HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
1 other identifier
interventional
50
1 country
1
Brief Summary
To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (AML).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2011
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 13, 2016
July 1, 2016
6 years
December 1, 2011
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete remission
one year
Secondary Outcomes (2)
disease-free survival
three years
overall survival
three years
Study Arms (2)
idarubicin
ACTIVE COMPARATORThe patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine.
microtransplantation
EXPERIMENTALThe patients will receive induction chemotherapy containing high dose of idarubicin in combination with cytarabine and follow by infusioning granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells
Interventions
idarubicin 10-12mg/m2 for four days. After chemotherapy infusion granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells following each of three cycles of high dose cytarabine chemotherapy
Eligibility Criteria
You may qualify if:
- Having signed informed consent
- Diagnosis was based on the French-American-British (FAB) and WHO criteria.
- Age ≥ 7 years old
- Age \< 60 years old
You may not qualify if:
- Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Hospital of the Chinese Academy of Military Medical Science
Beijing, Beijing Municipality, 100071, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
huisheng ai, M.D.
The Affiliated Hospital of the Chinese Academy of Military Medical Science
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2011
First Posted
December 2, 2011
Study Start
August 1, 2011
Primary Completion
August 1, 2017
Study Completion
December 1, 2017
Last Updated
July 13, 2016
Record last verified: 2016-07