Clinical trial · Interventional
Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults
A Multi-center, Phase II, Single-arm Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults
NCT05282719CI-TRIAL-00057135unknownPhase 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)
To explore the efficacy of venetoclax combined with azacytidine in Myelodysplastic / myeloproliferative neoplasms（MDS/MPN）, so as to improve the overall survival and treatment status of MDS/MPN patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| venetoclax combined with azacitidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment regime
- description
- On day 1 of each cycle, decitabine 75 mg/m2 will be given subcutaneously, and will continue for 5 days. Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 14 day cycle is finished.
- interventionNames
- Drug: venetoclax combined with azacitidine
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Study start date to study end date, or death, whichever comes first, up to 4 years
- description
- ORR (equals the rates of complete remission \[CR\]+partial remission \[PR\]+complete cytogenetic remission \[CCyR\]+marrow response \[MR\[+clinical benefit \[CB\] )of venetoclax in combination with azacitidine. 1. CR and CCyR are shown in the secondary outcome measures below. 2. PR: Normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts (and blast equivalents) reduced by 50%, but remaining\>5% of cellularity except in cases of MDS/MPN with≤5% bone marrow blasts at baseline. 3. MR: Optimal marrow response: Presence of all marrow criteria necessary for CR without normalization of peripheral blood indices. Partial marrow response: Bone marrow blasts (and blast equivalents) reduced by 50%, but remaining\>5% of cellularity, or reduction in grading of reticulin fibrosis from baseline on at least 2 bone marrow evaluations spaced at least 2 months apart. 4. CB: Hematology improvement, spleen response and symptom response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, Age (years) \>= 18； 2. Patients newly diagnosed or previously treated with MDS/MPNs (CMML, MDS/MPN-U, aCML) according to 2016 WHO diagnostic criteria: Initial diagnosis: CMML: CPSS-mol intermediate risk 2 and above; aCML; MDS/MPN-U. Previous treatment: HMA treatment failed. 3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ; 4. Liver function: Total bilirubin ≤3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3 ULN; alanine aminotransferase (ALT)≤3 ULN； 5. Renal function#Ccr ≥30 ml/min; 6. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent. Exclusion Criteria: 1. Acute myeloid leukemia 2. Myelodysplastic syndrome 3. Subjects who had previously been treated with Venetoclax 4. Subjects who are known to be allergic to ingredients of the study drug or their analogues 5. HIV infection 6. HBV-DNA or HCV-RNA positive 7. Subjects with grade 2 or above cardiac failure and those considered unsuitable for inclusion by the investigator 8. Subjects who are pregnant or breastfeeding 9. Subjects reject to participate in the study
References
Publications (0)
Data not yet available
No reference posted for this study.