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

NCT05772273 | Recruiting

• 1 other identifier: MA-AML-Ⅱ-002
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myeloid Leukemia

Keywords

PD-1 inhibitor; Azacitidine; low-dose DLI

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  The overall response (completed remission, completed remission with incomplete blood count recovery)

  ORR assessment is at day 39 (±2).

Secondary Outcomes (3)

• Overall Survival (OS)

  2 years

• Progression-Free Survival (PFS)

  2 years

• Adverse events

  1 month

Study Arms (1)

Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion

EXPERIMENTAL

Patients are given azacytidine for 7 days, followed by 4 DLI treatments on Days 10, 17, 24 and 31, with the dose of DLI and Camrelizumab adjusted according to the donor source. Camrelizumab infusions were given 3 hours after completion of the 1st and 3rd DLIs, respectively.

Drug: Azacitidine; Biological: Donor lymphocyte infusion; Drug: Camrelizumab

Interventions

Azacitidine DRUG

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

Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion

Donor lymphocyte infusion BIOLOGICAL

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.

Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion

Camrelizumab DRUG

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

Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of anther malignant disease.
• Suspected or proven acute or chronic GVHD.
• Proven central nervous system leukemia.
• Prior treatment with anti-PD-1, anti-PD-L1, or DLI.
• HLA loss positive.
• 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.
• Participation in another clinical study within 3 months.
• Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; camrelizumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Sheng-Li Xue, M.D.

CONTACT

+86 512 6778 1139; slxue@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 16, 2023
• Study Start: March 15, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CN (1)