National Marrow Donor Program Long-Term Donor Follow-Up | NCT01362179

Official Title

Incidence of Hematologic and Non-Hematologic Malignancies, Thrombotic Events, and Autoimmune Disorders in Unrelated Normal Donors Undergoing Bone Marrow Harvest Versus Peripheral Blood Stem Cell Mobilization With Recombinant Human Granulocyte Colony-Stimulating Factor (rHuG-CSF)

Status Module

Record Verification Date

Mar 2020

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

Oct 2010

Primary Completion Date

Sep 30, 2020Actual

Completion Date

Oct 15, 2020Actual

First Submitted Date

May 26, 2011

First Submission Date that Met QC Criteria

May 27, 2011

First Posted Date

May 30, 2011Estimated

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

Oct 19, 2020

Last Update Posted Date

Oct 20, 2020Actual

Name	Class
National Marrow Donor Program	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Detailed Description

This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized PBSC donors. Donors will undergo biennial surveys until study completion. Cases of targeted disorders will be reviewed by the medical monitors to confirm the veracity of the report.

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

21,974Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
unstimulated BM donors		Observational (non-interventional) study.
filgrastim-mobilized PBSC donors		Observational (non-interventional) study.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of malignant myeloid hematologic disorders	To describe the long-term incidence of malignant myeloid hematologic disorders in donors who received and in those who did not receive filgrastim.	Post HSCT donation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unrelated donor who donated either unstimulated BM or filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation.
Unrelated donor who received at least one injection of filgrastim or more, but did not donate filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation.
Donation was managed by a U.S. NMDP donor center.
Signed informed consent for participation in this long-term donor follow-up study. Concurrent enrollment on other studies is permitted.

Exclusion Criteria:

Unrelated donor who donated filgrastim-mobilized bone marrow.
Donation was managed by a non-U.S. donor center.
Donor is unable to verbally communicate in any of the following languages: English, Spanish, Mandarin Chinese, Cantonese Chinese, Vietnamese, Korean, or Portuguese.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

10,000 unstimulated BM donors and 20,000 filgrastim-mobilized PBSC donors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John P Miller, MD, PhD	National Marrow Donor Program	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope		Duarte	California	91010-3012	United States
National Marrow Donor Program Northern California & Northwest District

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

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