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

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

This study is currently recruiting participants.

Verified by Arbeitsgemeinschaft medikamentoese Tumortherapie, March 2010

First Received: September 7, 2009 Last Updated: March 2, 2010 History of Changes

Sponsor:	Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators:	Merck Celgene Corporation
Information provided by:	Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:	NCT00972842

Purpose

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.

Condition	Intervention	Phase
Peripheral T-Cell Non-Hodgkin's Lymphoma	Drug: Vorinostat, Lenalidomide	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Suberoylanilide hydroxamic acid Lenalidomide CC 5013 Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972842

Contacts

Contact: Daniela Wolkersdorfer, PhD

+43 664 1422504

d.wolkersdorfer@agmt.at

Locations

Austria
Krankenhaus der Elisabethinen Linz	Not yet recruiting
Linz, Austria, A-4010
Contact: Michael Girschikowsky, OA.Dr.
Principal Investigator: Michael Girschikowsky
Krankenhaus der Stadt Linz	Not yet recruiting
Linz, Austria, A-4020
Contact: Michael Fridrik, Dr. +437327806 ext 1610 michael.fridrik@akh.linz.at
Principal Investigator: Michael Fridrik, Doz.Dr.
Universitaetsklinik f. Innere Medizin III	Not yet recruiting
Salzburg, Austria, A-5020
Contact: Richard Greil, Prof. Dr. +43 662 4482 ext 2879 r.greil@salk.at
Principal Investigator: Richard Greil, Prof.Dr.
Hanusch Krankenhaus	Recruiting
Vienna, Austria, A-1140
Contact: Georg Hopfinger, Dr
Principal Investigator: Georg Hopfinger
Austria, Tirol
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie	Not yet recruiting
Innsbruck, Tirol, Austria, A-6020
Contact: Wolfgang Willenbacher
Principal Investigator: Wolfgang Willenbacher

Sponsors and Collaborators

Arbeitsgemeinschaft medikamentoese Tumortherapie

Merck

Celgene Corporation

Investigators

Principal Investigator:

Georg Hopfinger, MD

Hanusch Krankenhaus Wien

More Information

No publications provided

Responsible Party:	AGMT ( Univ.-Prof Dr. Richard Greil )
Study ID Numbers:	AGMT_PTCL1, EudraCT 2008-006919-20
Study First Received:	September 7, 2009
Last Updated:	March 2, 2010
ClinicalTrials.gov Identifier:	NCT00972842 History of Changes
Health Authority:	Austria: Federal Office for Safety in Health Care

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

PTCL
Peripheral T-Cell Non-Hodgkin's Lymphoma
Vorinostat
Lenalidomid

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Dexamethasone
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Sensory System Agents
Lymphoma, T-Cell
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Lymphoma

Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Vorinostat
Lenalidomide
Gastrointestinal Agents
Enzyme Inhibitors
Protective Agents
Glucocorticoids
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Analgesics, Non-Narcotic
Autonomic Agents

ClinicalTrials.gov processed this record on March 18, 2010