Combining PD-1 inhibitor with Azacitidine and low-dose DLI for AML relapse after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of a combination treatment involving a PD-1 inhibitor, Azacitidine, and low-dose donor lymphocyte infusion (DLI) for patients experiencing relapse of acute myeloid leukemia (AML) after undergoing allogeneic hematopoietic stem cell transplantation. The approach aims to enhance the immune response against leukemia cells while minimizing potential side effects. Eligible participants will be closely monitored for treatment outcomes and any adverse effects throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with a diagnosis of AML relapse after allogeneic hematopoietic stem cell transplantation.
2. Adequate organ function.
3. Be able to understand and sign informed consent.
4. Age 18 to 60 years old.
5. Serum pregnancy test for females of childbearing potential that is negative within one week prior to initiation of first dose of treatment. Female patients of childbearing potential and sexually active males must agree to use a highly effective method of contraception throughout the study and for at least 90 days after the last dose of assigned treatment.
6. ECOG performance status ≤ 1.
7. Known HLA-matched donor without contraindications to donate.
8. Life expectancy \> 3 months.

Exclusion Criteria:

1. Diagnosis of anther malignant disease.
2. Suspected or proven acute or chronic GVHD.
3. Proven central nervous system leukemia.
4. Prior treatment with anti-PD-1, anti-PD-L1, or DLI.
5. HLA loss positive.
6. Known active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B (HBV) or C (HCV) or Corona Virus Disease 2019(COVID-19);
7. Uncontrolled systemic fungal, bacterial, or viral infection.
8. Known or suspected hypersensitivity to PD-1 inhibitor or azacytidine.
9. Participation in another clinical study within 3 months.
10. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Sheng-Li Xue, M.D.
• Email: slxue@suda.edu.cn
• Phone: +86 512 6778 1139

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.