drugset / Trial / NCT01746849
Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation
Phase 2
Active not recruiting
82 enrolled
Memorial Sloan Kettering Cancer Center
Swedish Orphan Biovitrum · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to help determine if palifermin and leuprolide acetate can help the immune system recover faster following a stem cell transplant. Blood stem cells are very young blood cells that grow in the body to become red or white blood cells or platelets. The transplant uses stem cells in the blood from another person. The donor can be a family member or a volunteer donor. This is called an allogeneic stem cell transplant. The investigators want to see if palifermin and leuprolide acetate can help the immune system recover faster after an allogenic transplant because experiments have shown they may be able to do this.
Timeline
- Start
- 2012-12
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Degarelix | Other / unclassified | 240 ug | Subcutaneous |
| Subject | Leuprolide | Other / unclassified | — | — |
| Subject | Palifermin | Protein / enzyme biologic | 60 ug/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Thiotepa | Other / unclassified | 5 mg/kg | Intravenous |