Alemtuzumab and CHOP in T-cell Lymphoma
- Conditions
- Lymphoma, T-Cell, Peripheral
- Interventions
- Drug: CHOP14 chemotherapy (see specification under Arm B) plus G-CSFDrug: CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab
- Registration Number
- NCT00646854
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
Not provided
- Patients with NK/T-NHL of the following type:
- Precursor T cell lymphoblastic lymphoma/leukemia
- All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL, HTLV1-pos ATL)
- Alk-positive and negative anaplastic large cell lymphoma
- Blastic NK cell lymphoma
- Cutaneous T-cell lymphoma, transformed or not
- Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection), which could compromise participation in the study.
- Known hypersensitivity to murine or chimeric antibodies or proteins
- Severe cardiac dysfunction (NYHA classification II-IV, Appendix H) or LVEF < 45 %
- Significant renal dysfunction, i.e. serum creatinin >2 times upper normal level (UNL), unless related to NHL
- Significant hepatic dysfunction (total bilirubin >2 times UNL or transaminases >= 2.5 times UNL), unless related to NHL
- Impaired pulmonary functions; in this case, the patient is to be excluded if the resultant pulmonary function test shows FEV1<50% or a diffusion capacity <50% of the reference values
- Suspected or documented Central Nervous System involvement by NHL
- Patients known to be HIV-positive
- Patients with active, uncontrolled infections, especially known seropositivity for HCV or HbsAg
- Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
- Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of extranodal NK/T cell lymphoma, nasal or nasal type
- History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
- Unwillingness or inability to comply with the protocol
- Simultaneous participation in any other study protocol
- Pregnant and nursing women (Women of childbearing potential should use safe anticonceptives) Contraceptive pills, intrauterine devices, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices and transdermal patches are considered as safe contraceptive methods).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A CHOP14 chemotherapy (see specification under Arm B) plus G-CSF - Arm B CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab -
- Primary Outcome Measures
Name Time Method Event-free Survival The EFS is defined by the time between day of randomization until an event occurs, up to 96 months
- Secondary Outcome Measures
Name Time Method Overall survival From the time of randomisation to date of last follow-up or death, up to 96 months Overall response rate from date of randomization to date of primary response assessment, up to 96 months Tumor control or time-to-progression time of randomization to last follow-up or time of disease progression, up to 96 months Overall response rate related to the CD52 expression From date of randomization to date of primary response assessment, up to 96 months Safety measured as number of adverse events (AEs) and serious adverse events (SAEs) from randomization to closure of study, up to 96 months Feasibility of successful stem cell harvest i.e. >/=2E6 CD34 positive cells from start of priming regimen to time of assessment of stem cell harvest, up to 96 months
Trial Locations
- Locations (59)
University Hospital Kralovske Vinohrady
🇨🇿Prague, Czechia
University Hospital Brno
🇨🇿Brno, Czechia
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Center for Clinical Cancer and Immunology Trials
🇦🇹Salzburg, Austria
Lund University Hospital
🇸🇪Lund, Sweden
University Hospital Motol
🇨🇿Prague, Czechia
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Charite Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Sunderby Hospital
🇸🇪Lulea, Sweden
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Erasmus Medical Center - Centrum
🇳🇱Rotterdam, Netherlands
University Hospital Regensburg
🇩🇪Regensburg, Germany
Krankenhaus Nordwest
🇩🇪Frankfurt, Germany
Norrlands University Hospital
🇸🇪Umea, Sweden
Aalborg Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Herlev Hospital
🇩🇰Herlev, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Vejle Hospital
🇩🇰Vejle, Denmark
CHR de la Citadelle
🇧🇪Liége, Belgium
University Hospital Ostrava
🇨🇿Ostrava, Czechia
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
UZ VUB
🇧🇪Brussels, Belgium
AKH Linz
🇦🇹Linz, Austria
Oulu University Hospital
🇫🇮Oulu, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Hanusch Krankenhaus
🇦🇹Vienna, Austria
ZNA Stuivenberg
🇧🇪Antwerpen, Belgium
ZNA Middelheim
🇧🇪Antwerpen, Belgium
Clinique St Pierre
🇧🇪Ottignies, Belgium
Heilig-Hartziekenhuis
🇧🇪Roeselare, Belgium
Krankenhaus der Elisabethinen
🇦🇹Linz, Austria
Hôpital de Jolimont
🇧🇪Haine-St-Paul, Belgium
AZ St Jan
🇧🇪Brugge, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Isala Klinieken, Sophia
🇳🇱Zwolle, Netherlands
Radium Hospital
🇳🇴Oslo, Norway
St. Olavs Hospital
🇳🇴Trondheim, Norway
Grand Hôpital de Charleroi
🇧🇪Charleroi, Belgium
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Clinique de Mont-Godinne
🇧🇪Yvoir, Belgium
Kuopio University Hospital
🇫🇮Kuopio, Finland
Turku University Central Hospital
🇫🇮Turku, Finland
Meander Medical Center
🇳🇱Amersfoort, Netherlands
Vrije University Medical Center
🇳🇱Amsterdam, Netherlands
Haga Ziekenhuis, loc. Leyenburg
🇳🇱Den Haag, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Stavanger University Hospital
🇳🇴Stavanger, Norway
University Hospital of Nothern Norway
🇳🇴Tromsoe, Norway
IPO Lisboa
🇵🇹Lisbon, Portugal
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
University Medical Center St. Radboud
🇳🇱Nijmegen, Netherlands
Leids University Medical Center
🇳🇱Leiden, Netherlands
Sint Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Erasmus Medical Center Daniel
🇳🇱Rotterdam, Netherlands
Marie Sklodowska-Curie Memorial Institute Cancer Center
🇵🇱Warsaw, Poland
IPO Porto
🇵🇹Porto, Portugal