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This project is a prospective, multicenter, randomized controlled clinical study. The subjects were refractory / relapsed AML patients aged ≤ 60 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The classical Bu / Cy scheme or MCBC scheme was used for pretreatment. The primary endpoint of the study was the 3-year recurrence-free survival rate after allogeneic hematopoietic stem cell transplantation, and the secondary endpoints were 3-year overall survival rate, recurrence rate, treatment-related mortality, and pretreatment-related toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control arm | Active Comparator | Busulfan/Cyclophosphamide, "standard" conditioning regimen as a control group. including Bu3.2mg/kg -5~-3d; Cy 80mg/kg,-2~-1d。 or alternative Bu/Cy regimen, Bu3.2mg/kg -9~-7d;Flu 30mg/m2 -6~-4d;Ara-C 2g/m2 -6~-4d;Cy 80mg/kg -3~-2d。 |
|
| MCBC group | Experimental | using MCBC as conditioning regimen, Mel 60mg/ m2 -9~-8d, Cladribine 5 mg/m2 -9~-5d, Bu3.2mg/kg -5~-3dï¼› Cy 30mg/kg -2~-1 d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCBC regimen | Drug | using MCBC as conditioning regimen, Mel 60mg/ m2 -9~-8d, Cladribine 5 mg/m2 -9~-5d, Bu3.2mg/kg -5~-3dï¼› Cy 30mg/kg -2~-1 d |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Free Survival | The AML relapse free survival post-HSCT | 3 year post-HSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The overall survival post-HSCT | 3 year post-HSCT |
| cumulative incidence relapse rate | cumulative incidence relapse rate post-HSCT |
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Inclusion Criteria:
Exclusion Criteria:
Have a history of cancer and have received any treatment for this tumor in the past 3 years. But remove superficial bladder cancer, skin basal cells or squamous cell carcinoma, cervical epithelium. Intraepithelial neoplasia ( CIN ) or prostatic intraepithelial neoplasia ( PIN ).
MPAL.
It is known that the serological reaction of HIV or active hepatitis C virus is positive.
The inability to cooperate with the requirements of research, treatment and monitoring due to mental illness or other conditions.
Pregnant patients or patients who could not take appropriate contraceptive measures during treatment.
Previously received hematopoietic stem cell transplantation.
Active heart disease, defined as one or more of the following :
Researchers evaluated that is not suitable for the group.
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Bu/Cy regimen | Drug | control group, the standard conditioning regimen Busulfan/Cyclophosphamide |
|
|
| 3 year post-HSCT |
| Non-relapse mortality | Non-relapse mortality post-HSCT | 3 year post-HSCT |
| toxicity of conditioning regimen | Adverse events as assessed by CTCAE to evaluate conditioning related toxicity | 24w post-HSCT |
| Immune reconstitution post-HSCT | Using lymphocyte subset panel to assess immune recovery post-HSCT | 24w post-HSCT |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |