Combining PD-1 inhibitor with venetoclax for treating tough cases of leukemia and myelodysplastic syndromes
A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS
This study is testing a new treatment that combines three drugs to see if it can help people with tough cases of leukemia and myelodysplastic syndromes who haven't responded to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06536959 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of a new treatment regimen that combines a PD-1 inhibitor with venetoclax and a hypomethylation agent for patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). The study aims to determine how well this triple-drug combination works in patients who have not responded to previous treatments or have minimal residual disease. Participants will undergo a series of assessments to monitor their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with relapsed or refractory AML or high-risk MDS who require chemotherapy and have not responded to prior treatments.
Not a fit: Patients who are not diagnosed with relapsed or refractory AML or high-risk MDS, or those who are currently pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat forms of leukemia and myelodysplastic syndromes.
How similar studies have performed: While the combination of PD-1 inhibitors with other treatments is being explored, this specific approach in relapsed/refractory AML and high-risk MDS is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Xiao-ning Gao — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.