Refractory / Relapsed AML
Conditions
Interventions
Single group:Mel, Cladribine, Bu and Cy
Sponsors
Hematology Hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
15 Years to 59 Years
Inclusion criteria
Inclusion criteria: Subjects who are suitable for this study must meet all of the following criteria: 1. Refractory / recurrent AML patients confirmed by bone marrow morphology, immunology and genetics.In this study, the definition of refractory / recurrent AML is as follows. Refractory AML meets one of the following conditions: (1) newly treated cases who are ineffective after 2 courses of chemotherapy with standard regimen; (2) after consolidation and intensive treatment after CR, recurrence occurred within 12 months; (3) recurrence occurred after 12 months but ineffective conventional chemotherapy; (4) 2 or more relapses; (5) persistent extramedullary leukemia. Definition of recurrent AML: leukemic cells reappear in peripheral blood or bone marrow primordial cells > 0.05 or extramedullary leukemic cell infiltration was found after CR; 2. Recipients of allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic Hematopoietic stem cell transplantation and unrelated donor transplantation); 3. Aged 15 to 60 years old, male or female; 4. The physical status assessment (ECOG-PS) of the Eastern Cooperative Oncology Group was 0 Mel 2; 5. An informed consent form must be signed before the start of the research process. For those aged 18 or above, the informed consent form shall be signed by the patient himself or the immediate family member. The informed consent form shall be signed by the legal guardian for children and young patients under the age of 18. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease,the informed consent form shall be signed by the legal guardian or the immediate family member of the patient.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria shall not be enrolled in this study: 1. Has a history of cancer and has received any treatment for this tumor in the past 3 years, but excluding superficial bladder cancer, basal cells of the skin or squamous cell carcinoma, cervical intraepithelial carcinogenesis (CIN) or prostatic intraepithelial carcinomatosis (PIN); 2. It is known that the serological reaction of HIV or active hepatitis C virus is positive; 3. Suffering from mental illness or other conditions and unable to meet the requirements of research, treatment and monitoring; 4. Patients who are pregnant or who are unable to take appropriate contraceptive measures during treatment; 5. Received hematopoietic stem cell transplantation in the past year; 6. Active heart disease is defined as one or more of the following: 1) History of uncontrolled or symptomatic angina pectoris; 2) Myocardial infarction less than 6 months after study; 3) History of arrhythmia requiring medication or severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (> NYHA 2); 5) Ejection fraction below the lower limit of the normal range; 7. The researchers believe that it is not suitable for those who join the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood routine;peripheral blood smear;bone marrow swear;peripheral immune cell subsets;immunoglobulin quantification;cytokine;chimera;minimal residual disease;WT1 gene;gene mutation; | — |
Secondary
| Measure | Time frame |
|---|---|
| urine routine;blood coagulation function;blood biochemistry; | — |
Countries
China
Contacts
Public ContactErlie Jiang
Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
Outcome results
None listed