The Effectiveness of Alemtuzumab Given in Combination With CHOP and ESHAP in Patients Newly Diagnosed With Peripheral T-Cell Lymphoma (PTCL) (C+CHOP/ESHAP)
- 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?
- Secondary Research Question What is the incidence of life-threatening toxicities (grade 3 and 4, according to WHO criteria, Appendix A) in the patients?
|Peripheral T-cell Lymphoma||Drug: CHOP regimen alternate with ESHAP regimen Drug: Alemtuzumab||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Alemtuzumab in Combination With CHOP and ESHAP as First-Line Treatment in Peripheral T-Cell Lymphoma|
- The response to treatment and the treatment-related toxicity. [ Time Frame: 3 years ]
|Study Start Date:||January 2005|
|Study Completion Date:||July 2008|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Experimental: Alemtuzumab combination with CHOP and ESHAP
Alemtuzumab 30 mg/day is given subcutaneously on day 1-3 of cycle 1-5. CHOP alternate with ESHAP is given every 21 days for a total of 6 course.
Drug: CHOP regimen alternate with ESHAP regimen
CHOP alternate with ESHAP is given every 21 days for a total of 6 course.Drug: Alemtuzumab
Alemtuzumab 30 mg/day is given subcutaneously on day 1-3 of cycle 1-5.
Alemtuzumab (Campath-1H) is a humanized monoclonal antibody that targets CD52, a cell surface protein present at high density on most normal and malignant B and T lymphocytes.
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) is currently regarded as a standard chemotherapy regimen for patients with newly diagnosed NHL.
ESHAP (etoposide, methylprednisolone, cisplatin, cytosine arabinoside) chemotherapy was invented in 1994. The regimen was aimed to salvage NHL patients who were relapsing or refractory to front-line, mostly doxorubicin-based, chemotherapy.Major toxicities were myelosuppression; 30% of the patients developed febrile neutropenia and was admitted for parenteral antibiotics. Treatment-related deaths, mostly from uncontrolled sepsis, occurred in 4% of the patients. Because of its efficacy and tolerable toxicities, at present, ESHAP is one of the salvage chemotherapy regimens most frequently administered to patients especially prior to autologous stem cell transplantation.
Recently, our unit had reported the efficacy of the combination of standard CHOP chemotherapy and ESHAP and high-dose therapy with autologous stem cell transplantation or rituximab given as upfront therapy in patients newly diagnosed as poor prognosis aggressive NHL (high- and high-intermediate risk groups according to the international index).15,16 According to the previous institutional experience as well as the efficacy of the combination of CHOP and ESHAP in patients with high-risk aggressive lymphoma, we would like therefore to determine the outcome of alemtuzumab given in combination with CHOP and ESHAP in patients newly diagnosed with PTCL, the effectiveness of which has not been known.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930605
|King Chulalongkorn Memorial Hospital|
|Principal Investigator:||Tanin Intragumtornchai, M.D.||Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University|