Study on the Combination of Venetoclax and Obinutuzumab for Treating Chronic Lymphocytic Leukemia (CLL)

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT04447768

This clinical trial is exploring how effective the combination of two drugs, venetoclax and obinutuzumab, is in treating people with Chronic Lymphocytic Leukemia (CLL) who have not yet received any treatment for their cancer.

Patient Parameters

Program Overview

The purpose of this study is to gather more information on how well the combination of venetoclax and obinutuzumab works in treating Chronic Lymphocytic Leukemia (CLL) in patients who have not previously been treated for their cancer. Researchers aim to understand the effectiveness of this drug combination in managing CLL.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of untreated Chronic Lymphocytic Leukemia (CLL).
  • Need treatment for CLL according to specific guidelines.
  • Have a CIRS score of 6 or less (excluding CLL diagnosis).
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate blood cell counts and organ function, unless affected by CLL.
  • Women of childbearing potential must agree to use effective contraception during treatment and for a specified period after.
  • Men must agree to use contraception and refrain from donating sperm during treatment and for a specified period after.

Exclusion Criteria

  • Have received any prior treatment for CLL, except for a short course of steroids.
  • Have a transformation of CLL to a more aggressive form of cancer.
  • Have allergies to any of the study drugs.
  • Have a history of other cancers, unless treated and in remission for at least 2 years.
  • Have active infections or recent major infections requiring hospitalization.
  • Require the use of certain medications that may interact with the study drugs.
  • Have significant liver disease or active hepatitis.
  • Have a positive test for hepatitis B or C, or HIV.
  • Have received live vaccines recently or need them during the study.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have had recent major surgery.
  • Have difficulty swallowing pills or conditions affecting digestion.
  • Have known allergies to specific medications used to manage side effects.

Locations

FACILITYZIPCITYSTATE
Stanford University Medical Center (Data collection only)94305-5408StanfordCalifornia
Memorial Sloan Kettering Basking Ridge (All protocol activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (All protocol activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Commack (All protocol activities)11725CommackNew York
Memorial Sloan Kettering Westchester (All protocol activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (All protocol activities)11553UniondaleNew York
University of North Carolina27514Chapel HillNorth Carolina

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