Blood Samples to Evaluate Biomarkers of Donor Chimerism | NCT00764829

Studies
Blood Samples to Evaluate Biomarkers of Donor Chimerism

NCT00764829

Sponsor

Fred Hutchinson Cancer Center

Status

Completed

Last Update Posted

Feb 15, 2012Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Leukemia
Hodgkins Disease
Non-hodgkins Lymphoma
Myelodysplastic Syndrome

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
R01HL091744	U.S. NIH Grant/Contract		View source
IR-5957	Other Identifier	FHCRC

Status Module

Record Verification Date

Feb 2012

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

Sep 2008

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Sep 30, 2008

First Submission Date that Met QC Criteria

Sep 30, 2008

First Posted Date

Oct 2, 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

Feb 13, 2012

Last Update Posted Date

Feb 15, 2012Estimated

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

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

We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body.

Detailed Description

Not provided

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

Retention

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Donor T-cell chimerism		Day 28 post-transplant

Secondary Outcomes

Measure	Description	Time Frame
Exposure to fludarabine and mycophenolate mofetil and their breakdown products.		Before and after transplant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with a hematologic disease or malignancy
Scheduled to receive nonablative conditioning with fludarabine and total body irradiation
Donor is well-matched by high resolution DNA techniques.
Scheduled to receive postgrafting immunosuppression of oral MMF (CellCept) and an oral calcineurin inhibitor.
Age >18 years at the time of enrollment.

Exclusion criteria:

-Diagnosed with an immunodeficiency disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hematopoietic stem cell transplant patients receiving fludarabine and mycophenolate mofetil.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeannine S McCune, PharmD	Fred Hutchinson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fred Hutchinson Cancer Research Center		Seattle	Washington	98109	United States

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D006689	Hodgkin Disease
D008228	Lymphoma, Non-Hodgkin
D009190	Myelodysplastic Syndromes

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided