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Status unknownNCT01484171Updated Jul 13, 2016

HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

A Phase 3 interventional study of idarubicin and microtransplantation in Acute Myeloid Leukemia, sponsored by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences. Status unknown at 1 site in China. Open to participants aged 7 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-07-13.

Sponsored by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
7 Years to 60 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Acute Myeloid Leukemia

Keywords

  • Acute Myeloid Leukemia
  • idarubicin
  • Microtransplantation
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In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's planned enrollment of 50 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.

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Lead sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

1.Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    idarubicin

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

    Drug: idarubicin

  • Experimental
    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

    Biological: microtransplantation

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

06

What researchers measure

Primary outcomes

  1. complete remission

    Time frame: one year

Secondary outcomes

  1. disease-free survival

    Time frame: three years

  2. overall survival

    Time frame: three years

07

Study locations

1 of 1 sites recruiting
  • The Affiliated Hospital of the Chinese Academy of Military Medical Science
    Beijing, Beijing 100071, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01484171
Lead sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Responsible party
Sponsor
First posted
Dec 2, 2011
Start date
Aug 2011
Primary completion
Aug 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Jul 13, 2016

Study contacts

huisheng ai, Doctor of Medicine
Contact
huishengai@163.com
86-01-66947126
huisheng ai, M.D.
principal investigator · The Affiliated Hospital of the Chinese Academy of Military Medical Science

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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