Know Cancer

or
forgot password

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)


N/A
18 Years
60 Years
Open (Enrolling)
Both
Hematologic Neoplasms

Thank you

Trial Information

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. 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.


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

3. Signed informed consent for participation in this long-term donor follow-up study.

4. Concurrent enrollment on other studies is permitted (e.g. A Phase III Randomized
Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow
Transplantation from HLA Compatible Unrelated Donors (BMT CTN PvM Protocol 0201) and
A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life
(RDSafe).

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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Principal Investigator

John P Miller, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Marrow Donor Program

Authority:

United States: Federal Government

Study ID:

LTDFU

NCT ID:

NCT01362179

Start Date:

October 2010

Completion Date:

October 2020

Related Keywords:

  • Hematologic Neoplasms
  • malignant myeloid hematologic disorders
  • filgrastim
  • long term incidence
  • donors who received and in those who did not receive filgrastim.
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
New York Blood CenterNew York, New York  10021
City of HopeDuarte, California  91010
Baylor Research InstituteDallas, Texas  75246
The Johns Hopkins HospitalBaltimore, Maryland  21205
Puget Sound Blood CenterSeattle, Washington  98014
Colorado Marrow Donor ProgramDenver, Colorado  80230
Hawaii Bone Marrow Donor RegistryHonolulu, Hawaii  96817
LifeSourceGlenview, Illinois  60025
Rock River Valley Blood CenterRockford, Illinois  61107
Indiana Blood CenterIndianapolis, Indiana  46208
NIH Marrow Donor CenterRockville, Maryland  20892
The HLA RegistryOradell, New Jersey  07649
DKMS AmericasNew York, New York  10016
Rhode Island Blood CenterProvidence, Rhode Island  02908
Blood Assurance, Inc.Chattanooga, Tennessee  37403
Gulf Coast Regional Blood CenterHouston, Texas  77054
South Texas Blood and Tissue CenterSan Antonio, Texas  78201
Scott & White ClinicTemple, Texas  76508
Community Blood Center, Inc.Appleton, Wisconsin  54914
National Marrow Donor Program Northern California & Northwest DistrictOakland, California  94612
National Marrow Donor Program Southern California & Southwest DistrictSanta Ana, California  92705
Community Blood Centers of Florida, Inc.Lauderhill, Florida  33313-5006
National Marrow Donor Program Southcentral District, Heart of AmericaLeawood, Kansas  66206
Michigan BloodGrand Rapids, Michigan  49503
National Marrow Donor Program Southeast DistrictCharlotte, North Carolina  28269
National Marrow Donor Program Northcentral DistrictCleveland, Ohio  44131
Oklahoma Blood InstituteOklahoma City, Oklahoma  73104-3251
National Marrow Donor Program Northeast DistrictPhiladelphia, Pennsylvania  19123-3594
Cooperative Appalachian Marrow Program Medic Regional Blood CenterKnoxville, Tennessee  37601
Cook Children'sEl Paso, Texas  79913