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HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01484171
Recruitment Status : Recruiting
First Posted : December 2, 2011
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: idarubicin Biological: microtransplantation Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
Study Start Date : August 2011
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Active Comparator: idarubicin
The patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine.
Drug: idarubicin
idarubicin 10-12 mg/m2 for three days

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
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




Primary Outcome Measures :
  1. complete remission [ Time Frame: one year ]

Secondary Outcome Measures :
  1. disease-free survival [ Time Frame: three years ]
  2. overall survival [ Time Frame: three years ]


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Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484171


Contacts
Contact: huisheng ai, Doctor of Medicine 86-01-66947126 huishengai@163.com

Locations
China, Beijing
The Affiliated Hospital of the Chinese Academy of Military Medical Science Recruiting
Beijing, Beijing, China, 100071
Contact: huisheng ai, M.D.    86-01-66947126    huishengai@163.com   
Contact: zheng dong, M.M    86-01-66947130    dongz1983@139.com   
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
Principal Investigator: huisheng ai, M.D. The Affiliated Hospital of the Chinese Academy of Military Medical Science

Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT01484171     History of Changes
Other Study ID Numbers: MST-AML-307PLAH-ASH
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Acute Myeloid Leukemia
idarubicin
Microtransplantation

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Idarubicin
Lenograstim
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic