VA as Maintenance Therapy Post Allo-HSCT in MDS and AML
ConditionAcute Myeloid Leukemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorNavy General Hospital, Beijing
About this trial
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 Syndromes and Acute Myeloid Leukemia.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Venetoclax combined with Azacytidine
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov