Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies
Summary
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine, when given before an allogeneic (bone marrow , blood, or cord blood cells) or haploidentical (bone marrow) stem cell transplantation can help to control cancers of the bone marrow and lymph node system. The safety of this treatment will also be studied. This is an investigational study. Thiotepa and clofarabine are FDA approved and commercially available for the treatment of leukemia. Busulfan is FDA approved and commercially available for use in stem cell transplantation. The combination of thiotepa, clofarabine, and busulfan together with a stem cell transplant is investigational. Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
Timeline
- Start
- 2009-03-02
- Primary completion
- 2019-03-09
- Completion
- 2019-03-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 0.5 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 5000 unknown | Intravenous |
| Subject | Clofarabine | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Thiotepa | Other / unclassified | 5 mg/kg | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 10 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Background | Methotrexate | Small molecule | 5 mg/m2 | Intravenous |
| Background | Tacrolimus | Small molecule | 0.015 mg/kg | Intravenous |
| Background | Thymoglobulin | Protein / enzyme biologic | 1.75 mg/kg | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |