NCT05772273Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 27 Feb 2023
- Start date
- 15 Mar 2023
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT05772273
What you commit to
- Study type: Interventional
- Planned participants: 43
- From 15 Mar 2023 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with anti-PD-1, anti-PD-L1, or DLI.
Other illness
- Diagnosis of anther malignant disease.
- 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);
- Uncontrolled systemic fungal, bacterial, or viral infection.
- Known or suspected hypersensitivity to PD-1 inhibitor or azacytidine.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures.
Other
- Suspected or proven acute or chronic GVHD.
- Proven central nervous system leukemia.
- HLA loss positive.
- Participation in another clinical study within 3 months.
Who the study is looking for
- Patients with a diagnosis of AML relapse after allogeneic hematopoietic stem cell transplantation.
- Adequate organ function.
- Be able to understand and sign informed consent.
- Age 18 to 60 years old.
- 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.
- ECOG performance status ≤ 1.
- Known HLA-matched donor without contraindications to donate.
- Life expectancy \> 3 months.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.