drugset / Trial / NCT00930605
The Effectiveness of Alemtuzumab Given in Combination With CHOP and ESHAP in Patients Newly Diagnosed With Peripheral T-Cell Lymphoma (PTCL)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
1. Primary Research Question What are the rates of complete response (CR), partial response (PR), progression free survival (PFS) and overall survival (OS) in adult patients newly diagnosed with Peripheral T-Cell Lymphoma (PTCL) who are treated with alemtuzumab given in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) and ESHAP (etoposide, methylprednisolone, cisplatin, cytosine arabinoside) administered as an up-front treatment? 2. Secondary Research Question What is the incidence of life-threatening toxicities (grade 3 and 4, according to WHO criteria, Appendix A) in the patients?
Timeline
- Start
- 2005-01
- Primary completion
- 2006-11
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Cytarabine | Small molecule | — | — |
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | Etoposide | Small molecule | — | — |
| Subject | Methylprednisolone | Other / unclassified | — | — |
| Subject | Prednisolone | Other / unclassified | — | — |
| Subject | Vincristine | Small molecule | — | — |