Acute Myeloid Leukemia Clinical Trial
Official title:
Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia
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).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 65 Years |
Eligibility |
Inclusion Criteria: - AML patients who have received induction chemotherapy with moderate-high dose Ara-C and 3 courses consolidate chemotherapy - Intolerance or unwillingness of allogeneic HSCT - Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria: - Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) - Patients with any conditions not suitable for the trial (investigators' decision) |
Country | Name | City | State |
---|---|---|---|
China | Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University | Guangzhou First People's Hospital, Peking University People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital |
China,
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. Epub 2015 Feb 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CR rate | The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation | 2 years | |
Primary | relapse rate | 2 years | ||
Secondary | Overall Survival | 2 years | ||
Secondary | Disease-free Survival | 2 years | ||
Secondary | Incidence of chimerism | 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 |
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