Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is significantly worse than that of aggressive B cell lymphomas. The prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. Previous phase II trials have demonstrated a significant activity of the monoclonal anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense CHOP-14 in patients with previously untreated peripheral T cell lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Göttingen
• Collaborators: German High-Grade Non-Hodgkin's Lymphoma Study Group; Nordic Lymphoma Group
• Treatments: Alemtuzumab; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• all risk groups of peripheral T cell lymphoma

• performance status ECOG 0-2

• written consent

• measurable disease

Exclusion Criteria:

• stage I N without bulky disease

• already initiated treatment

• serious accompanying disorder or impaired organ function

• bone marrow involvement >25%

• HIV positivity

• leukemic manifestation of lymphoma

• simultaneous participation in another trial

• platelets < 100 000/ mm, leukocytes < 2500 /mm