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HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

This study is currently recruiting participants.
Verified July 2016 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT01484171
First Posted: December 2, 2011
Last Update Posted: July 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
December 1, 2011
December 2, 2011
July 13, 2016
August 2011
August 2017   (Final data collection date for primary outcome measure)
complete remission [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01484171 on ClinicalTrials.gov Archive Site
  • disease-free survival [ Time Frame: three years ]
  • overall survival [ Time Frame: three years ]
Same as current
Not Provided
Not Provided
 
HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: idarubicin
    idarubicin 10-12 mg/m2 for three days
  • Biological: microtransplantation
    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
  • Active Comparator: idarubicin
    The patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine.
    Intervention: Drug: idarubicin
  • Experimental: microtransplantation
    The 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
    Intervention: Biological: microtransplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2017
August 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Having signed informed consent
  2. Diagnosis was based on the French-American-British (FAB) and WHO criteria.
  3. Age ≥ 7 years old
  4. Age < 60 years old

Exclusion Criteria:

1.Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia

Sexes Eligible for Study: All
7 Years to 60 Years   (Child, Adult)
No
Contact: huisheng ai, Doctor of Medicine 86-01-66947126 huishengai@163.com
China
 
 
NCT01484171
MST-AML-307PLAH-ASH
No
Not Provided
Not Provided
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Not Provided
Principal Investigator: huisheng ai, M.D. The Affiliated Hospital of the Chinese Academy of Military Medical Science
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP