A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.

Part of paid clinical trials in Tampa, Florida.

Sponsor
BeOne Medicines
Study ID
NCT06697184
Phase
PHASE1/PHASE2
Status
Recruiting
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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 establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.

Key Dates

Start date
Jan 23, 2025
Status verified
Jun 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2032

Study Design

Enrollment
258 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arms: 1A,1B and 2A: Zanubrutinib + Sonrotoclax for TN CLL
    Participants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol. The total treatment duration is of 15 cycles of 28 days (including the phase of sonrotoclax dose ramp-up)
  • Experimental: Arms: 1C and 2B: Zanubrutinib + Sonrotoclax for R/R MCL
    Participants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol, for a total of 27 cycles of 28 days (including the phase of sonrotoclax ramp-up), then will continue on zanubrutinib alone until progression of their disease or other treatment discontinuation criteria.

Primary Outcome Measure

Number of Participants who Experience Tumor Lysis Syndrome (TLS) [ Time Frame: Up to approximately 4 months ]

Central Contacts

Locations (6)

FacilityCityStateZIP
Moffitt Cancer CenterTampaFlorida33612-9496
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46804
The University of Kansas Cancer CenterWestwoodKansas66205-2003
Dana Farber Cancer InstituteBostonMassachusetts02215-5418
Washington University School of MedicineSt LouisMissouri63110-1010
Fred Hutchinson Cancer Research CenterSeattleWashington98109-4433

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