Conditioning Regimen Before Infusion of Allogeneic Hematopoietic Stem Cells

HEMATOLOGIC MALIGNANCIES Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770523
• Other study ID #: C-004
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2008
• Last updated: June 8, 2011
• Start date: December 2003
• Est. completion date: December 2008

Study information

• Verified date: June 2011
• Source: Cooperative Study Group A for Hematology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

Primary end points are treatment-related mortality and engraftment. Secondary end points are regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• HEMATOLOGIC MALIGNANCIES
• Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Study Group A for Hematology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment-related mortality and engraftment		all cause mortality	No
Secondary	regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.		Time point(s) at which outcome measure is assessed.	No