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Recruiting NCT06536959

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

Phase II Interventional Relapsed Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Myelodysplastic Syndromes Minimal Residual Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine.
Who it may be relevant to
Registry conditions: Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Minimal Residual Disease. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine
    For AML patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. For MDS patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 14 days per cycle. Decitabine was giv

Primary outcome measures

  • Complete remission rate [Time frame: At the end of Cycle 2 (each cycle is 28 days)]
  • Complete minimal residual disease (MRD) Response Rate [Time frame: At the end of Cycle 2 (each cycle is 28 days)]
  • MRD Response Rate [Time frame: At the end of Cycle 2 (each cycle is 28 days)]
Secondary outcome measures (4)
  • Relapse-Free Survival [Time frame: 24 months]
  • Overall Survival [Time frame: 24 months]
  • Duration of response [Time frame: 24 months]
  • Adverse events [Time frame: start of treatment to 2 weeks after end of treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Xiao-ning Gao — Beijing

Identifiers

NCT: NCT06536959 · VA-PD1-MN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗