Skip to main content
OpenTrials
Completed

NCT Number: NCT01674985

Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / 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

  • patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
  • International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
  • bone marrow blasts > 11% or <= 10% and poor cytogenetics;
  • lack of an HLA-identical donor;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • adequate cardiac and hepatorenal functions.

Exclusion criteria

  • have an HLA-identical donor

Treatment and study plan

Microtransplantation

Biological

Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)

Primary outcomes

  1. complete remission

    Time frame: six months

Secondary outcomes

  1. disease-free survival

    Time frame: three years

Other outcomes

  1. overall survival

    Time frame: three years

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Other

Collaborators

  • The Second Artillery General Hospital

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Aug 29, 2012
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.