acute myeloid leukemia
Conditions
Interventions
Group 2:Camrelizumab combined with Azacytidine
Group 1:Azacytidine chemotherapy combined with donor lymphocyte infusion
Sponsors
The Sixth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with relapsed acute myeloid leukemia who have previously received allogeneic hematopoietic stem cell transplantation; 2. Aged >= 16 years old; 3. ECOG = 3 months; 4. The recurrence time after allogeneic hematopoietic stem cell transplantation was at least 8 weeks; 5. The screening period has basic organ functions, which are defined as follows: 1) Serum creatinine (CR) = 60ml / min (Cockcroft Gault formula); 2) Bil <= 1.5 times of upper limit of normal value (ULN); 3) The level of AST / SGOT or ALT / SGPT was less than 3 times the upper limit of normal value (ULN); 4) INR <= 1.5, Pt and APTT <= 1.5-fold ULN; 6. Women of childbearing age should have urine or serum pregnancy. If urine test is positive or can not be confirmed as negative, serum pregnancy test is required; 7. Male and female subjects with fertility potential must agree to use appropriate contraceptive methods during and 120 days after treatment; 8. The subjects are willing to understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Received allogeneic hematopoietic stem cell transplantation within 8 weeks before signing the informed consent, and developed acute GVHD of level 3-4; 2. Patients who received DLI treatment within 4 weeks; 3. Have a history of immune deficiency, including positive serum test of human immunodeficiency virus (HIV), or suffer from other acquired and congenital immune deficiency diseases, and known subjects are in the active stage of tuberculosis; 4. Known active period of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV copies >= 2 * 10^3 IU / ml; HCV copies >= 1 * 10^3 IU / ml); 5. Clinical history of serious cardiovascular diseases, including: (1) congestive heart failure (NYHA class > 2); (2) Unstable angina pectoris; (3) myocardial infarction in the past year; (4) any arrhythmia requiring treatment or intervention; 6. The patient is participating in other clinical studies or is short of the end time of the previous clinical study 4 weeks; 7. Previously received PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody acting on T cell co stimulation or checkpoint access); 8. Known to be allergic to shr-1210 active ingredients or excipients; 9. Pregnant or lactating female patients; 10. The researcher judges other patients who may affect the clinical research, who may not comply with the agreement, who may not cooperate, and who may have research risks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| minimal residual disease;Lymphocyte subsets classification;Interleukin-2;Interleukin-4;donor cell chimerism (DCC);Interleukin-10;Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of patients with GVHD and other adverse reactions related to immunotherapy;Overall Survival, OS;Progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactYuanyuan Ma
Hematology Department of the Sixth Medical Center of PLA General Hospital
Outcome results
None listed