VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS
About this study
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.
- Condition
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Minimal Residual Disease
- Tested
- PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine
- Sponsor
- Beijing 302 Hospital
Who can join
- Age
- 18 to 70 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 15
- Minimum age: 18 years
- Maximum age: 70 years
- Study condition: Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Minimal Residual Disease
- 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 6
- 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.
Where
1 site, 1 recruiting
Xiao-ning Gao
Beijing, Beijing Municipality, China
Potential match only. Final eligibility is determined by the study team.