VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS

Beijing 302 Hospital

Status and phase

Enrolling

Phase 2

Conditions

Refractory Acute Myeloid Leukemia

Myelodysplastic Syndromes

Relapsed Acute Myeloid Leukemia

Minimal Residual Disease

Treatments

Drug: PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine

Study type

Interventional

Funder types

Other

Identifiers

NCT06536959

VA-PD1-MN

Details and patient eligibility

About

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.

Enrollment

67 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.