Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborator: National Marrow Donor Program
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

1. PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in the Donor Center Manual of Operations.

2. Confirmatory pregnancy test must be performed within 15 days of collection and prior to the start of filgrastim administration; this may require more than one test to be performed.

Exclusion Criteria:

1. 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.

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

3. 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.

4. History of deep vein thrombosis or pulmonary embolism.

5. History of iritis or episcleritis.

6. Thrombocytopenia < 150 x 10^9/L (< 150,000/uL) at baseline evaluation.

7. Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated.

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

9. Donors receiving experimental therapy or investigational agents.

10. Positive pregnancy test collected/reported prior to start of filgrastim.