Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Condition(s) targeted: Healthy

Intervention: Filgrastim (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Center for International Blood and Marrow Transplant Research

Official(s) and/or principal investigator(s):
John P Miller, MD, PhD, Principal Investigator, Affiliation: National Marrow Donor Program

Overall contact:
Tasha Spawn, Phone: 612-884-8731, Email: tspawn@nmdp.org

The purpose of the study is to:

- Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood

stem cells from National Marrow Donor Program donors (NMDP) donors

- Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis

- Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor

hematopoietic stem cell transplant recipients

- Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in

normal donors

Official title: Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

Study design: Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors.

Secondary outcome:

Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis

Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients

Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors

Detailed description: For many years, allogeneic bone marrow transplantation has been used to successfully treat leukemias, other hematologic conditions and congenital disorders. The first unrelated donor transplants were performed in the late 1970s, but this procedure did not become widely available until the development of several consolidated unrelated donor registries around the world. The National Marrow Donor Program, established in 1987, is the world's largest registry and currently lists more than 7 million donors. Since its beginning, NMDP has facilitated more than 30,000 unrelated transplants.

Although not a licensed indication, considerable experience has been accumulated concerning administration of filgrastim to normal adults. Most of these adults were volunteer research subjects or donors of PBSC for use in related donor transplants. Beginning in February 1997, filgrastim stimulated PBSC have been collected from NMDP donors under protocol. The protocol (locally referred to as G2) began under an NMDP-sponsored Investigational New Drug (IND) application filed with FDA for collecting PBSC for a second donation following an initial donation of bone marrow. In 1999 a second protocol was opened (locally referred to as G1) as requests for PBSC as a primary donation source became more common. In 2005 the two protocols were combined to eliminate redundancy and provide for ease of use.

The protocol establishes and evaluates a system to supply peripheral blood stem cell (PBSC) products for use in unrelated donor hematopoietic stem cell (HSC) transplantation. The protocol describes processes for donor identification, education and evaluation. Procedures for administration and monitoring of the stem cell mobilizing agent filgrastim are included. The protocol also describes procedures for the collection of PBSC products by leukapheresis and includes provisions for long term donor follow-up.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set

forth in NMDP Standards and the Donor Center Manual of Operations.

Exclusion Criteria:

- Pregnancy or uninterruptible breastfeeding. Pregnancy is an absolute contraindication

under this protocol. Women who are breastfeeding must be willing and able to interrupt breastfeeding during the administration of filgrastim and for two days following the final dose.

- Sensitivity to filgrastim or to E. coli-derived recombinant protein products.

- History of autoimmune disorders, including rheumatic diseases and thyroid disorders.

Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.

- History of deep vein thrombosis or pulmonary embolism.

- History of iritis or episcleritis.

- Thrombocytopenia < 150 x 10(9)/L (< 150,000/µL) at baseline evaluation.

- Current treatment with lithium. Drug interactions between filgrastim and lithium,

which may potentiate the release of neutrophils, have not been fully evaluated.

- Positive Hemoglobin-Solubility (e. g., SickleDex™ or equivalent) test.

- Donors receiving experimental therapy or investigational agents.

Tasha Spawn, Phone: 612-884-8731, Email: tspawn@nmdp.org

NMDP at Puerto Rico, Guaynabo 00968, Puerto Rico; Recruiting

City of Hope National Medical Center, Duarte, California 91010, United States; Recruiting

NMDP at Northern California & Northwest District, Oakland, California 94612, United States; Recruiting

Blood Bank of San Bernardino & Riverside Cts., San Bernadino, California 92408, United States; Recruiting

San Diego Blood Bank, San Diego, California 92103, United States; Recruiting

NMDP Southern California & Southwest District, Santa Ana, California 92705, United States; Recruiting

Colorado Marrow Donor Program, Denver, Colorado 80230, United States; Recruiting

NMDP Northeast District - New England Office, West Hartford, Connecticut 06110, United States; Recruiting

NMDP Southeast District - Washington D.C. Office, Washington D.C., District of Columbia 20004, United States; Recruiting

Gift of Life Bone Marrow Foundation, Boca Raton, Florida 33431, United States; Recruiting

LifeSouth Community Blood Centers, Gainesville, Florida 32607, United States; Recruiting

Community Blood Centers of So. Florida, Inc., Lauderhill, Florida 33313, United States; Recruiting

Florida's Blood Centers, Inc., Orlando, Florida 32809, United States; Recruiting

Florida Blood Services, Inc., St. Petersburg, Florida 33716, United States; Recruiting

Hawaii Bone Marrow Donor Registry, Honolulu, Hawaii 96817, United States; Recruiting

LifeSource, Glenview, Illinois 60025, United States; Recruiting

Rock River Valley Blood Center, Rockford, Illinois 61107, United States; Recruiting

Community Blood Services of Illinois, Urbana, Illinois 61801, United States; Recruiting

Indiana Blood Center, Indianapolis, Indiana 46208, United States; Recruiting

Iowa Marrow Donor Program, Iowa City, Iowa 52242, United States; Recruiting

NMDP Southcentral District, Heart of America Donor Center, Leawood, Kansas 66206, United States; Recruiting

James Graham Brown Cancer Center, Louisville, Kentucky 40202, United States; Recruiting

NIH Marrow Donor Center, Rockville, Maryland 20892, United States; Recruiting

C.W. Bill Young Marrow Donor Center, Rockville, Maryland 20852, United States; Recruiting

Dana Farber/Partners Cancer Care, Boston, Massachusetts 02115, United States; Recruiting

The Caitlin Raymond International Registry, Worcester, Massachusetts 01655, United States; Recruiting

NMDP Northcentral District - Michigan Office, East Lansing, Michigan 48823, United States; Recruiting

Michigan Community Blood Centers, Grand Rapids, Michigan 49501, United States; Recruiting

NMDP Northcentral District - Minnesota Office, Minneapolis, Minnesota 55413, United States; Recruiting

Mississippi Marrow Donor Program, Jackson, Mississippi 39216, United States; Recruiting

The HLA Registry, Oradell, New Jersey 07649, United States; Recruiting

New York Blood Center, Brooklyn, New York 11201, United States; Recruiting

DKMS Americas, New York, New York 10016, United States; Recruiting

NMDP Northeast District - Greater NY State Office, Rochester, New York 14607, United States; Recruiting

NMDP Southeast District, Charlotte, North Carolina 28269, United States; Recruiting

NMDP Northcentral District, Cleveland, Ohio 44131, United States; Recruiting

Community Blood Center, Dayton, Ohio 45402, United States; Recruiting

Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, Oklahoma 73104, United States; Recruiting

NMDP Northern California & Northwest District - Oregon Office, Portland, Oregon 97210, United States; Recruiting

NMDP Northeast District, Philadelphia, Pennsylvania 19123, United States; Recruiting

Central Blood Bank, Pittsburgh, Pennsylvania 15220, United States; Recruiting

Rhode Island Blood Center, Providence, Rhode Island 02908, United States; Recruiting

Blood Assurance, Inc., Chattanooga, Tennessee 37403, United States; Recruiting

Cooperative Appalachian Marrow Program, Johnson City, Tennessee 37604, United States; Recruiting

Carter BloodCare, Bedford, Texas 76021, United States; Recruiting

Baylor University Medical Center, Dallas, Texas 75246, United States; Recruiting

Cook Children's Medical Center, Fort Worth, Texas 76104, United States; Recruiting

Gulf Coast Regional Blood Center, Houston, Texas 77054, United States; Recruiting

South Texas Blood and Tissue Center, San Antonio, Texas 78201, United States; Recruiting

Scott & White Clinic, Temple, Texas 76508, United States; Recruiting

NMDP Southeast District - Virginia Office, Richmond, Virginia 23229, United States; Recruiting

Puget Sound Blood Center, Seattle, Washington 98104, United States; Recruiting

Inland Northwest Blood Center, Spokane, Washington 99201, United States; Recruiting

Community Blood Center, Inc., Appleton, Wisconsin 54914, United States; Recruiting

The Blood Center of Wisconsin, Milwaukee, Wisconsin 53233, United States; Recruiting

Donors from this study are drawn from members on the Be The Match Registry who are a possible match for a patient who needs a transplant. If you are interested in becoming a member click on the link and read more about our program.

Starting date: February 1997
Last updated: September 25, 2012