Peripheral T-Cell Non-Hodgkin’s Lymphoma (PTCL) MedDRA version: 13.1 Level: HLT Classification code 10034622 Term: Peripheral T-cell lymphomas NEC System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Revlimid
Product Name: Revlimide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with relapsed PTCL according to WHO criteria who have received max. two previous treatments for PTCL or patients with primary refractory PTCL after one previus treatment • Age = 18 years. • Adequate bone marrow function • Alkaline phosphatase and transaminases = 2,5 x ULN • Total bilirubin = 2,5 x ULN • Creatinine clearance = 50 ml/min • Life expectancy > 6 months • ECOG performance status 0-2 • CIRS score = 6 • Ability and willingness to adhere to antithrombotic prophylaxis Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Prior history of malignancies, other than PTCL, unless the subject has been free of the disease for = 3 years • Prior allogeneic bone marrow transplant or plans to undergo autologous/ allogeneic bone marrow transplant within 4 weeks of the initiation of vorinostat administration • Pregnant or lactating women • Any of the following concomitant conditions: clinically manifest heart failure NYHA stages III and IV, myocardial infarction within the last six months, chronic lung disease with severe hypoxemia, severe diabetes mellitus that cannot be stabilized, severe arterial hypertension that cannot be stabilized • Known history of Deep Vein Thrombosis and/ or pulmonary embolism • Active infection or severe infection (WHO 4th degree) within the last three months before inclusion in the study, seropositivity for HIV, HBV or HCV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determine the maximum tolerated dose (MTD) of a Lenalidomide, Vorinostat, and Dexamethasone combination regimen ;Secondary Objective: • To determine the remission rate • To determine the median progression-free survival times • To determine the median overall survival time • To determine the safety of this regimen ;Primary end point(s): The primary objective of this study is to determine the maximum tolerated dose (MTD) of a Lenalidomide, Vorinostat, and Dexamethasone combination regimen in terms of occurrence of dose-limiting toxicities (DLT) at any dose level.;Timepoint(s) of evaluation of this end point: Every 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the safety of the combination regimen. To determine the remission rate of the combination regimen. To determine the median progression free survival ;Timepoint(s) of evaluation of this end point: Every 4 weeks | — |
Countries
Austria
Contacts
Public ContactClinical Trials Information
AGMT
Outcome results
None listed