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HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
idarubicin
microtransplantation
Sponsored by
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, idarubicin, Microtransplantation

Eligibility Criteria

7 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • The Affiliated Hospital of the Chinese Academy of Military Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

idarubicin

microtransplantation

Arm Description

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

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

Outcomes

Primary Outcome Measures

complete remission

Secondary Outcome Measures

disease-free survival
overall survival

Full Information

First Posted
December 1, 2011
Last Updated
July 12, 2016
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01484171
Brief Title
HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
Official Title
HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia, idarubicin, Microtransplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
idarubicin
Arm Type
Active Comparator
Arm Description
The patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine.
Arm Title
microtransplantation
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
idarubicin
Intervention Description
idarubicin 10-12 mg/m2 for three days
Intervention Type
Biological
Intervention Name(s)
microtransplantation
Intervention Description
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
Primary Outcome Measure Information:
Title
complete remission
Time Frame
one year
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
three years
Title
overall survival
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having signed informed consent Diagnosis was based on the French-American-British (FAB) and WHO criteria. Age ≥ 7 years old Age < 60 years old Exclusion Criteria: 1.Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
huisheng ai, Doctor of Medicine
Phone
86-01-66947126
Email
huishengai@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
huisheng ai, M.D.
Organizational Affiliation
The Affiliated Hospital of the Chinese Academy of Military Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of the Chinese Academy of Military Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
huisheng ai, M.D.
Phone
86-01-66947126
Email
huishengai@163.com
First Name & Middle Initial & Last Name & Degree
zheng dong, M.M
Phone
86-01-66947130
Email
dongz1983@139.com

12. IPD Sharing Statement

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HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

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