NIH Clinical Research Studies

Protocol Number: 00-CC-0165

Active Accrual, Protocols Recruiting New Patients

Title:
Filgrastim-Mobilized Peripheral Blood Stem Cells for Primary Allogeneic Transplantation Using Unrelated Donors Participating in the National Marrow Donor Program (NMDP)
Number:
00-CC-0165
Summary:
This study will test whether stem cells collected from the bloodstream (peripheral blood stem cells) can be used instead of cells collected from bone marrow for unrelated donor transplantation. Stem cells are cells produced by the bone marrow that mature into the various blood components-white and red blood cells and platelets.

Unlike bone marrow, the bloodstream contains few stem cells. Therefore, donors are given G-CSF (also called filgrastim)-a growth factor naturally produced by the body-before cell collection. G-CSF boosts bone marrow production of stem cells and mobilizes them to enter the bloodstream, allowing enough cells to be collected for transplantation. G-CSF-mobilized blood stem cells are often used for transplantation in recipients who are related to their donors. This study will evaluate a system for using this same method in unrelated donors and recipients.

The Food and Drug Administration has approved G-CSF for several uses, including collection of blood stem cells from patients who are receiving transplants of their own stem cells; for patients with cancer who are receiving chemotherapy; patients who are getting bone marrow transplants; and patients with diseases that cause very low white blood cells counts.

Individuals matched by the National Marrow Donor Program with a potential recipient for blood stem cell donation are eligible for this study. Participants will receive oral and written information about all the procedures involved in both bone marrow and peripheral blood stem cell collection, from donor evaluation and testing through post-donation followup. They will then have a medical examination, including blood tests and urinalysis, electrocardiogram and chest X-ray, to make sure that neither the donor nor the recipient will incur unexpected risks from the procedure. If the evaluation confirms that the donation can proceed, the donor will receive G-CSF injections under the skin once a day for 4 or 5 days. Blood samples (1/2 to 1 tablespoon each) will be collected on the first and fourth days of G-CSF injections to measure blood cell counts.

Stem cells will then be collected by a procedure called apheresis. The donor lies in a recliner chair, and a needle is placed in a vein in each arm. Blood is collected from one arm and passes through a special machine called a blood cell separator. The machine collects the stem cells in a bag and directs the rest of the blood back through the needle in the other arm. One or two donations will be needed, depending on the size of the recipient and the number of stem cells circulating in the donor's bloodstream. Each donation takes about 4 to 5 hours. One-half tablespoon of blood is drawn before and after each donation to measure blood cell counts.

Two days after donation and again one week after donation, donors will be questioned about any symptoms the may experience. Another blood sample (1/2 tablespoon) will be collected 1 month after cell donation and then yearly for an indefinite number of years to measure cell counts.

Sponsoring Institute:
Warren G. Magnuson Clinical Center (CC)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility 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:

Failure to qualify as an NMDP marrow donor.

Pregnancy or uninterruptible breast-feeding. Pregnancy is an absolute contraindication under this protocol. Women who are breast-feeding must be willing and able to interrupt breast-feeding 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 autoimmune thyroid disease who have undergone medical or surgical thyroid ablation may be eligible. Approval must be obtained from the NMDP.

History of deep vein thrombosis or pulmonary embolism. History of iritis or episcleritis. Thrombocytopenia less than 150 x 10(9)/L (less than 150,000/microliter) 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.

History of coronary artery disease. History of chest pain consistent with angina shall be evaluated by cardiology consultation, and subjects with symptomatic coronary heart disease shall be excluded.

Special Instructions: Currently Not Provided
Keywords:
Unrelated Donor
Peripheral Blood Stem Cells
Hematopoietic Stem Cell Transplantation
Filgrastim
Recruitment Keywords:
Bone Marrow Donation
Conditions:
Hematopoietic Stem Cell Mobilization
Investigational Drug(s):
Filgrastim
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Syngeneic transplantation with peripheral blood mononuclear cells collected after the administration of recombinant human granulocyte colony-stimulating factor

Allogeneic blood stem cell transplantation: peripheralization and yield of donor-derived primitive hematopoietic progenitor cells (CD34+ Thy-1dim) and lymphoid subsets, and possible predictors of engraftment and fraft-versus-h

Allogeneic blood stem cell transplantation for refractory leukemia and lymphoma: potential advantage of blood over marrow allografts

Active Accrual, Protocols Recruiting New Patients

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