Phase 2 Trial of BN104 as Post-HSCT Maintenance in Acute Leukemia

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT07101497
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Leukemia
  • KMT2A Rearrangement
  • Maintenance Therapy
  • Menin Inhibitors
  • NPM1 Mutation
  • NUP98 Gene Rearrangement
  • Post Hematopoietic Stem Cell Transplantation

Eligibility Criteria

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

Interventions

  • BN104 monotherapy — DRUG
    BN104 will be started at 200 mg or 300mg, to a target dose of 400mg, twice daily, orally, 28 days a cycle, for a total of 24 to 36 cycles . When used in combination with posaconazoles and voriconazole, the dose of BN104 should be reduced by 50%.

Study Details

This is a phase 2, open label, single arm trial. This study aims to assess the efficacy and safety of menin inhibitor BN104 as maintenance therapy in patients with acute leukemia harboring specific genetic alterations who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). Eligible patients will be screened at 30-180 days post allo-HSCT. Participants will take BN104 100-200mg orally, twice a day, 28 days a cycle for 24-36 cycles. The primary endpoint is 2-year relapse-free survival rate since enrollment. The secondary endpoints included overall survival, event-free survival, cumulative incidence of relapse, non relpase related mortality and safety.

Key Dates

First listed
Aug 3, 2025
Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2027
Completion
Dec 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BN104 maitenenace
    Eligible patients will take BN104 start from 200 or 300mg, to a targent dose of 400mg, twice daily orally, 28 days for a cycle. When used in combination with posaconazoles and voriconazole, the dose of BN104 should be reduced by 50%. A total of 24 to 36 cycles of BN104 was planned.

Primary Outcome Measure

2-year rate of RFS [ Time Frame: 2 years ]

Central Contacts

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