Tests a PD-1 inhibitor with venetoclax and azacitidine in leukemia
Tests a PD-1 inhibitor plus two drugs in relapsed or hard-to-treat leukemia.
Plain-language title generated from the registry record
Registry title: VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 with relapsed or refractory acute myeloid leukemia, or myelodysplastic syndrome that needs chemotherapy.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Relapsed or refractory acute myeloid leukemia (AML), or myelodysplastic syndrome (MDS) that needs chemotherapy. The leukemia did not respond, came back after 1 course of induction chemotherapy, or left positive residual disease after it.
- Earlier treatment
- 1 course of induction chemotherapy with no response, relapse, or positive residual disease afterwards. Side effects of the last treatment must have recovered. No major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy or experimental therapy within 2 weeks of the first medication.
- Biomarker or test result
- Positive immune residue or positive molecular residue (if any) after induction chemotherapy.
Main reasons for not taking part
- Another malignant tumor within 2 years that is untreated or not in remission
- Other serious or uncontrolled disease, such as uncontrolled diabetes, heart failure NYHA Class III or IV, chronic renal failure or active infection
- Currently on other systemic anti-tumor or experimental anti-tumor drugs
- Pregnant or breastfeeding women
- Unwilling or unable to follow the study plan
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06536959, who can take part
Where in China
- Xiao-ning GaoBeijing, ChinaContact: Xiao-ning GaoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing 302 Hospital
- Trial code
- NCT06536959
- Record updated
- 5 August 2024
- Original description
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.Read full original descriptionShow less
A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS
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.
Inclusion: 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: Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication; Currently being treated with other systemic anti-tumor or anti-tumor research drugs; Suffering from other untreated or unrelieved malignant tumors within 2 years; 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; Women who are pregnant or breastfeeding.