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Study of Venetoclax and Obinutuzumab for Recurring CLL

This study is for adults with chronic lymphocytic leukemia (CLL), a type of blood cancer, that has come back after previous treatment. It is testing a combination of two approved drugs, venetoclax (an oral tablet) and obinutuzumab (given through an IV), to see how well they work and what side effects they cause. You may be able to join if you've already had venetoclax with another anti-CD20 antibody therapy and achieved a good response. The study aims to see how many people respond to this retreatment after 9 months. About 75 people are expected to participate.

Study design
This interventional study will enroll about 75 participants and divide them into two groups (cohorts) based on when their CLL symptoms returned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 9 months after the end of combination treatment, suggesting follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04895436

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~75 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:VenetoclaxObinutuzumab

At a glance

Recruiting sites
50 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response (OR) in Cohort 1 after end of combination treatment
Measured over 9 months

Conditions

Chronic Lymphocytic Leukemia (CLL)

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Chronic Lymphocytic Leukemia

NCT04895436

Where you'd take part

This study runs at 58 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504

    Turin, Piedmont, Italyno site contact published

    Recruiting

  • Azienda Ospedaliera Santa Maria Terni /ID# 229442

    Terni, Italyno site contact published

    Recruiting

  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168

    Dresden, Saxony, Germanyno site contact published

    Recruiting

  • Blackpool Victoria Hospital /ID# 267280

    Blackpool, Lancashire, United Kingdomno site contact published

    Recruiting

  • Bruederkrankenhaus St. Josef Paderborn /ID# 230177

    Paderborn, Germanyno site contact published

    Recruiting

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 248748

    Berlin, Germanyno site contact published

    Recruiting

  • Dana-Farber Cancer Institute /ID# 230061

    Boston, Massachusettsno site contact published

    Recruiting

  • Fundeni Clinical Institute /ID# 241614

    Bucharest, Bucharest, Romaniano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Eligibility criteria

Inclusion

Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.
Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission.
More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment.

What this trial measures

  • Overall response (OR) in Cohort 1 after end of combination treatment9 months

    OR is defined as the percentage of participants achieving a best response of partial remission (PR), nodular partial remission (nPR), complete remission with incomplete marrow recovery (CRi), or complete remission (CR). Disease assessments will be based on the 2018 International Workshop for Chronic Lymphocytic Leukemia (iwCLL) criteria for tumor response.