Active — Not RecruitingPhase 3

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)

United States, Belgium211 participantsStarted 2018-04-17

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Cumulative Illness Rating Scale (CIRS) score \> 6
✓. Creatinine clearance (CrCl) estimated less than (\<) 70 milliliter per minute (mL/min) using Cockcroft-Gault equation

What they're measuring

Progression Free Survival (PFS)

Timeframe: Up to 2 years 10 months

Trial details

NCT IDNCT03462719

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-26

Results submitted2022-02-25

View on ClinicalTrials.gov More Leukemia, Lymphocytic, Chronic, B-Cell trials