Recruiting NCT05772273
PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allo-HSCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azacitidine, Donor lymphocyte infusion, Camrelizumab.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Overview
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
- 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.
Primary outcome measures
- Overall response rate (ORR) [Time frame: ORR assessment is at day 39 (±2).]
Secondary outcome measures (3)
- Overall Survival (OS) [Time frame: 2 years]
- Progression-Free Survival (PFS) [Time frame: 2 years]
- Adverse events [Time frame: 1 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Soochow University — Suzhou
Identifiers
NCT: NCT05772273 · MA-AML-Ⅱ-002