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

Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly

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.

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