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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: Recruiting Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Ohio State University Comprehensive Cancer Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Will provide uMRD rates at the end of treatment with combination therapy for each experimental arm with 95% confidence intervals.

Conditions Studied

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Interventions

  • DRUG Venetoclax
  • DRUG Acalabrutinib
  • BIOLOGICAL Obinutuzumab

Study Locations (1)

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2022-09-13
Est. Completion 2026-10-31
Phase Phase 2
Ohio State University Comprehensive Cancer Center

341 total trials

What NCT05336812 shows while recruiting

NCT05336812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (71% lower).

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 a single indexed study location in 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.

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 NCT05336812's enrollment target sits among peer trials

52 100th of 187 higher than 88 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

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More recruiting context for NCT05336812

Source: ClinicalTrials.gov NCT05336812, the US trial registry maintained by the National Library of Medicine. NCT05336812 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.