A Randomized Phase III Study to Evaluate the Efficacy of Chemoimmunotherapy With the Monoclonal Antibody Campath-1H (Alemtuzumab) Given in Combination With 2-weekly CHOP Versus 2-weekly CHOP Alone and Consolidated by Autologous Stem Cell Transplant, in Young Patients With Previously Untreated Systemic Peripheral T-cell Lymphomas
First International phase III T-cell lymphoma study Indication:Newly diagnosed non-cutaneous
peripheral T-cell lymphoma Study objectives:Determination of the efficacy and safety of the
monoclonal antibody MabCampath® (alemtuzumab) combined with two-weekly CHOP supported by
G-CSF Primary Endpoint: Event-Free-Survival (EFS) Study Design: International open-label,
multicentre, randomized Phase III Study
Study Medication: Patients are randomized to six cycles of two-weekly CHOP plus G-CSF with
or without alemtuzumab given subcutaneously 30 mg day 1 in combination with chemotherapy
cycles 1-4. Patients in CR, CRu and PR after the 6 cycles of CHOP14 combined or not with
alemtuzumab will receive a consolidation with high-dose chemotherapy followed by autologous
stem cell transplantation.
Patient Population: Patients > 18 yrs with newly diagnosed non-cutaneous, non-leukemic PTCL,
except alk-protein positive and negative anaplastic large cell lymphoma Planned Sample Size:
308 young patients (18-60 yrs) registered and randomized Total Number of Centers: This study
will be proposed to main European and Australian Study Groups.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Event-free Survival
The EFS is defined by the time between day of randomization until an event occurs, up to 96 months
No
Francesco d'Amore, Prof
Principal Investigator
Dept. of Hematology, Århus University Hospital, Denmark
Denmark: Danish Medicines Agency
2006-006130-17
NCT00646854
June 2008
December 2016
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