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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Sheng-Li Xue, M.D.
slxue@suda.edu.cn
+86 512 6778 1139
Time Frame
Start Date: 2023-03-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 43
Treatments
Experimental: Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion
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.
Sponsors
Leads: The First Affiliated Hospital of Soochow University
Collaborators: Jiangsu HengRui Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov

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