A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia

Part of paid clinical trials in Weston, Florida.

Sponsor
BeOne Medicines
Study ID
NCT06637501
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Sonrotoclax — DRUG
    Administered orally
  • Zanubrutinib — DRUG
    Administered orally

Study Details

The purpose of this study is to support the registration plan of sonrotoclax plus zanubrutinib treatment in participants with previously untreated chronic lymphocytic leukemia (CLL). This study is designed to assess the contribution of sonrotoclax to the efficacy outcome of the combination of zanubrutinib and sonrotoclax.

Key Dates

Start date
Nov 14, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Sep 30, 2029

Study Design

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

Arms

  • Experimental: Arm A: Combination Therapy: Sonrotoclax + Zanubrutinib
    Participants will receive sonrotoclax in combination with zanubrutinib daily for a fixed duration of 15 cycles.
  • Active Comparator: Arm B: Monotherapy: Zanubrutinib
    Participants will receive zanubrutinib monotherapy daily until disease progression or unacceptable toxicity, whichever occurs first.

Primary Outcome Measure

Complete Response (CR)/ Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate [ Time Frame: Month 16 ]

Locations (11)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FloridaWestonFlorida33331-3609-
Northwest Georgia Oncology Centers MariettaMariettaGeorgia30060-1152-
Illinois Cancer Specialists (Niles) UsorNilesIllinois60714-5905-
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-1544-
Nebraska Cancer SpecialistsOmahaNebraska68130-2042-
Nebraska Cancer Specialists (Satellite Site)OmahaNebraska68130-2042-
University of Nebraska Medical CenterOmahaNebraska68198-
Oncology Associates of Oregon Willamette Valley Cancer CenterEugeneOregon97401-
Texas Oncology DfwDallasTexas75231-7001-
Texas Oncology TylerTylerTexas75702-7522-
Utah Cancer Specialists Cancer CenterSalt Lake CityUtah84107-

Find similar trials in Weston, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Cleveland Clinic Florida· Weston, FLNorthwest Georgia Oncology Centers Marietta· Marietta, GAIllinois Cancer Specialists (Niles) Usor· Niles, ILUniversity of Maryland Greenebaum Comprehensive Cancer Center· Baltimore, MDNebraska Cancer Specialists· Omaha, NENebraska Cancer Specialists (Satellite Site)· Omaha, NE

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