Blood Samples to Identify Biomarkers in Haploidentical Gr... | NCT01141959

Studies
Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

NCT01141959

Sponsor

Fred Hutchinson Cancer Center

Status

Completed

Last Update Posted

May 31, 2023Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Leukemia
Hodgkin Disease
Non-Hodgkin Lymphoma
Myelodysplastic Syndrome
Multiple Myeloma

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
IR-7093	Other Identifier	FHCRC
R01HL091744-02S1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2015

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

May 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 8, 2010

First Submission Date that Met QC Criteria

Jun 10, 2010

First Posted Date

Jun 11, 2010Estimated

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

May 30, 2023

Last Update Posted Date

May 31, 2023Actual

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

The investigators are interested in identifying patient-specific factors related to donor chimerism in patients who receive nonmyeloablative hematopoietic stem cell transplants from haploidentical donors. We will look how patients' bodies break down and immediately respond to cyclophosphamide, fludarabine and mycophenolate mofetil.

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

11Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Exposure to cyclophosphamide, fludarabine, and mycophenolate mofetil and their breakdown products		1 week before through 3 weeks after transplant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled to receive nonmyeloablative conditioning which includes fludarabine
Scheduled to receive a haploidentical graft
Scheduled to receive postgrafting immunosuppression which includes oral mycophenolate mofetil (MMF) or enteric-coated mycophenolic acid
Age >18 years at the time of enrollment

Exclusion Criteria:

Diagnosed with an immunodeficiency disorder, including HIV

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

Hematopoeitic cell transplant patients with haploidentical donors receiving cyclophosphamide, fludarabine and mycophenolate mofetil.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeannine 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
D009101	Multiple Myeloma

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