Hematopoietic Stem Cell Microtransplantation for in AML
NCT ID: NCT02676856
Last Updated: 2017-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2016-02-29
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CR group
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.
hematopoietic stem cell microtransplantation-long-term
Stem cell infusion are administrated once three months for 3 times with the cell count of 3\*10\^8/kg/once.
Conditioning for CR group
For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).
Non-CR group
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.
hematopoietic stem cell microtransplantation-short-term
Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3\*10\^8/kg/once.
Conditioning for Non-CR group
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).
Interventions
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hematopoietic stem cell microtransplantation-long-term
Stem cell infusion are administrated once three months for 3 times with the cell count of 3\*10\^8/kg/once.
hematopoietic stem cell microtransplantation-short-term
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
For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).
Conditioning for Non-CR group
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with any conditions not suitable for the trial (investigators' decision)
14 Years
65 Years
ALL
No
Sponsors
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Guangzhou First People's Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Peking University People's Hospital
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Zhujiang Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Qifa Liu
Professor
Principal Investigators
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Qifa Liu
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Fen Huang
Role: primary
References
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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.
Other Identifiers
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Microtransplantation-AML-2016
Identifier Type: -
Identifier Source: org_study_id