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RECRUITINGNA

PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allo-HSCT

Efficacy and Safety of PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

NCT05772273•The First Affiliated Hospital of Soochow University

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Summary

This study aims to evaluate the efficacy and safety of PD-1 inhibitor, Azacitidine, and low-dose DLI in AML relapse After allogeneic hematopoietic stem cell transplantation

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

March 15, 2023

Primary Completion Date

July 1, 2026

Completion Date

December 31, 2026

Last Updated

November 21, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia

Interventions

Azacitidine

DRUG

Donor lymphocyte infusion

BIOLOGICAL

Camrelizumab

DRUG

Contacts

Sheng-Li Xue, M.D.

CONTACT

+86 512 6778 1139 slxue@suda.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allo-HSCT

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

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