Actively Recruiting

Phase Not Applicable
All Genders
NCT05772273

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

Led by The First Affiliated Hospital of Soochow University · Updated on 2025-11-21

43

Participants Needed

1

Research Sites

198 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital of Soochow University

Lead Sponsor

J

Jiangsu HengRui Medicine Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of AML relapse after allogeneic hematopoietic stem cell transplantation
  • Adequate organ function
  • Able to understand and sign informed consent
  • Age 18 to 60 years old
  • Negative pregnancy test for females of childbearing potential within one week prior to treatment
  • Use of highly effective contraception during the study and for at least 90 days after last treatment dose for females of childbearing potential and sexually active males
  • ECOG performance status 0 or 1
  • Known HLA-matched donor without contraindications to donate
  • Life expectancy greater than 3 months
Not Eligible

You will not qualify if you...

  • Diagnosis of another malignant disease
  • Suspected or proven acute or chronic graft-versus-host disease (GVHD)
  • Proven central nervous system leukemia
  • Prior treatment with anti-PD-1, anti-PD-L1, or donor lymphocyte infusion
  • HLA loss positive
  • Known active viral infections including HIV, hepatitis B or C, or COVID-19
  • Uncontrolled systemic fungal, bacterial, or viral infection
  • Known or suspected hypersensitivity to PD-1 inhibitors or azacitidine
  • Participation in another clinical study within the last 3 months
  • Any serious medical or psychiatric illness that may interfere with study completion based on investigator's opinion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

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Research Team

S

Sheng-Li Xue, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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