Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Zulfa Omer
Study ID
NCT07014917
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    intermittent venetoclax (7days administration per cycle) + acalabrutinib
  • Acalabrutinib — DRUG
    intermittent venetoclax (7days administration per cycle) + acalabrutinib
  • Venetoclax — DRUG
    continuous venetoclax (28 days administrations per cycle) + acalabrutinib
  • Acalabrutinib — DRUG
    continuous venetoclax (28 days administrations per cycle) + acalabrutinib

Study Details

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)

Key Dates

Start date
Dec 5, 2025
Status verified
Jan 2026
Primary completion
Jun 5, 2028
Completion
Jun 5, 2032

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: intermittent venetoclax
    intermittent venetoclax (7days administration per cycle) + acalabrutinib
  • Experimental: Arm B: continuous venetoclax
    continuous venetoclax (28 days administrations per cycle) + acalabrutinib

Primary Outcome Measure

Complete Remission defined by the IWCLL 2018 criteria [ Time Frame: Post 12 cycles of treatment (each cycle is 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45219
Christine Vollmer
[email protected]
5132133203
Zulfa Omer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cincinnati, OH

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Cincinnati· Cincinnati, OH

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