HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

NCT ID: NCT01484171

Last Updated: 2016-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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idarubicin

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

Group Type ACTIVE_COMPARATOR

idarubicin

Intervention Type DRUG

idarubicin 10-12 mg/m2 for three days

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

Group Type EXPERIMENTAL

microtransplantation

Intervention Type BIOLOGICAL

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

Interventions

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idarubicin

idarubicin 10-12 mg/m2 for three days

Intervention Type DRUG

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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huisheng ai, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of the Chinese Academy of Military Medical Science

Locations

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The Affiliated Hospital of the Chinese Academy of Military Medical Science

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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huisheng ai, Doctor of Medicine

Role: CONTACT

86-01-66947126

Facility Contacts

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huisheng ai, M.D.

Role: primary

86-01-66947126

zheng dong, M.M

Role: backup

86-01-66947130

Other Identifiers

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MST-AML-307PLAH-ASH

Identifier Type: -

Identifier Source: org_study_id

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