NCT00770523

Brief Summary

Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning for Younger Patients with Hematologic Malignancies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

4.3 years

First QC Date

October 5, 2008

Last Update Submit

June 8, 2011

Conditions

Keywords

patients without comorbidity

Outcome Measures

Primary Outcomes (1)

  • treatment-related mortality and engraftment

    all cause mortality

Secondary Outcomes (1)

  • regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.

    Time point(s) at which outcome measure is assessed.

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

acute leukemia chronic myelogenous leukemia myelodysplastic syndrome

You may qualify if:

  • Patients should have an unrelated donor who is matched for HLA-A and -B by serology and for -DRB1 by molecular typing.

You may not qualify if:

  • Patients should not have major illness or organ failure
  • Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
  • Patients must not be pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Kyoo-hyung Lee, doctor

    COSAH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

October 5, 2008

First Posted

October 10, 2008

Study Start

December 1, 2003

Primary Completion

March 1, 2008

Study Completion

December 1, 2008

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations