HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

Phase 3

• Conditions: Acute Myeloid Leukemia
• Interventions: Biological: microtransplantation; Drug: idarubicin

• Registration Number: NCT01484171
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microtransplantation	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
idarubicin	idarubicin	The patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine.

Primary Outcome Measures

Name	Time	Method
complete remission	one year

Secondary Outcome Measures

Name	Time	Method
overall survival	three years
disease-free survival	three years

Trial Locations

Locations (1)

The Affiliated Hospital of the Chinese Academy of Military Medical Science; 🇨🇳 Beijing, Beijing, China