received treatment before. Researchers will monitor the effectiveness and safety of both methods to determine which approach works better in reducing cancer cells.

Description

This clinical trial involves two groups of patients with untreated CLL or SLL. One group will receive venetoclax intermittently, while the other will receive it continuously, both in combination with acalabrutinib. The study will help determine which method is more effective in treating these types of cancer. Researchers will also monitor any side effects to ensure the treatment is safe. The trial will use a specific design to evaluate the effectiveness of the treatments and decide if a larger study is needed. Participants will be closely monitored for any adverse effects, and the study will be stopped if the side effects are too severe.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and have not received treatment before.
  • Aged 18 years or older.
  • In good general health with a performance status score of 0, 1, or 2.
  • Have adequate organ and bone marrow function based on specific blood test results.
  • Women who can become pregnant must use effective birth control during the study and for 2 days after the last dose of acalabrutinib.
  • Men must use effective birth control and agree not to donate sperm during the study.
  • Willing to participate in all study procedures and able to swallow tablets.
  • Understand the study and provide informed consent.

Exclusion Criteria

  • Have any active disease or condition that makes participation unsafe or would interfere with the study.
  • Have active Richter's transformation or central nervous system lymphoma.
  • Have received any investigational drug or major surgery recently.
  • Have a history of other cancers that could affect the study, except for certain treated skin cancers or early-stage cancers.
  • Have significant heart disease or other serious medical conditions.
  • Have uncontrolled infections, including HIV or hepatitis B or C.
  • Have had a stroke or significant bleeding issues recently.
  • Are pregnant, breastfeeding, or planning to become pregnant.
  • Are taking certain medications that interfere with the study drugs.
  • Are participating in another clinical trial.

Locations

FACILITYZIPCITYSTATE
University of Cincinnati45219CincinnatiOhio

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