RecruitingPhase 2NCT07101497

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

Phase 2 Trial of Menin Inhibitor BN104 as Post Hematopoietic Stem Cell Transplantation Maintenance in Patients With Acute Leukemia

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

60 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a maintenance drug called BN104 in patients with acute leukemia who have already had a stem cell transplant from a donor, to see if it can help prevent the cancer from coming back. **You may be eligible if...** - You are 12 years or older and weigh at least 35 kg - You have been diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, or a related type - Your leukemia has certain genetic features (such as NPM1 mutation or KMT2A rearrangement) - You received a donor stem cell transplant 30 to 180 days ago and have recovered well - Your leukemia is currently in remission **You may NOT be eligible if...** - Your cancer is not in remission - You have severe organ problems (heart, liver, or kidney) - You have active graft-versus-host disease (a complication from the transplant) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBN104 monotherapy

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%.