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NCT03836261 · ClinicalTrials.gov registry record · Phase 3
Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
A Phase 3 study of Chronic Lymphocytic Leukemia, sponsored by Acerta Pharma.
- Active
- Registry status
- Phase 3
- Development phase
- 984
- Enrollment target
- 20
- Study locations
NCT03836261: Active Phase 3 study of Chronic Lymphocytic Leukemia, sponsored by Acerta Pharma.
NCT03836261 is a Phase 3 study of Chronic Lymphocytic Leukemia that is active but no longer recruiting, run by Acerta Pharma. The registered enrollment target is 984 participants, above the 177-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (456% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03836261, a Phase 3 study of Chronic Lymphocytic Leukemia, is active but no longer recruiting, sponsored by Acerta Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 984 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL
Primary Outcome
Progression-free survival (PFS) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the Independent Review Committee (IRC) according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG Acalabrutinib
- DRUG Chemoimmunotherapy
Study Locations (20)
Other
- Research Site - Buenos Aires
- Research Site - Buenos Aires
- Research Site - Capital Federal
- Research Site - Córdoba
California
- Research Site - Los Angeles
- Research Site - Redondo Beach
Pennsylvania
- Research Site - Pittsburgh
- Research Site - Pittsburgh
Washington
- Research Site - Spokane
- Research Site - Tacoma
Indiana
- Research Site - Fort Wayne
Kansas
- Research Site - Wichita
Kentucky
- Research Site - Louisville
Louisiana
- Research Site - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 984 participants |
| Start Date | 2019-02-25 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 3 |
What the registry record for NCT03836261 still lists
NCT03836261 is an interventional study that assigns participants to a tested intervention. The registered 984 participants enrollment target is mid-sized for trials with a published cap, above the 177-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (456% higher).
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Obinutuzumab is the first listed.
NCT03836261 names 20 study sites across 14 states, led by Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03836261 about?
NCT03836261 is a clinical study titled "Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL". The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL
What is the current status of trial NCT03836261?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 984 participants. The study started on 2019-02-25. Estimated completion is 2027-01-31.
What conditions does trial NCT03836261 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT03836261?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Acalabrutinib (DRUG), Chemoimmunotherapy (DRUG).
Who is sponsoring clinical trial NCT03836261?
This trial is sponsored by Acerta Pharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03836261 being conducted?
This trial has 20 study locations across California, Indiana, Kansas, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03836261's enrollment target sits among peer trials
984 6th of 187 higher than 182 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Long-term Extension Study of PCI-32765 (Ibrutinib)
RECRUITING · Phase 3
-
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
RECRUITING · Phase 3
-
A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
RECRUITING · Phase 3
-
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
RECRUITING · Phase 3
-
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
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-
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
RECRUITING · Phase 3
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