PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allo-HSCT
Not Applicable
Recruiting
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Registration Number
- NCT05772273
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion 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. Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion Camrelizumab 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. Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion Azacitidine 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.
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) ORR assessment is at day 39 (±2). The overall response (completed remission, completed remission with incomplete blood count recovery)
- Secondary Outcome Measures
Name Time Method Adverse events 1 month It is evaluated and graded according to CTCAE 5.0.
Progression-Free Survival (PFS) 2 years PFS is measured from the time of enrollment to this study to progression or death.
Overall Survival (OS) 2 years 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.
Trial Locations
- Locations (1)
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China