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NCT05336812 · ClinicalTrials.gov registry record · Phase 2
Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia
A Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Ohio State University Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT05336812 is a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is actively recruiting participants, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 52 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05336812, a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is actively recruiting participants, sponsored by Ohio State University Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests whether acalabrutinib in combination with venetoclax or obinutuzumab works to shrink tumors in patients with treatment-naive chronic lymphocytic leukemia . Acalabrutinib is also an inhibitor that works in the body to block the activation of certain cells that lead to the growth of cancerous B cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib in combination with venetoclax or obinutuzumab may help ease symptoms, decrease the amount of cancer suggestive of improvement, prolonged disease-free remission and/or survival, and increased knowledge about cancer treatment in patients with chronic lymphocytic leukemia. Patients will be treated with acalabrutinib for 12 cycles, and then randomized to receive 6 cycles of acalabrutinib plus obinutuzumab or acalabrutinib plus venetoclax.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Acalabrutinib
- BIOLOGICAL Obinutuzumab
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05336812
The ClinicalTrials.gov registry entry for NCT05336812 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (71% lower). The listed sponsor is Ohio State University Comprehensive Cancer Center, which has 341 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT05336812 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05336812 about?
NCT05336812 is a clinical study titled "Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia". This phase II trial tests whether acalabrutinib in combination with venetoclax or obinutuzumab works to shrink tumors in patients with treatment-naive chronic lymphocytic leukemia . Acalabrutinib is also an inhibitor that works in the body to block the activation of certain cells that lead to the gr...
What is the current status of trial NCT05336812?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2022-09-13. Estimated completion is 2026-10-31.
What conditions does trial NCT05336812 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT05336812?
The interventions under investigation include: Venetoclax (DRUG), Acalabrutinib (DRUG), Obinutuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05336812?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05336812 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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