Refractory / relapsed acute myeloid leukemia
Conditions
Interventions
Experimental group:Conditioning regimen consisted of thiotepa, cyclophosphamide and bulsulfan (TBC)
Sponsors
Soochow Hopes Hematonosis Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 69 Years
Inclusion criteria
Inclusion criteria: Subjects eligible to be enrolled in this study must meet all of the following criteria: 1. The patients are diagnosed refractory/relapsed acute myeloid leukemia confirmed by morphology, immunology and genetics of bone marrow morphology. 2. Recipients of allogeneic hematopoietic stem cell transplantation (including HLA-compatible or mismatched allogeneic hematopoietic stem cell transplantation and unrelated donor transplantation). 3. Age = 15 years old and <70 years old, both males and females. 4. The performance status assessment according to the Eastern Cooperative Oncology Group (ECOG-PS) was 0-2. 5. Informed consent must be signed before starting the study procedure. For those aged 18 and above, the informed consent should be signed by the patient himself or his immediate family. The legal guardian shall sign the informed consent for children and adolescents 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 legal guardian or the patient's immediate family members should sign the informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be included in this study: 1. Those who have a history of tumor and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer, basal layer or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN); 2. Known serologic positivity for HIV or active hepatitis C virus; 3. Suffers from a mental disorder or other medical condition and is unable to comply with the requirements of research treatment and monitoring; 4. Pregnant patients or patients unable to take appropriate contraceptive measures during treatment; 5. Those who have received hematopoietic stem cell transplantation within the past 1 year; 6. Active heart disease, defined as one or more of the following: 1) A history of uncontrolled or symptomatic angina; 2) Myocardial infarction within less than 6 months before enrollment; 3) A history of arrhythmia requiring drug therapy or severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (> NYHA level 2); 5) Ejection fraction was lower than the lower limit of the normal range. 7. Those who were considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Rate of relapse;Transplantation related mortality;Rate of Graft versus host disease (GVHD); | — |
Countries
China
Contacts
Public ContactWu Xiaojin
Soochow Hopes Hematonosis Hospital
Outcome results
None listed