NCT05772273 PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allo-HSCT
| NCT ID | NCT05772273 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 43 participants in total. It began in 2023-03-15 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05772273 clinical trial?
This trial is open to participants of all sexes, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05772273 currently recruiting?
Yes, NCT05772273 is actively recruiting participants. Contact the research team at slxue@suda.edu.cn for enrollment information.
Where is the NCT05772273 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT05772273 clinical trial?
NCT05772273 is sponsored by The First Affiliated Hospital of Soochow University. The trial plans to enroll 43 participants.
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