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Clinical Trials in China / NCT05772273
Recruiting Not applicable

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

NCT05772273 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Soochow University
Phase
Not applicable
Started
2023-03-15
Last updated
2026-09-02

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

Azacitidine →Donor lymphocyte infusionCamrelizumab →

Azacitidine: Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.

Donor lymphocyte infusion: The 4 DLI doses (dose range: ±10%) of sib-matched donor HSCT patients were 1×10\^6/kg, 5×10\^6/kg, 1×10\^7/kg, 5×10\^7/kg; The 4 DLI doses (dose range: ±10%) of haploidentical or unrelated donor HSCT patients were 1×10\^5/kg, 5×10\^5/kg, 1×10\^6/kg, 5×10\^6/kg.

Camrelizumab: Camrelizumab 200mg Q2W for sib-matched donor HSCT patients, 100mg Q2W for haploidentical or unrelated donor HSCT patients.

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting

More The First Affiliated Hospital of Soochow University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05772273 on ClinicalTrials.gov ↗ ← All trials in China