HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

July 12, 2016 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: huisheng ai, Doctor of Medicine
  • Phone Number: 86-01-66947126
  • Email: huishengai@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Recruiting
        • The Affiliated Hospital of the Chinese Academy of Military Medical Science
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: idarubicin
The patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine.
Drug: idarubicin
idarubicin 10-12 mg/m2 for three days
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete remission
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: three years
three years
overall survival
Time Frame: three years
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Investigators

  • Principal Investigator: huisheng ai, M.D., The Affiliated Hospital of the Chinese Academy of Military Medical Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 1, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (Estimate)

December 2, 2011

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MST-AML-307PLAH-ASH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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