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HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

This study is currently recruiting participants.
Verified March 2013 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT01484171
First received: December 1, 2011
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
 Drug: idarubicin
Biological: microtransplantation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:

Primary Outcome Measures:
  • complete remission [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • disease-free survival [ Time Frame: three years ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 60 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 1, 2011
Last Updated: March 27, 2013
Health Authority: China: Ethics Committee

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, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Idarubicin
Lenograstim
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013