RecruitingPhase 2Phase 3NCT06972641

Molecular Genetics Guide the Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation

A Prospective, Multicenter Umbrella Study Based on Molecular Genetics to Guide the Efficacy and Safety of Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia/Myelodysplastic Syndrome

Sponsor

Ruijin Hospital

Enrollment

126 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

AML MDS

Summary

This study is a prospective, multicenter, open-label umbrella clinical study planned to enroll 126 subjects with acute myeloid leukemia/myelodysplastic syndromes undergoing allogeneic hematopoietic stem cell transplantation. Subjects eligible for enrollment were grouped based on the results of the initial myeloid genomic second-generation sequencing, and were given different regimens of maintenance therapy, with the aim of evaluating the efficacy and safety of the maintenance regimen.

Eligibility

Min Age: 14 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether targeted maintenance therapy after a bone marrow transplant — matched to each patient's specific genetic mutations — can prevent leukemia or myelodysplastic syndrome (MDS) from coming back. **You may be eligible if...** - You are between 14 and 75 years old - You have had a stem cell (bone marrow) transplant for leukemia or MDS - Your cancer has specific genetic mutations (such as TP53, FLT3-ITD, KIT, or certain MDS-related gene changes) identified before the transplant **You may NOT be eligible if...** - Your cancer does not fit one of the specific genetic profiles being studied - You are under 14 or over 75 years old 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

DRUGDecitabine

Decitabine 3.5 mg/m2 1-5d for 28 days for 6 cycles of dosing

DRUGSorafenib (BAY-43-9006)，giritinib

Sorafenib 0.2g 2/day or giritinib 40mg 2/day orally for 2 years

DRUGAvastinib

100 mg 1/day

DRUGVenetoclax;Selenisol

Vinaclat: 50-100mg 1/day orally, d1-14 1/day per month (adjust drug dosage based on blood levels), 28-day cycle; Selenisol: 20mg qw orally (weeks 1 and 2), 28-day cycle If the above treatment is not tolerated, adjust the regimen to decitabine 3.5 mg/m2 1-5 d; 28 days as a cycle of 6 cycles of medication; Vinaclat: 50-100 mg 1/day orally, d1-14 1/day per month orally (adjust the dose of the drug according to the blood concentration), 28 days as a cycle of medication