Acute Myeloid Leukemia
Conditions
Keywords
PD-1 inhibitor, Azacitidine, low-dose DLI
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
Interventions
DRUGAzacitidine
Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.
BIOLOGICALDonor 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.
DRUGCamrelizumab
Camrelizumab 200mg Q2W for sib-matched donor HSCT patients, 100mg Q2W for haploidentical or unrelated donor HSCT patients.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | ORR assessment is at day 39 (±2). | The overall response (completed remission, completed remission with incomplete blood count recovery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Progression-Free Survival (PFS) | 2 years | PFS is measured from the time of enrollment to this study to progression or death. |
| Adverse events | 1 month | It is evaluated and graded according to CTCAE 5.0. |
Countries
China
Contacts
Primary ContactSheng-Li Xue, M.D.
Outcome results
None listed