RecruitingNot ApplicableNCT05772273

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

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

43 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three treatments — a PD-1 immune checkpoint inhibitor, azacitidine (a chemotherapy drug), and low-dose donor lymphocyte infusion (DLI, which involves giving immune cells from the original stem cell donor) — for people whose acute myeloid leukemia (AML) has come back after a stem cell transplant. **You may be eligible if...** - You have been diagnosed with AML that has relapsed after an allogeneic (donor) stem cell transplant - You are between 18 and 60 years old - Your organs are functioning adequately - You are willing to use contraception during the study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have severe organ failure - You are unable to provide informed consent - You have active uncontrolled infections or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine

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

BIOLOGICALDonor 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.

DRUGCamrelizumab

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

Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT05772273

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