Combining PD-1 inhibitor with Azacitidine and low-dose DLI for AML relapse after stem cell transplant

Efficacy and Safety of PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

This study is testing a new treatment combining a PD-1 inhibitor, Azacitidine, and low-dose donor lymphocyte infusion to see if it can help people with acute myeloid leukemia who have relapsed after a stem cell transplant.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05772273 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a combination treatment involving a PD-1 inhibitor, Azacitidine, and low-dose donor lymphocyte infusion (DLI) for patients experiencing relapse of acute myeloid leukemia (AML) after undergoing allogeneic hematopoietic stem cell transplantation. The approach aims to enhance the immune response against leukemia cells while minimizing potential side effects. Eligible participants will be closely monitored for treatment outcomes and any adverse effects throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with a diagnosis of AML relapse following allogeneic hematopoietic stem cell transplantation and adequate organ function.

Not a fit: Patients with other malignancies, active graft-versus-host disease, or prior treatment with similar therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with AML relapse after stem cell transplantation.

How similar studies have performed: While the combination of these treatments is innovative, similar approaches have shown promise in other studies, indicating potential for success.

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.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Sheng-Li Xue, M.D.

Conditions Acute Myeloid Leukemia; PD-1 inhibitor; Azacitidine; low-dose DLI