Peripheral T-Cell Non-Hodgkin's Lymphoma Clinical Trial
— LenVoDexOfficial title:
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)
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.
| Status | Terminated |
| Enrollment | 20 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie | Innsbruck | Tirol |
| Austria | Krankenhaus der Elisabethinen Linz | Linz | |
| Austria | Krankenhaus der Stadt Linz | Linz | |
| Austria | Universitaetsklinik f. Innere Medizin III | Salzburg | |
| Austria | Hanusch Krankenhaus | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Arbeitsgemeinschaft medikamentoese Tumortherapie | Celgene Corporation, Merck Sharp & Dohme Corp. |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 6 months | Yes | |
| Secondary | Remission rate of a combination therapy with Lenalidomide, Vorinostat, and Dexamethasone in a treatment refractory or relapsed population, defined as the percentage of patients achieving a complete response (CR) or partial response (PR) | 6 months | No |