Clinical trial · Interventional
VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS
A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS
- 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 efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Minimal Residual Disease | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Relapsed Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VA-PD1i
- description
- Patients are treated with PD-1 inhibitor combined with venetoclax and decitabine/azacytidine.
- interventionNames
- Drug: PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine
Primary outcomes (3)
- measure
- Complete remission rate
- timeFrame
- At the end of Cycle 2 (each cycle is 28 days)
- description
- percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
- measure
- Complete minimal residual disease (MRD) Response Rate
- timeFrame
- At the end of Cycle 2 (each cycle is 28 days)
- description
- Percentage of subjects with MRD negative or MRD \< 0.01%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment. * Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy. * Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures. * The toxic and side effects caused by the last treatment should be recovered. * Eastern Cooperative Oncology Group score of 0 to 3 points. * The organ function is intact. * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2×ULN (Upper Limit of Normal). * Creatinine≤2×ULN. * Bilirubin≤2×ULN. * Karnofsky≥70. * The expected survival period is at least 12 weeks. * Non-pregnant, non-breastfeeding women. Exclusion Criteria: * Suffering from other untreated or unrelieved malignant tumors within 2 years. * Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication. * Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association \[NYHA\] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial. * Patients who are unwilling or unable to comply with the protocol. * Currently being treated with other systemic anti-tumor or anti-tumor research drugs. * Women who are pregnant or breastfeeding.
References
Publications (0)
Data not yet available