Clinical trial · Interventional
VA as Maintenance Therapy Post Allo-HSCT in MDS and AML
Venetoclax Combined With Azacytidine as Maintenance Therapy Post Allogeneic Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndromes and Acute Myeloid Leukemia
NCT06598384CI-TRIAL-00081220not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax combined with Azacytidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Venetoclax combined with Azacytidine
- description
- Patients were treated by venetoclax and azacytidine
- interventionNames
- Drug: Venetoclax combined with Azacytidine
Primary outcomes (1)
- measure
- Relapse Rate
- timeFrame
- 1 year
- description
- Relapse following CR is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.
Secondary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- through study completion, an average of 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.