slow recruitment

A standard therapy is neither established in first-line patients nor in relapsed patients with PTCL, and there is still an unmet medical need to identify novel efficacious and safe therapy regimens.

The aim of this study is to evaluate the potential of a Lenalidomide plus Vorinostat and Dexamethasone combination therapy as an effective and safe therapeutic regimen, in the treatment of relapsed PTCL following failure of prior regimens.

Inclusion Criteria:

• Patients with relapsed PTCL according to WHO criteria who have received max. two previous treatments for PTCL
• Age ≥ 18 years.
• Adequate bone marrow function i.e. absolute neutrophile count of > 1000/µl and thrombocytes > 75,000/µl.
• Alkaline phosphatase and transaminases ≤ 2,5 x upper limit of normal (ULN)
• Total bilirubin ≤ 2,5 x ULN
• Creatinine clearance ≥ 50 ml/min
• Female subjects of childbearing potential† must: Understand that the study medication could have an expected teratogenic risk and agree to use, and be able to comply with, effective contraception and agree to have a medically supervised pregnancy test
• Male subjects must agree to use condoms and agree not to donate semen

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
• Prior treatment with a HDAC inhibitor
• Prior treatment with Lenalidomide (patients previously treated with Thalidomide may be enrolled)
• Known history of Deep Vein Thrombosis (DVT) and/ or pulmonary embolism (PE)