relapse refractory acute myeloid leukemia
Conditions
Interventions
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Aged >18 years, with an expected survival period of more than 3 months; (2) Diagnostic criteria of recurrent AML: complete remission (CR) after re-emergence of leukemia cells or bone marrow primordial cells >0.050 (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration. Diagnostic criteria of refractory AML: The new diagnosed patient received no response after two courses of standard treatment; CR after consolidation and intensive treatment, recurrence within 12 months; relapse after 12 months but not treated by conventional chemotherapy; Recurrence more than twice; persisting extramedullary leukemia. (3) ECOG score = 2 points ; (4) tumor burden: 0.5x10^9/L, Hb =80 g/L, PLT =60×10^9/L), ALB=35g/L; (6) Cerebrospinal fluid and cranial magnetic resonance examination confirmed: leukemia cells did not invade the central nervous system; (7) Non-severe allergies; (8) There are no other serious diseases (such as autoimmune diseases, immunodeficiency, organ transplantation) that conflict with this program; (9) No history of other malignant tumors; (10) No serious mental disorders; (11) Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial and within 3 months after the trial; (12) The patient signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women; (2) Severe infectious diseases or viral diseases (HIV positive, syphilis, etc.); (3) Active hepatitis B or C virus; (4) Patients who have used a high dose of glucocorticoids within 1 week; (5) Those suffering from severe heart, liver, kidney dysfunction, diabetes and other diseases; (6) Patients who have not undergone chemotherapy or hematopoietic stem cell transplantation within 3 months before blood collection; (7) Those who have participated in other clinical studies in the past 3 months or who have been treated with other gene products; (8) It is known to be allergic to recombinant humanized mAb or any excipient ingredient; experienced a history of severe allergic disease ; (9) The investigator believes that the condition of the patient is not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;DOR;PFS;OS; | — |
Countries
China
Contacts
Public ContactZhen Wang
Henan Provincial People's Hospital
Outcome results
None listed