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

Sponsor
Ruijin Hospital
Study ID
NCT06972641
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Decitabine — DRUG
    Decitabine 3.5 mg/m2 1-5d for 28 days for 6 cycles of dosing
  • Sorafenib (BAY-43-9006)，giritinib — DRUG
    Sorafenib 0.2g 2/day or giritinib 40mg 2/day orally for 2 years
  • Avastinib — DRUG
    100 mg 1/day
  • Venetoclax;Selenisol — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 10, 2025
Status verified
Apr 2025
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
126 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARM3: KIT mutation
    Initial bone marrow gene II sequencing showed KIT mutations (loci: D816, N822, exon 8, VAF ≥2%, excluding germline mutations); no TP53 mutations, AML/MR, FLT3-ITD;
  • Experimental: ARM2: FLT3-ITD mutation
    Initial bone marrow gene II sequencing showed FLT3-ITD mutation with or without NPM1 mutation, no TP53 mutation, and no AML/MR.
  • Experimental: ARM1 TP53 mutation and/or AML-MR
    TP53 mutation (VAF ≥ 2%, excluding germline mutations), and/or AML-MR (SRSF2, SF3B1, U2AF1, ZRSR2, ASXL1, EZH2, BCOR, STAG2) by second-generation sequencing of the initial bone marrow gene.
  • Experimental: ARM4: Other mutations/fusions
    MDS in the intermediate/high/very high risk group as assessed by IPSS-M or AML in the intermediate/high risk group as assessed by ELN2022 without ARM1, 2, or 3 related mutations/fusions;

Primary Outcome Measure

EFS [ Time Frame: 2 years after transplantation ]

Central Contacts

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