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BTK Inhibitor

Venetoclax + Obinutuzumab/Acalabrutinib for Chronic Lymphocytic Leukemia

Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of > 6 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is looking at using a drug called venetoclax in combination with either obinutuzumab or acalabrutinib to treat chronic lymphocytic leukemia (CLL

Who is the study for?
Adults with previously untreated chronic lymphocytic leukemia (CLL) who need treatment and have a life expectancy over 6 months. They should be able to perform daily activities with ease or some difficulty (ECOG <=2), have good marrow function, and adequate kidney function (CrCl >=30 mL/min). Those with very large lymph nodes (>5 cm) and lower kidney function (CrCl <80 mL/min) can't join.
What is being tested?
The trial is testing the safety of venetoclax combined with obinutuzumab or acalabrutinib in treating CLL. Participants are divided into four groups receiving different combinations and dosing schedules of these drugs orally or through IV infusion. The study will last about 28 months across roughly 80 global sites.
What are the potential side effects?
Potential side effects include tumor lysis syndrome, where cancer cells break down rapidly causing complications; reactions related to IV infusions; digestive issues; fatigue; blood cell count changes; and possible infections due to weakened immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I have untreated CLL and am expected to live more than 6 months.
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My kidney function is good enough for the trial, and I don't have large lymph nodes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Percentage of Participants with Hyperkalemia-Venetoclax
Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax
Secondary study objectives
Part 1: Percentage of Participants with Adverse Events (AE) of TLS
Part 1: Percentage of Participants with Hyperkalemia
Part 1: Percentage of Participants with Reduction of Tumor Burden from Baseline
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm D: Venetoclax + AcalabrutinibExperimental Treatment2 Interventions
Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B.
Group II: Arm C: Venetoclax + AcalabrutinibExperimental Treatment2 Interventions
Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A.
Group III: Arm B: Venetoclax + AcalabrutinibExperimental Treatment2 Interventions
Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up.
Group IV: Arm A: Venetoclax + ObinutuzumabExperimental Treatment2 Interventions
Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2200
Acalabrutinib
2020
Completed Phase 2
~2080
Obinutuzumab
2014
Completed Phase 3
~3470

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,022 Previous Clinical Trials
520,059 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
443 Previous Clinical Trials
160,545 Total Patients Enrolled
~80 spots leftby Oct 2026
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