Romidepsin Maintenance After Allogeneic Stem Cell Transplantation
Summary
The goal of this clinical research study is to learn if giving romidepsin before and after a stem cell transplant in combination with fludarabine and busulfan can help to control leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin that can be given with this combination. The safety of this combination and the safety of giving romidepsin after a stem cell transplant will also be studied. This is an investigational study. Romidepsin is FDA approved and commercially available for the treatment of CTCL in patients who have received at least 1 systemic (affecting the whole body) therapy before. Busulfan and fludarabine are FDA approved and commercially available for use with a stem cell transplant. The use of the combination of romidepsin, busulfan, and fludarabine to treat the type of leukemia or lymphoma you have is considered investigational. Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
Timeline
- Start
- 2017-12-08
- Primary completion
- 2023-10-06
- Completion
- 2025-06-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 1 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 2 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 3 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 8 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 40 mg/m2 | Intravenous |
| Background | Thymoglobulin | Protein / enzyme biologic | — | Intravenous |