Patients 18 - 65 years old with newly diagnosed non-cutanous, non leukemic Peripheral T- cell lymphoma, except alk-protein positive and negative anaplastic large cell lymphoma. MedDRA version: 17.1 Level: PT Classification code 10042971 Term: T-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Mab Campath
Pharmaceutical Form: Solution for injection
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 9.1.1 Inclusion criteria - Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of stage I bulk (= 7.5 cm) and stages II to IV. - Patients with a confirmed histologic diagnosis of peripheral T-cell NHL according to the WHO classification (Appendix C): Peripheral T-cell lymphoma, unspecified (PTCL NOS), Angioimmunoblastic T-cell lymphoma, Enteropathy associated T cell lymphoma, Subcutaneous panniculitis-like T-NHL, Hepatosplenic gd T-cell lymphoma, Extranodal NK/T cell lymphoma, nasal type - Age 18-65 years at time or randomization - Life expectancy of 3 months or longer - WHO performance status (PS) 0, 1 or 2 at the time of randomization (see appendix D). However, PS 3 will be acceptable if lymphoma-related. - Measurable disease - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 288 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Patients with NK/T-NHL of the following types are excluded: Precursor T cell lymphoblastic lymphoma/leukemia, All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL), Alk-positive and negative anaplastic large cell lymphoma, Blastic NK cell lymphoma - Known hypersensitivity to murine or chimeric antibodies or proteins - Severe cardiac dysfunction (NYHA classification II-IV, Appendix H) or LVEF 2 times upper level), unless related to NHL - Significant hepatic dysfunction (total bilirubin ³ 30 mmol/l or transaminases ³ 2.5 times normal level), unless related to NHL - Impaired pulmonary functions; in this case, the patient is to be excluded if the resultant pulmoanry 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 steroid treatment - Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of extranodal NK/T cell lymphoma, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of the addition af Mab Campath s.c. to 2 Weekly CHOP 14 ( Chemotherapy) in terms of event free survival (EVS).;Secondary Objective: To assess the effect of the addition of alemtuzumab s.c. to 6 courses of 2-weekly CHOP14 in term of overall survival (OS), progression-free survival (PFS) and overall response rates (ORR, i.e. CR/CRu/PR). Assessment of ORR means evaluating eligibility to autologous stem cell transplantation. To evaluate the safety of the addition of alemtuzumab s.c. combined with 2-weekly CHOP with respect to the incidence of severe opportunistic infections and infections due to neutropenia as well as the adherence to protocol as defined in ;Primary end point(s): The primary endpoint is the Event-free Survival (EFS). The EFS is defined by the time between day of randomization until one of the following events occurs, whichever comes first: · Disease progression during therapy · Institution of any additional unplanned anti-tumor treatment · Relapse after achievement of CR/CRu · Death due to any cause Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Israel, Netherlands, Portugal, Sweden
Contacts
Public ContactACT-1 Clinical Trial Office
Dep. of Hematology, Aarhus University Hospital
Outcome results
None listed