drugset / Trial / NCT00453427
Alemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas
Phase 1/2
Completed
20 enrolled
Ontario Clinical Oncology Group (OCOG)
Genzyme, a Sanofi Company · collabSunnybrook Health Sciences Centre · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objectives of this study are to: 1. establish the safety and dose limiting toxicities of combining alemtuzumab with CHOP chemotherapy for patients with newly diagnosed aggressive T-cell lymphomas; and 2. to measure the pharmacokinetics of alemtuzumab used in different subcutaneous doses and schedules. This will then determine the dose with the highest achievable drug levels with acceptable toxicities worthy of further investigation. The secondary objectives are to: 1. establish the efficacy of combination alemtuzumab with CHOP chemotherapy; and 2. to measure the effects of combination alemtuzumab with CHOP chemotherapy on T-cell reconstitution and cytomegalovirus (CMV) reactivation.
Timeline
- Start
- 2006-09
- Primary completion
- 2013-06
- Completion
- 2015-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | — | Subcutaneous |