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

Launched by BEIJING 302 HOSPITAL · Jul 31, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). The researchers are looking at a combination of three drugs: a PD-1 inhibitor, venetoclax, and a hypomethylation agent. The goal is to see how safe this combination is and how well it works for patients who haven’t responded to previous treatments or whose cancer has returned.

To join the study, patients need to have been diagnosed with relapsed AML or high-risk MDS and must require chemotherapy. They should have experienced a lack of response or recurrence after at least one round of initial chemotherapy. Participants will need to be physically able to handle the treatment and must have recovered from any side effects of prior therapies. The trial is currently recruiting participants aged between 65 and 75, and both men and women can apply. Those who join can expect to undergo various tests to monitor their health and response to the treatment throughout the study.

Gender

ALL

Eligibility criteria

• 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.