Conditioning Regimen Before Infusion of Allogeneic Hemato... | NCT00770523

Studies
Conditioning Regimen Before Infusion of Allogeneic Hematopoietic Stem Cells

NCT00770523

Sponsor

Cooperative Study Group A for Hematology

Status

Completed

Last Update Posted

Jun 10, 2011Estimated

Enrollment

52Actual

Phase

Not provided

Conditions

HEMATOLOGIC MALIGNANCIES

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Mar 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Oct 5, 2008

First Submission Date that Met QC Criteria

Oct 9, 2008

First Posted Date

Oct 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2011

Last Update Posted Date

Jun 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
treatment-related mortality and engraftment		all cause mortality

Secondary Outcomes

Measure	Description	Time Frame
regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.		Time point(s) at which outcome measure is assessed.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

acute leukemia chronic myelogenous leukemia myelodysplastic syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyoo-hyung Lee, doctor	COSAH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		138-736	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided