Lenalidomide, Vorinostat and Dexamethasone in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)

Study Overview
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Brief Summary
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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.

Official Title
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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
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Peripheral T-Cell Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Vorinostat, Lenalidomide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vorinostat, Lenalidomide|Lenalidomide: Dose escalation 10 /15 /20 /25mg/d d1-21 q28d; for 6 treatment cycles Vorinostat: 400 mg d1-21 q28d, for 6 treatment cycles|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTCL, Peripheral T-Cell Non-Hodgkin's Lymphoma, Vorinostat, Lenalidomid