Lenalidomide, Vorinostat and Dexamethasone in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)
Information source: Arbeitsgemeinschaft medikamentoese Tumortherapie
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peripheral T-Cell Non-Hodgkin's Lymphoma
Intervention: Vorinostat, Lenalidomide (Drug)
Phase: Phase 1/Phase 2
Status: Not yet recruiting
Sponsored by: Arbeitsgemeinschaft medikamentoese Tumortherapie Official(s) and/or principal investigator(s):
Georg Hopfinger, MD, Principal Investigator, Affiliation: Hanusch Krankenhaus Wien
Overall contact:
Daniela Wolkersdorfer, PhD, Phone: +43 664 1422504, Email: d.wolkersdorfer@agmt.at
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.
Clinical Details
Official title: Phase I/II Trial of Lenalidomide in Combination With Vorinostat and Dexamethasone as Therapy in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: 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.
Secondary outcome: 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)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Daniela Wolkersdorfer, PhD, Phone: +43 664 1422504, Email: d.wolkersdorfer@agmt.at
Hanusch Krankenhaus, Vienna A-1140, Austria
Krankenhaus der Elisabethinen Linz, Linz A-4010, Austria
Krankenhaus der Stadt Linz, Linz A-4020, Austria
Universitaetsklinik f. Innere Medizin III, Salzburg A-5020, Austria
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie, Innsbruck, Tirol A-6020, Austria
Additional Information
Starting date: September 2009
Ending date: June 2011
Last updated: September 8, 2009
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