Safety and Efficacy Study of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
NCT ID: NCT02171117
Last Updated: 2016-07-13
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
PHASE3
196 participants
INTERVENTIONAL
2014-03-31
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CT-group
standard induction and consolidation chemotherapy only, without microtransplantation
No interventions assigned to this group
MST-group
standard induction and consolidation chemotherapy with microtransplantation
microtransplantation
infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
HLA-mismatched donor peripheral stem cell infusion
Interventions
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microtransplantation
infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
HLA-mismatched donor peripheral stem cell infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients have not been treated before.
* Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2.
* Patients must have a HLA mismatched donor who should be able to provide informed consent.
* All genders and races are eligible.
* ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min
* By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range.
* Donors must be able to safely undergo leukapheresis.
Exclusion Criteria
* acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
* active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
* occurred stroke or intracranial hemorrhage within 6 months before randomization.
* Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
* There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA).
* Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection
* Any situation processed by the PI that will be damaged to the patients safety.
* Patients and / or authorized family member refuse to sign the consent.
* attend other clinical researchers in 3 months.
60 Years
85 Years
ALL
No
Sponsors
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The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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AI HUISEHNG, MD
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Academy of Military Medical Sciences
Locations
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Affiliated Hospital of Academy of Military Medical Sciences ,
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IMCG-EAML2014
Identifier Type: -
Identifier Source: org_study_id
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