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Completed

NCT Number: NCT02831192

Microtransplantation in Older Patients With Acute Myeloid Leukemia

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Affiliated Hospital of Academy of Military Medical Sciences ,

Beijing, Beijing Municipality, 100071, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microtransplantation

Biological

HLA mismatched donor mobilized prepheral stem cell infusion

Primary outcomes

  1. Graft versus host disease

    Time frame: 1 month

Secondary outcomes

  1. overall survival

    Time frame: 2 years

  2. leukemia free survival

    Time frame: 2 years

  3. complete remission rate

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Other

Registry information

Official study title

International Multi-center Clinical Study on Microtransplantation for Treatment of Newly Diagnosed Elderly Acute Myeloid Leukemia (EAML)

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2016
Registry last updated
Jul 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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