Patients >18 years with relapsed or resitant peripheral T-cell lymphoma, defined as having progressed on 1st or 2nd line therapy. MedDRA version: 9.1 Level: LLT Classification code 10042973 Term: T-cell lymphoma NOS recurrent MedDRA version: 9.1 Level: LLT Classification code 10042974 Term: T-cell lymphoma NOS refractory MedDRA version: 9.1 Level: LLT Classification code 10042979 Term: T-cell lymphoma recurrent MedDRA version: 9.1 Level: LLT Classification code 10042980 Term: T-cell lymphoma
Conditions
Interventions
Trade Name: Nexavar
Pharmaceutical Form: Film-coated tablet
Sponsors
Region Skåne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Relapsed or resistant disease (progression on 1st or 2nd line therapy) Confirmed histopatological diagnosis of peripheral T-cell NHL according to WHO classification > 18 years ECOG performance status 0-2 Life expectancy at least 12 weeks At least 1 lymph node or nodal mass >1.5 cm Adequate bone marrow, liver and renal function Signed 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of cardiac disease History of HIV infection or cronic hepatitis B or C Active clinically serious infections Symptomatic metastatic brain or meningeal tumors Seizure disorders requiring medication History of organ allograft Evidence or history of bleeding diasthesis Renal dialysis Previoius or concurrent cancer, except cervical carcinoma in situ, treated basal squamaos cell skin carcinoma, superficial bladder tomours or any cancer curatively treated >3 years Patients eligable for curative therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assesse the effect of Nexavar measured as progression-free-survival ;Secondary Objective: To assess the effect of Nexavar measured as overall-response-rate, clinical benefit rate, duration of response rate of subjects being progression free at 3, 6 and 12 months. Assess the safety of Nexavar, measured by adverse events, laboratory findings, vital signs and rate of serious infections. Analyses of biomarker expressions at screening, 3 months, end of treatment and end of study. ;Primary end point(s): Progression-free-survival, defined as the time from study medication until progressive disease or death as a result of any cause. | — |
Countries
Sweden
Outcome results
None listed