The purpose of this study is to determine efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
Cyclophosphamide 750 mg/m2 i.v. on day 1 Hydroxydaunorubicin 50 mg/m2 i.v. on day 1 Vincristin 1 mg/m2 i.v. day 1 (max. 2mg) Prednisone 50 mg/m2 p.o. day 1 to 5 Alemtuzumab 30 mg s.c.on day 1 of CHOP-14 cycles 1-4
6 cycles of CHOP every 2 weeks
Event-free Survival
Time frame: The EFS is defined by the time between day of randomization until an event occurs, up to 96 months
Overall survival
Time frame: From the time of randomisation to date of last follow-up or death, up to 96 months
Overall response rate
Time frame: from date of randomization to date of primary response assessment, up to 96 months
Overall response rate related to the CD52 expression
Time frame: From date of randomization to date of primary response assessment, up to 96 months
Tumor control or time-to-progression
Time frame: time of randomization to last follow-up or time of disease progression, up to 96 months
Safety measured as number of adverse events (AEs) and serious adverse events (SAEs)
Time frame: from randomization to closure of study, up to 96 months
Feasibility of successful stem cell harvest i.e. >/=2E6 CD34 positive cells
Time frame: from start of priming regimen to time of assessment of stem cell harvest, up to 96 months
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AKH Linz
Linz, Austria
Krankenhaus der Elisabethinen
Linz, Austria
Center for Clinical Cancer and Immunology Trials
Salzburg, Austria
Hanusch Krankenhaus
Vienna, Austria
ZNA Middelheim
Antwerp, Belgium
ZNA Stuivenberg
Antwerp, Belgium
AZ St Jan
Bruges, Belgium
UZ VUB
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Grand Hôpital de Charleroi
Charleroi, Belgium
...and 49 more locations