National Marrow Donor Program Long-Term Donor Follow-Up

Hematologic Neoplasms Clinical Trial

— LTDFU  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362179
• Other study ID #: LTDFU
• Status: Completed
• Start date: October 2010
• Est. completion date: October 15, 2020

Study information

• Verified date: March 2020
• Source: Center for International Blood and Marrow Transplant Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21974
• Est. completion date: October 15, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Unrelated donor who donated either unstimulated BM or filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation.

2. 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.

3. Donation was managed by a U.S. NMDP donor center.

4. Signed informed consent for participation in this long-term donor follow-up study. Concurrent enrollment on other studies is permitted.

Exclusion Criteria:

1. Unrelated donor who donated filgrastim-mobilized bone marrow.

2. Donation was managed by a non-U.S. donor center.

3. Donor is unable to verbally communicate in any of the following languages: English, Spanish, Mandarin Chinese, Cantonese Chinese, Vietnamese, Korean, or Portuguese.

Related Conditions & MeSH terms

• Hematologic Neoplasms

Locations

Country	Name	City	State
Puerto Rico	National Marrow Donor Program at Puerto Rico	Guaynabo
United States	Community Blood Center, Inc.	Appleton	Wisconsin
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	New York Blood Center	Brooklyn	New York
United States	National Marrow Donor Program Southeast District	Charlotte	North Carolina
United States	Blood Assurance, Inc.	Chattanooga	Tennessee
United States	National Marrow Donor Program Northcentral District	Cleveland	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	Colorado Marrow Donor Program	Denver	Colorado
United States	City of Hope	Duarte	California
United States	Cook Children's	El Paso	Texas
United States	OneBlood	Fort Lauderdale	Florida
United States	LifeSource	Glenview	Illinois
United States	Michigan Blood	Grand Rapids	Michigan
United States	Hawaii Bone Marrow Donor Registry	Honolulu	Hawaii
United States	Gulf Coast Regional Blood Center	Houston	Texas
United States	Indiana Blood Center	Indianapolis	Indiana
United States	Cooperative Appalachian Marrow Program Medic Regional Blood Center	Knoxville	Tennessee
United States	National Marrow Donor Program Southcentral District, Heart of America	Leawood	Kansas
United States	DKMS Americas	New York	New York
United States	National Marrow Donor Program Northern California & Northwest District	Oakland	California
United States	Oklahoma Blood Institute	Oklahoma City	Oklahoma
United States	The HLA Registry	Oradell	New Jersey
United States	National Marrow Donor Program Northeast District	Philadelphia	Pennsylvania
United States	Rhode Island Blood Center	Providence	Rhode Island
United States	Rock River Valley Blood Center	Rockford	Illinois
United States	South Texas Blood and Tissue Center	San Antonio	Texas
United States	National Marrow Donor Program Southern California & Southwest District	Santa Ana	California
United States	Scott & White Clinic	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Center for International Blood and Marrow Transplant Research	National Marrow Donor Program

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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