Zanubrutinib and Venetoclax in CLL (ZANU-VEN)

Part of paid clinical trials in Scarborough, Maine.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT05168930
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    C4-15
  • Zanubrutinib — DRUG
    C1-15

Study Details

This study is being done to test the effectiveness of zanubrutinib in combination with venetoclax in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Key Dates

Start date
Feb 18, 2022
Status verified
Dec 2025
Primary completion
Oct 28, 2026
Completion
Oct 28, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: BTKi and BCL2i naive
    Participants who have never received a BTK inhibitor or a BCL-2 inhibitor
  • Experimental: Cohort B: BTKi or BCL2i exposed without disease progression
    Participants who have received prior treatment with a BTK or BCL-2 inhibitor and discontinued treatment for any reason other than disease progression
  • Experimental: Cohort C: BTKi exposed and with disease progression
    Participants who experienced disease progression on a prior BTK inhibitor. Participants with BTK C481X mutation at enrollment will be excluded.

Primary Outcome Measure

Rate of undetectable minimal residual disease (uMRD) [ Time Frame: At the end of cycle 15 (each cycle is 28 days) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
New England Cancer SpecialistsScarboroughMaine04074
Patricia Collins
[email protected]
207-303-3429
John P Winters, III, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jon Arnason, MD
Jon Arnason, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Inhye E Ahn, MD
Inhye E Ahn, MD (PRINCIPAL_INVESTIGATOR)
South Shore HospitalSouth WeymouthMassachusetts02190
Nicole Hixon, RN
[email protected]
Nancy Kaddis, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scarborough, ME

By research site
New England Cancer Specialists· Scarborough, MEBeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MASouth Shore Hospital· South Weymouth, MA

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