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Trial Title:
VA as Maintenance Therapy Post Allo-HSCT in MDS and AML
NCT ID:
NCT06598384
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax combined with Azacytidine
Description:
Patients were treated by venetoclax and azacytidine:
Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-7; Azacytidine 75 mg/m2
subcutaneous injection qd d1-5.
Arm group label:
Venetoclax combined with Azacytidine
Other name:
VA
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 Syndromes and Acute Myeloid Leukemia.
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 acute myeloid leukemia. overall survival (OS), cumulative
1-year relapse- and progression-free survival (RPFS), time to relapse, relapse rate,
incidence of acute and chronic GVHD, time to treatment discontinuation will be counted.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2024
Completion date:
September 2030
Lead sponsor:
Agency:
Navy General Hospital, Beijing
Agency class:
Other
Source:
Navy General Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06598384
