Status:
RECRUITING
VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS
Lead Sponsor:
Beijing 302 Hospital
Conditions:
Relapsed Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 uncertai...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT06536959
Start Date
July 18 2024
End Date
July 31 2027
Last Update
August 5 2024
Active Locations (1)
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1
Xiao-ning Gao
Beijing, Beijing Municipality, China, 100071