HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01484171
• Other study ID #: MST-AML-307PLAH-ASH
• Status: Recruiting
• Phase: Phase 3
• First received: December 1, 2011
• Last updated: July 12, 2016
• Start date: August 2011
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: huisheng ai, Doctor of Medicine
• Phone: 86-01-66947126
• Email: huishengai[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
China	The Affiliated Hospital of the Chinese Academy of Military Medical Science	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission		one year	Yes
Secondary	disease-free survival		three years	Yes
Secondary	overall survival		three years	Yes