HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: idarubicin; Biological: microtransplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01484171

MST-AML-307PLAH-ASH

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 7 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

idarubicin

Active Comparator group

Description:

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

Treatment:

Drug: idarubicin

microtransplantation

Experimental group

Description:

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

Treatment:

Biological: microtransplantation