Status:
NOT_YET_RECRUITING
VA as Maintenance Therapy Post Allo-HSCT in MDS and AML
Lead Sponsor:
Navy General Hospital, Beijing
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
The goal of this phase 2 trial is to test the safety and efficacy of Venetoclax combined with Azacytidine as Maintenance Therapy post Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndrom...
Detailed Description
The investigators will evaluate the efficacy and safety of venetoclax combined with azacytidine as maintenance therapy post hematopoietic stem cell transplantation in myelodysplastic syndromes and acu...
Eligibility Criteria
Inclusion
- The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
- The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
- Patients aged ≥18 years with a diagnosis of MDS or AML according to World Health Organization criteria (WHO) who had undergone alloSCT with myeloablative or reduced-intensity conditioning regimens were eligible. Related and unrelated donors were permitted.
- Patients should be in morphologic complete remission (CR; ie, ≤5% bone marrow blasts) with absolute neutrophil counts ≥1.0×10\^9 /L and platelets ≥ 75×10\^ 9 /L before treatment.
Exclusion
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
- Pregnant or lactating women.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06598384
Start Date
September 1 2024
End Date
September 1 2030
Last Update
October 1 2024
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