Actively Recruiting
Phase 2 Trial of BN104 as Post-HSCT Maintenance in Acute Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-08-03
60
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 2 Trial of BN104 as Post-HSCT Maintenance in Acute Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients.
- Age 12 years or older and weighing at least 35 kg.
- Diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, or ambiguous acute leukemia according to WHO 2022 classification.
- Classified as intermediate or high risk according to ELN risk stratification.
- Having one of the following genetic alterations: somatic NPM1 mutation without FLT3-ITD/TKD co-mutations; KMT2A rearrangement or KMT2A-PTD; NUP98 rearrangement; or other menin-KMT2A dependent genetic changes.
- Received allogeneic hematopoietic stem cell transplantation between 30 and 180 days before starting BN104 maintenance therapy.
- Achieved full donor chimerism and blood recovery with ANC ≥ 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L, no red blood cell or platelet transfusions within 7 days, and no G-CSF or GM-CSF within 72 hours.
- Achieved complete hematologic remission confirmed by bone marrow analysis within 14 days before study entry (defined as <5% marrow blasts, no peripheral blasts, platelet count > 75 x 10^9/L, WBC count > 3.5 G/L, ANC ≥ 1.0 x 10^9/L).
- No extramedullary leukemia.
- ECOG performance status score of 0 to 2.
- Adequate organ function.
- Provided informed consent (patients and guardians for ages 12-17).
- Written informed consent.
You will not qualify if you...
- Active and uncontrolled infections.
- Viral activation such as CMV viremia with DNA > 400 copies/ml, EBV viremia with DNA > 400 copies/ml, or evidence of adenovirus or human parvovirus B19 activation.
- Active hepatitis B, hepatitis C, or HIV infection.
- Cardiac conditions including inherited long QT syndrome or congestive heart failure with NYHA grade 2 or higher.
- Grade 2 or higher acute graft-versus-host disease or grade 3 or higher chronic graft-versus-host disease requiring systemic therapy.
- Prior use of other maintenance therapies like hypomethylating agents, targeted drugs (Bcl-2, FLT3, IDH1/2 inhibitors), interferon, interleukin-2, donor lymphocyte infusion, or chemotherapy.
- History of other malignancies requiring systemic treatment (except those in stable remission without maintenance therapy).
- Gastrointestinal conditions affecting oral drug intake or absorption (e.g., dysphagia, gastroparesis, uncontrolled chronic diarrhea, intestinal graft-versus-host disease).
- Pregnancy or breastfeeding.
- Hypersensitivity to BN104.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Su-ning Chen, M.D.
CONTACT
H
Hai-ping Dai, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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