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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772273
• Other study ID #: MA-AML-?-002
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: The First Affiliated Hospital of Soochow University
• Contact: Sheng-Li Xue, M.D.
• Phone: +86 512 6778 1139
• Email: slxue[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia

Intervention

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

Biological:
• Donor lymphocyte infusion
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.

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	The overall response (completed remission, completed remission with incomplete blood count recovery)	ORR assessment is at day 39 (±2).
Secondary	Overall Survival (OS)	OS is measured from the time of enrollment to this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.	2 years
Secondary	Progression-Free Survival (PFS)	PFS is measured from the time of enrollment to this study to progression or death.	2 years
Secondary	Adverse events	It is evaluated and graded according to CTCAE 5.0.	1 month