National Marrow Donor Program Long-Term Donor Follow-Up (LTDFU)

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)

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Neoplasms

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.

• Study Type: Observational
• Enrollment (Actual): 21974

Contacts and Locations

Study Locations

• Puerto Rico
  • Guaynabo, Puerto Rico, 00968-2710
    • National Marrow Donor Program at Puerto Rico
• United States
  • California
    • Duarte, California, United States, 91010-3012
      • City of Hope
    • Oakland, California, United States, 94612
      • National Marrow Donor Program Northern California & Northwest District
    • Santa Ana, California, United States, 92705
      • National Marrow Donor Program Southern California & Southwest District
  • Colorado
    • Denver, Colorado, United States, 80230-6918
      • Colorado Marrow Donor Program
  • Florida
    • Fort Lauderdale, Florida, United States, 33309
      • OneBlood
  • Hawaii
    • Honolulu, Hawaii, United States, 96817-1651
      • Hawaii Bone Marrow Donor Registry
  • Illinois
    • Glenview, Illinois, United States, 60025-2498
      • LifeSource
    • Rockford, Illinois, United States, 61107
      • Rock River Valley Blood Center
  • Indiana
    • Indianapolis, Indiana, United States, 46208-4437
      • Indiana Blood Center
  • Kansas
    • Leawood, Kansas, United States, 66206
      • National Marrow Donor Program Southcentral District, Heart of America
  • Massachusetts
    • Boston, Massachusetts, United States, 02115-6013
      • Dana-Farber Cancer Institute
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Michigan Blood
  • New Jersey
    • Oradell, New Jersey, United States, 07649
      • The HLA Registry
  • New York
    • Brooklyn, New York, United States, 11201
      • New York Blood Center
    • New York, New York, United States, 10016
      • DKMS Americas
  • North Carolina
    • Charlotte, North Carolina, United States, 28269
      • National Marrow Donor Program Southeast District
  • Ohio
    • Cleveland, Ohio, United States, 44131
      • National Marrow Donor Program Northcentral District
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-3251
      • Oklahoma Blood Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19123-3594
      • National Marrow Donor Program Northeast District
  • Rhode Island
    • Providence, Rhode Island, United States, 02908-4811
      • Rhode Island Blood Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403-1207
      • Blood Assurance, Inc.
    • Knoxville, Tennessee, United States, 37601
      • Cooperative Appalachian Marrow Program Medic Regional Blood Center
  • Texas
    • Dallas, Texas, United States, 75246-2029
      • Baylor Research Institute
    • El Paso, Texas, United States, 79913
      • Cook Children's
    • Houston, Texas, United States, 77054-1802
      • Gulf Coast Regional Blood Center
    • San Antonio, Texas, United States, 78201-2023
      • South Texas Blood and Tissue Center
    • Temple, Texas, United States, 76508-0001
      • Scott & White Clinic
  • Wisconsin
    • Appleton, Wisconsin, United States, 54914-9106
      • Community Blood Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
unstimulated BM donors; Observational (non-interventional) study.
filgrastim-mobilized PBSC donors; Observational (non-interventional) study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborators: National Marrow Donor Program
• Investigators: Principal Investigator: John P Miller, MD, PhD, National Marrow Donor Program

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: May 27, 2011
• First Posted (Estimate): May 30, 2011

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: filgrastim; malignant myeloid hematologic disorders; long term incidence; donors who received and in those who did not receive filgrastim.
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: LTDFU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No