Trial Information
Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event free survival
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Lorenz H Trümper, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Göttingen
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
DSHNHL 2006-1B / ACT-2
NCT ID:
NCT00725231
Start Date:
February 2008
Completion Date:
March 2014
Related Keywords:
- Peripheral T Cell Lymphoma, Unspecified
- Angioimmunoblastic Lymphadenopathy
- Extranodal NK/T-cell Lymphoma
- T cell lymphoma
- Immunoblastic Lymphadenopathy
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphatic Diseases