Clinical trial NCT06536959: VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS
Official title: A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Relapsed Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Myelodysplastic Syndromes
Minimal Residual Disease
Keywords: Venetoclax
Hypomethylation agen
PD-1 inhibitor
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Complete remission rate
timeFrame: At the end of Cycle 2 (each cycle is 28 days)
measure: Complete minimal residual disease (MRD) Response Rate
timeFrame: At the end of Cycle 2 (each cycle is 28 days)
measure: MRD Response Rate
timeFrame: At the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes:
measure: Relapse-Free Survival
timeFrame: 24 months
measure: Overall Survival
timeFrame: 24 months
measure: Duration of response
timeFrame: 24 months
measure: Adverse events
timeFrame: start of treatment to 2 weeks after end of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiao-ning Gao
state: Beijing
Study officials:
References: