Clinical Trial: Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly
Brief 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.
Detailed Summary:
Sponsor: University of Göttingen
Current Primary Outcome: Event free survival [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rate of complete and partial remissions [ Time Frame: 4 months after inclusion ]
- treatment related deaths [ Time Frame: time of occurence ]
- Overall survival [ Time Frame: @ 3 years ]
- protocol adherence [ Time Frame: 4 months of treatment ]
- immune reconstitution after alemtuzumab CHOP [ Time Frame: 3 years ]
Original Secondary Outcome:
- Rate of complete and partial remissions [ Time Frame: End of treatment ]
- treatment related deaths [ Time Frame: time of occurence ]
- Overall survival [ Time Frame: time of occurence ]
- protocol adherence [ Time Frame: treatment course ]
- immune reconstitution after alemtuzumab CHOP [ Time Frame: 3 years ]
Information By: University of Göttingen
Dates:
Date Received: July 25, 2008
Date Started: February 2008
Date Completion: March 2014
Last Updated: May 4, 2012
Last Verified: May 2012
