A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Official Title

A Randomized, Open-label, Phase 3 Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Subjects With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

Summary:

The purpose of this study is to assess progression‑free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).

Trial Description

Primary Outcome:

  • Progression-Free Survival (PFS)
Secondary Outcome:
  • Percentage of Participants who are Minimal Residual Disease (MRD) Negative
  • Overall Response Rate (ORR)
  • Complete Response (CR) Rate
  • Duration of Response (DOR)
  • Overall Survival (OS)
  • Time-to-Next Treatment
  • Time to Worsening as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score
  • Time to Worsening as Measured by Using EuroQol 5 Dimension 5 Level questionnaire (EQ-5D 5L)
  • Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
  • Number of Participants with Abnormal Clinical Laboratory Findings
  • Percentage of Participants with Sustained Hemoglobin Improvement
  • Percentage of Participants with Sustained Platelet Improvement
  • Concentration at End of Dosing Interval (24h) at Steady-state (Ctrough, ss)
The hypothesis is treatment with combination of I+VEN will result in longer PFS compared with G-Clb in participants with previously untreated chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) who meet International Workshop on CLL (iwCLL) treatment criteria. The study includes screening (30 days), treatment (from randomization until treatment discontinuation) and follow-up phase (from treatment discontinuation until death, lost to follow up, consent withdrawal, or study end, whichever occurs first). Participants without progression will continue disease evaluations until disease progression or death. Study duration is approximately 6 years. Safety includes review of adverse events and laboratory tests performed over time.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society