Study Comparing Ibrutinib and Venetoclax with Chlorambucil and Obinutuzumab for Initial Treatment of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT03462719

This clinical trial is evaluating two different treatment combinations to see which is more effective in preventing the progression of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) in patients who have not received treatment before.

Patient Parameters

Program Overview

The aim of this study is to compare the effectiveness of two treatment combinations for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). One group will receive Ibrutinib and Venetoclax, while the other group will receive Obinutuzumab and Chlorambucil. The study will measure how long patients live without their disease getting worse.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 65 or older, or adults aged 18 to 64 with certain health conditions:
    • A Cumulative Illness Rating Scale (CIRS) score greater than 6
    • Reduced kidney function with creatinine clearance less than 70 mL/min
  • Diagnosed with CLL or SLL according to specific medical criteria
  • Have at least one lymph node larger than 1.5 cm as seen on a CT scan
  • Be in relatively good health with an ECOG performance status of 0 to 2
  • Have active CLL/SLL that requires treatment

Exclusion Criteria

  • Have received previous treatment for CLL or SLL
  • Have a specific genetic abnormality (del17p) or TP53 mutation in more than 10% of cells
  • Have had major surgery within 4 weeks before starting the study treatment
  • Have known bleeding disorders like von Willebrand's disease or hemophilia
  • Have cancer that has spread to the brain or suspect a transformation to a more aggressive form of lymphoma (Richter's syndrome)

Locations

FACILITYZIPCITYSTATE
Norton Cancer Institute40207LouisvilleKentucky
John Theurer Cancer Center07601HackensackNew Jersey
Novant Health28204CharlotteNorth Carolina

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