NCT07014917

Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL

Randomized Phase II Study of Intermittent Versus Continuous Venetoclax Therapy With Acalabrutinib in Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Zulfa Omer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Detailed description

This study is a two-arm, open label, Phase II multicenter clinical trial designed to evaluate the intermittent and continuous venetoclax + acalabrutinib in 2 arms in previously untreated CLL/SLL. Phase II trial will be in two separate arms using Simon's 2-stage design for each. Subjects will be randomized with 2:1 ratio into Arm A which will receive intermittent venetoclax (7days administration per cycle) + acalabrutinib and Arm B which will receive continuous venetoclax (28 days administrations per cycle) + acalabrutinib. With this trial we are seeking to establish efficacy of the combination therapy in both treatment models (intermittent and continuous venetoclax) and to acquire pilot data characterizing the effectiveness of the combination in increasing the depth of response as reflected in the rate of uMRD CR. We will reject the null hypothesis for each arm separately if CR at Cycle 12 obtained in 8 patients in Arm A and 5 patients in Arm B and move forward for a larger phase 3 study. A continuous toxicity monitoring model to monitor adverse events will be used. This model has been used successfully with phase II trials designed with the Simon 2-Stage. This methodology will allow us to monitor the cumulative number of toxic events after each patient is treated and hence to stop the study if the drug toxicities exceeded the prespecified toxicity boundary.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• CLL Variant

Interventions

Type	Name	Description
DRUG	Venetoclax	intermittent venetoclax (7days administration per cycle) + acalabrutinib
DRUG	Acalabrutinib	intermittent venetoclax (7days administration per cycle) + acalabrutinib
DRUG	Venetoclax	continuous venetoclax (28 days administrations per cycle) + acalabrutinib
DRUG	Acalabrutinib	continuous venetoclax (28 days administrations per cycle) + acalabrutinib

Timeline

• Start date: 2025-12-05
• Primary completion: 2028-06-05
• Completion: 2032-06-05
• First posted: 2025-06-11
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study