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| Name | Class |
|---|---|
| Guangzhou First People's Hospital | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Peking University People's Hospital | OTHER |
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The purpose of this study is to evaluate the efficacy of hematopoietic stem cell microtransplantation for in acute myeloid leukemia (AML)patients who can not receive hematopoietic stem cell transplantation (HSCT).
Despite allogeneic HSCT is the only curative therapy for AML, some patients can not receive transplantation due to intolerance of transplant-related toxicity or unwillingness of HSCT. For these patients, microtransplantation seems an optional therapy. However, the efficacy still remain unclear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CR group | Experimental | For the patients in CR group(CR status of AML at microtransplantation), the conditioning regimen is high-dose (HD) Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with long-term course. |
|
| Non-CR group | Experimental | For the patients in Non-CR group (PR or NR status of AML at microtransplantation), the conditioning regimens include: IAC or HD Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with short-term course. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hematopoietic stem cell microtransplantation-long-term | Procedure | Stem cell infusion are administrated once three months for 3 times with the cell count of 3*10^8/kg/once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CR rate | The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation | 2 years |
| relapse rate | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 2 years | |
| Disease-free Survival | 2 years | |
| Incidence of chimerism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fen Huang | Contact | +86-020-62787883 | 13826204917@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26137066 | Background | Kong X, Chen Y, Wang LI, Zhou Y, He Y, Nie W, Zhang X, Yin X. Effect of the microtransplantation of allogeneic hematopoietic stem cells as maintenance therapy for elderly patients with acute leukemia. Oncol Lett. 2015 May;9(5):2331-2334. doi: 10.3892/ol.2015.2995. Epub 2015 Feb 27. |
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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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| Third Affiliated Hospital, Sun Yat-Sen University |
| OTHER |
| Zhujiang Hospital | OTHER |
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| hematopoietic stem cell microtransplantation-short-term | Procedure | Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3*10^8/kg/once. |
|
| Conditioning for CR group | Drug | For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3). |
|
| Conditioning for Non-CR group | Drug | For the patients in Non-CR group, the conditioning regimens include: IAC(IDA 12mg/m2 d1-3,Ara-C 200 mg/m2 d1-7, Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3). |
|
Incidence of chimerism will be evaluated in the patients. Both peripheral-blood cells and bone marrow are tested for hematopoietic donor chimerism by a standard cytogenetic analysis and a semiquantitative PCR-based analysis of the short tandem repeats.
| 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |