Phase I/II Trial of Lenalidomide in Combination with Vorinostat and Dexamethasone as Therapy in Relapsed or Refractory Patients with Peripheral T-Cell Non-Hodgkin’s Lymphoma (PTCL)

Conditions: Peripheral T-Cell Non-Hodgkin’s Lymphoma (PTCL)
MedDRA version: 13.1Level: HLTClassification code 10034622Term: Peripheral T-cell lymphomas NECSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2008-006919-20-AT

Lead Sponsor: Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

•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