Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis
Summary
The goal of this clinical research study is to compare the effect of adding either alemtuzumab or tocilizumab to the drug combination of etoposide and dexamethasone in controlling HLH. The safety of the drug combinations will also be studied. This is an investigational study. Alemtuzumab, etoposide, tocilizumab, and dexamethasone are not FDA approved for the treatment of HLH. Etoposide is FDA approved and commercially available for the treatment of testicular cancer and lung cancer. Alemtuzumab is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia. Dexamethasone is a steroid used to reduce inflammation. Tocilizumab is FDA approved and commercially available for the treatment of arthritis. The combination of alemtuzumab, etoposide, tocilizumab, and dexamethasone to treat HLH is investigational. The study doctor can explain how the drugs are designed to work. Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
Timeline
- Start
- 2015-09-23
- Primary completion
- 2023-01-24
- Completion
- 2023-01-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | 0.2 mg/kg | Subcutaneous |
| Subject | Dexamethasone | Small molecule | 1.25 mg/m2 | Intravenous |
| Subject | Induction Phase: 150 mg/m2 given by vein once a week for 8 weeks. Maintenance Phase: Participants who have evidence of refractory disease or budding relapse du | Unknown | 150 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 12 mg | Intrathecal |
| Subject | Tocilizumab | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |