NCT00725231

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (estimated)
• Sponsor: University of Göttingen · Academic / Other
• Sex: All
• Age: 61 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral T Cell Lymphoma, Unspecified
• Angioimmunoblastic Lymphadenopathy
• Extranodal NK/T-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	alemtuzumab	Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles
DRUG	chemotherapy	dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF

Timeline

• Start date: 2008-02-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2008-07-30
• Last updated: 2012-05-07

Locations

1 site across 1 country: Germany