Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
AstraZeneca
Study ID
NCT07024706
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Acalabrutinib is an orally available cBTKi that inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway.
  • Venetoclax — DRUG
    Venetoclax is an orally bioavailable inhibitor of the anti-apoptotic protein BCL-2

Study Details

This study will evaluate the efficacy and safety of finite-duration acalabrutinib plus venetoclax therapy in patients with relapsed CLL or SLL, and have previously responded to first line (1L) cBTKi + BCL2i therapy (± obinutuzumab) and maintained a response for at least two years post-treatment.

Key Dates

First listed
Jun 17, 2025
Start date
Jun 4, 2026
Status verified
Jun 2026
Primary completion
May 1, 2029
Completion
Mar 23, 2033

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acalabrutinib and Venetoclax
    For Cohort 1, each participant will be in the study for approximately 5 years (60 months) counting from C1D1, starting with 2 cycles of acalabrutinib lead-in treatment, followed by 12 cycles of AV combination treatment, and 4 years of follow-up. For Cohort 2, each participant will be in the study for approximately 5 years (60 months) counting from C1D1 starting with 2 cycles of acalabrutinib lead-in treatment, followed by 22 cycles of AV combination treatment, and 3 years of follow-up.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: ORR assessed at multiple timepoints during treatment period (each cycle is 28 days). Timepoint for primary analysis is at completion of cycle 14 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteBostonMassachusetts02215-
Research SiteCharlotteNorth Carolina28204-
Research SiteCharlotteNorth Carolina28204-
Research SiteDurhamNorth Carolina27705-
Research SiteWinston-SalemNorth Carolina27103-

Find similar trials in Boston, MA

By research site
Research Site· Boston, MAResearch Site· Charlotte, NCResearch Site· Durham, NCResearch Site· Winston-Salem, NC

Related Studies