Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML

Sponsor
guomei
Study ID
NCT05262465
Status
Unknown

Conditions

  • Adult Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • microtransplantation, HLA-mismatched donor peripheral stem cell infusion — BIOLOGICAL
    HLA-mismatched donor peripheral stem cell infusion
  • Azacitidine — DRUG
    azacytidine 50-75mg/m2
  • Venetoclax — DRUG
    Venetoclax 100-300mg/d ×3d，400mg 4-28d

Study Details

Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.

Key Dates

Start date
Jul 1, 2020
Status verified
Feb 2022
Primary completion
Jul 1, 2023
Completion
Jul 1, 2025

Study Design

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

Arms

  • Experimental: MST for unfit
    Induction chemotherapy can use azacytidine combined with low-dose cytarabine, or azacytidine combined with BCL / 2 inhibitor, and infuse modified peripheral blood hematopoietic stem cells after chemotherapy. Consolidation chemotherapy used azacytidine combined with low-dose cytarabine. After chemotherapy, modified peripheral blood hematopoietic stem cells were infused and repeated for 3 courses.

Primary Outcome Measure

the remission rate [ Time Frame: 2month ]

Central Contacts

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