Clinical trial NCT01362179: National Marrow Donor Program Long-Term Donor Follow-Up
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Neoplasms
Keywords: malignant myeloid hematologic disorders
filgrastim
long term incidence
donors who received and in those who did not receive filgrastim.
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
Collaborators: name: National Marrow Donor Program
First posted: 2011-05-30
Enrollment: 21974
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10,000 unstimulated BM donors and 20,000 filgrastim-mobilized PBSC donors

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of malignant myeloid hematologic disorders
timeFrame: Post HSCT donation
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Oakland
country: United States
facility: National Marrow Donor Program Northern California & Northwest District
state: California
city: Santa Ana
country: United States
facility: National Marrow Donor Program Southern California & Southwest District
state: California
city: Denver
country: United States
facility: Colorado Marrow Donor Program
state: Colorado
city: Fort Lauderdale
country: United States
facility: OneBlood
state: Florida
city: Honolulu
country: United States
facility: Hawaii Bone Marrow Donor Registry
state: Hawaii
city: Glenview
country: United States
facility: LifeSource
state: Illinois
city: Rockford
country: United States
facility: Rock River Valley Blood Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Blood Center
state: Indiana
city: Leawood
country: United States
facility: National Marrow Donor Program Southcentral District, Heart of America
state: Kansas
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Grand Rapids
country: United States
facility: Michigan Blood
state: Michigan
city: Oradell
country: United States
facility: The HLA Registry
state: New Jersey
city: Brooklyn
country: United States
facility: New York Blood Center
state: New York
city: New York
country: United States
facility: DKMS Americas
state: New York
city: Charlotte
country: United States
facility: National Marrow Donor Program Southeast District
state: North Carolina
city: Cleveland
country: United States
facility: National Marrow Donor Program Northcentral District
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Blood Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: National Marrow Donor Program Northeast District
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Blood Center
state: Rhode Island
city: Chattanooga
country: United States
facility: Blood Assurance, Inc.
state: Tennessee
city: Knoxville
country: United States
facility: Cooperative Appalachian Marrow Program Medic Regional Blood Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: El Paso
country: United States
facility: Cook Children's
state: Texas
city: Houston
country: United States
facility: Gulf Coast Regional Blood Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Blood and Tissue Center
state: Texas
city: Temple
country: United States
facility: Scott & White Clinic
state: Texas
city: Appleton
country: United States
facility: Community Blood Center, Inc.
state: Wisconsin
city: Guaynabo
country: Puerto Rico
facility: National Marrow Donor Program at Puerto Rico
Study officials:
affiliation: National Marrow Donor Program
name: John P Miller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: