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Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are randomly assigned to standard induction and consolidation chemotherapy with microtransplantation (MST-group)or without (CT-group).Compare the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate of the two groups.
Microtransplantation, which combines chemotherapy with adoptive infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC). Data from more than 70 elderly AML patients who received microtransplantation in Beijing showed that the remission rate and 2-year disease-free survival (DFS) reach 75-82% and 32-39% respectively, and microchimerisms (donor cells<1%) were detected without GVHD. The results have been clinically validated in several other centers in China, United States and Australia. Based on these facts, to further validate the therapeutic efficacy, we propose a phase III clinical trial in which the de novo AML patients ≥60 years old are randomly assigned to receive standard induction and consolidation chemotherapy with or without microtransplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-group | No Intervention | standard induction and consolidation chemotherapy only, without microtransplantation | |
| MST-group | Experimental | standard induction and consolidation chemotherapy with microtransplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microtransplantation | Procedure | infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| the remission rate | ①bone marrow: blasts <5% (with a count of at least 200 Nucleated cells).②Hemogram: absolute neutrophil count of more than 1.0×109/L,platelets of >100×109/L. ③Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion; | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | Measured from complete remission to the date of death or the date of last follow-up examination; | 2 years |
| Overall Survival | measured from the Date of beginning therapy to the date of death or the date of last follow-up examination; |
| Measure | Description | Time Frame |
|---|---|---|
| treatment-related mortality | Early mortality: death within 4 weeks after initiation of induction therapy | 2 years |
| donor chimerism or microchimerism | at count recovery prior to each new cycle of therapy, at 4 weeks after the last round of consolidation, and if still positive, every 3 months after completing therapy for up to 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AI HUISHENG, MD | Contact | 86-1066947126 | HUISHENGAI@163.COM |
| Name | Affiliation | Role |
|---|---|---|
| AI HUISEHNG, MD | Affiliated Hospital of Academy of Military Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Academy of Military Medical Sciences , | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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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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| HLA-mismatched donor peripheral stem cell infusion | Biological |
|
| 2 YEAR |
| donor versus leukemia effect | Analysis of donor WT1 positive CD8 T cells by flow cytometry | 2 years |
| recipient versus leukemia effect | Analysis of recipient WT1 positive CD8 T cells by flow cytometry | 2 YEAR |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |