drugset / Trial / NCT00385788
Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
Non-randomizedSequentialOpen-labelTreatment
Summary
The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.
Timeline
- Start
- 2005-07
- Primary completion
- 2016-08
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Background | 0.03 mg/kg beginning Day -2 by vein over 24 hours; when tolerable change to pill form given once daily for 3-4 months. | Unknown | 0.03 mg/kg | — |
| Background | 5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD. | Unknown | 5 mg/m2 | — |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 2 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 33 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 70 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |