Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.
The optimal therapy for intermediate-risk patients with acute myeloid leukemia (AML) in first complete remission (CR1) is uncertain. Recent studies shown that microtransplantation (MST) can improve survival in AML-CR1 patients. However, a comparison study between the MST and nonmyeloablative stem cell transplantation (NST) is lacking. 156 intermediate-risk AML-CR1 patients aged 9 to 59 years were enrolled in this study. Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MST(microtransplantation) | Experimental | The microtransplantation conditioning regimen included high-dose Ara-C chemotherapy (2.0 to 2.5 g/m2 per 12 hours intravenously on days -4 to -2) followed by an infusion of HLA mismatched stem cell 24 hours (day 0) after the completion of cytarabine. |
|
| NST(nonmyeloablative transplantation) | Active Comparator | The NST(nonmyeloablative transplantation)conditioning regimen consisted of 30 mg/m2/d fludarabine for days -6 to -2, 1.5-2 mg/kg/d anti-lymphocyte globulin for days -5 to -2, 40 mg/kg/d cyclophosphamide for days -4 and -2 and 2.0-3.0 g/m2/d cytarabine for days -6 to -4,followed by an infusion of HLA matched stem cell after the completion of regimen. The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLA mismatched stem cell | Genetic | HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| treatment-related mortality | 2 years | |
| donor chimerism or microchimerism | 10 years | |
| WT1+CD8+CTL |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ai huisheng | 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 , | Beijing | Beijing Municipality | 100071 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| HLA matched stem cell | Genetic | HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen |
|
|
| cyclosporine A | Drug | The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil |
|
|
| Mycophenolate mofetil | Drug | The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil |
|
|
| Ara-C | Drug | 2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose |
|
|
| fludarabine | Drug | 30 mg/m2/d for 5days |
|
|
| anti-lymphocyte globulin | Drug | 1.5-2 mg/kg/d for 4 days |
|
|
| cyclophosphamide | Drug | 40 mg/kg/d for 2 days |
|
|
donor versus leukemia effect
| 10 years |
| GVHD | 10 years |
| disease free survival | 10 years |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D003561 | Cytarabine |
| C024352 | fludarabine |
| D000961 | Antilymphocyte Serum |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided