Clinical trial · Interventional
Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.
A Single Arm, Phase 2 Study Evaluating Safety and Efficacy of Maintenance Therapy With Hypomethylating Agent and Venetoclax After Allogeneic Stem Cell Transplantation in Patients With f High-risk Myeloid Malignancies.
NCT05841771CI-TRIAL-00079670unknownPhase 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 main objective of the study is to evaluate the efficacy and safety of maintenance therapy with hypomethylating agent and Venetoclax to improve leukemia free survival for high-risk myeloid malignancies after allogeneic hematopoietic stem cell transplantation .
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypomethylating Agent | — | UNRESOLVED | — |
| Myeloid Malignancy | — | UNRESOLVED | — |
| Venetoclax | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine or decitabine | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZA-VEN maintenance
- description
- hypomethylating agents (azacytidine 32mg/m2 or decitabine 5mg/m2) for 5 days and venetoclax 400mg/d for 7 days, repeated every 28 days until up to 1-year posttransplant.
- interventionNames
- Drug: Venetoclax
- Drug: Azacitidine or decitabine
Primary outcomes (1)
- measure
- Leukemia-free survival (LFS) time
- timeFrame
- From the date of transplantation, assessed up to 1 year after transplantation.
- description
- Summary statistics for LFS time will be computed for all patients.
Secondary outcomes (3)
- measure
- Cumulative incidence of relapse
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with AML or MDS and have received allogeneic hematopoietic cell transplantation; * Patients with AML must have one of the following high-risk factors: Cytogenetics and molecular features consistent with adverse risk group by European LeukemiaNet classification for AML; require more than 2 courses of induction chemotherapy to reach complete remission; Extramedullary myeloid malignancy;≥CR2; Presence of measurable residual disease at the time of HSCT. \* * Patients with MDS must have one of the following high-risk factors: IPSS-R scores are high-risk or very high-risk; Presence of TP53 mutation; Presence of measurable residual disease at the time of HSCT. \* * CBC: ANC ≥ 1.0 × 10e9/L, Hb ≥ 80g/L, and PLT ≥ 50 × 10e9/L; * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Presence of measurable residual disease at the time of HSCT is defined as the following: Blast percentage in bone marrow detected by flow cytometry ≥0.01%; Presence of fusion gene or mutated gene by qPCR. Exclusion Criteria: * Concurrent use of targeted drugs ; * Resistant to Venetoclax before transplantation; * Allergic to decitabine , Azacitidine or venetoclax; * Active grade II or higher acute GVHD ; * Active moderate or severe chronic GVHD ; * Diseases recurrence (abnormal myeloid cells detected by flow cytometry \>0.01%, presence of WT1 or other genes, or extramedullary malignancy ), percentage of donor cells in bone marrow \<90% or graft rejection: * CBC: ANC \< 1.0 × 10e9/L, or PLT \< 50 × 10e9/L; * Severe organ dysfunction: Elevated Aspartate transaminase (AST) /alanine transaminase (ALT), or direct bilirubin \>3 times upper limit of normal; Creatinine clearance (Ccr)\<50mL/min or serum creatinine \>1.5 times upper limit of normal, whether hemodialysis treatment is performed; * Active uncontrolled systemic fungal, bacterial, or viral infection * Pregnant or lactating women; * Other severe complications and not suitable judged by researchers.
References
Publications (0)
Data not yet available
No reference posted for this study.