The Effectiveness of Alemtuzumab Combination With CHOP to Treat Patients Newly Diagnosed With PTCL

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the treatment of Alemtuzumab in combination with CHOP(cyclophosphamide,doxorubicin,vincristine and prednisolone) are effective as first line treatment in patients with peripheral T-cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Collaborator: Bayer
• Treatments: Alemtuzumab

Criteria

Inclusion Criteria:

• Patients must have a diagnosis of one of the following histologic types according to the WHO classification:

• Angioimmunoblastic T-cell lymphoma

• Extranodal NK/T-cell lymphoma,nasal type

• Enteropathy-type T-cell lymphoma

• Hepatosplenic gamma-delta T-cell lymphoma

• Subcutaneous panniculitis-like T-cell lymphoma

• Anaplastic large-cell lymphoma,T/null cell,primary systemic type

• Peripheral T-cell lymphoma,not otherwise characterized

• Newly diagnosed,age 15-65 years.

• Complete work up for baseline evaluation and measurement (Appendix B)

• Patient's free written inform consent.

Exclusion Criteria:

• Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab.

• Patients who have received prior antilymphoma treatment with chemotherapy or radiotherapy

• Patients with poor performance status (PS;ECOG criteria of 3-4)(Appendix C).

• Serologic evidence of HCV and HCV RNA of chronic hepatitis.

• Serologic evidence of HBV and HBV RNA of chronic hepatitis.

• Patients with history of impaired cardiac status or myocardial infarction.

• Patients with serum creatinine >= 1.8 mg/dl,bilirubin >= 1.5 times upper limit of normal range,SGOT or SGPT >= 3 times upper limit of normal range, unless due to tumor involvement.

• Patients with active uncontrolled infection,active non-malignant gastric or duodenal ulcer, uncontrolled diabetes mellitus or other severe medical conditions which would preclude aggressive cytotoxic chemotherapy.

• Active secondary malignancy.

• Pregnant or lactating women.

• Serious medical or psychiatric illness which prevent informed consent.

• Patients who are likely to lost to follow up (eg, unwilling or difficult to return,cannot be contacted).