Clinical trial NCT00972842: Lenalidomide, Vorinostat and Dexamethasone in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)
Official 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Peripheral T-Cell Non-Hodgkin's Lymphoma
Keywords: PTCL
Peripheral T-Cell Non-Hodgkin's Lymphoma
Vorinostat
Lenalidomid
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Celgene Corporation
First posted: 2009-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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)
timeFrame: 6 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
state: Tirol
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz
city: Linz
country: Austria
facility: Krankenhaus der Stadt Linz
city: Salzburg
country: Austria
facility: Universitaetsklinik f. Innere Medizin III
city: Vienna
country: Austria
facility: Hanusch Krankenhaus
Study officials:
affiliation: Hanusch Krankenhaus Wien
name: Georg Hopfinger, MD
role: PRINCIPAL_INVESTIGATOR
References: