HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01484171

Enrollment

Registered

2011-12-02

Start date

2011-08-31

Completion date

2017-12-31

Last updated

2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, idarubicin, Microtransplantation

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).

Interventions

DRUGidarubicin

idarubicin 10-12 mg/m2 for three days

BIOLOGICALmicrotransplantation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
complete remission	one year

Secondary

Measure	Time frame
disease-free survival	three years
overall survival	three years

Countries

China

Contacts

Primary Contacthuisheng ai, Doctor of Medicine

huishengai@163.com86-01-66947126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026