HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01484171
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 76
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2011
• Anticipated Primary Completion Date: Aug 1, 2017
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. complete remission [one year]

Secondary Outcome Measures

1. disease-free survival [three years]

2. overall survival [three years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Hospital of the Chinese Academy of Military Medical Science	Beijing	Beijing	China	100071

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• ClinicalTrials.gov Identifier: NCT01484171
• Other Study ID Numbers: MST-AML-307PLAH-ASH
• First Posted: Dec 2, 2011
• Last Update Posted: Jul 13, 2016
• Last Verified: Jul 1, 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; Idarubicin

Study Results

No Results Posted as of Jul 13, 2016