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Microtransplantation in Older Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02831192
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief Summary:
The purpose of this study is to see whether HLA-mismatched donor cells infusion with chemotherapy (microtransplantation,MST) could increase complete remission (CR) and improve survival in older patients with acute myeloid leukemia (AML),the investigators conducted a prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and toxicities.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: microtransplantation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Multi-center Clinical Study on Microtransplantation for Treatment of Newly Diagnosed Elderly Acute Myeloid Leukemia (EAML)
Study Start Date : May 2006
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015


Arm Intervention/treatment
Experimental: MST(microtransplantation) Biological: microtransplantation
HLA mismatched donor mobilized prepheral stem cell infusion




Primary Outcome Measures :
  1. Graft versus host disease [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]
  2. leukemia free survival [ Time Frame: 2 years ]
  3. complete remission rate [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • de novo acute myeloid leukemia
  • age 60-90
  • have HLA mismatched donor

Exclusion Criteria:

  • have no suitable donor or donor refused
  • patient refused to accept donor cells

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831192


Locations
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China, Beijing
Affiliated Hospital of Academy of Military Medical Sciences ,
Beijing, Beijing, China, 100071
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
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Study Chair: AI huisheng, MD Affiliated Hospital of Academy of Military Medical Sciences

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Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02831192    
Other Study ID Numbers: EAML-MST
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms