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

This study is currently recruiting participants.

Verified March 2012 by Arbeitsgemeinschaft medikamentoese Tumortherapie

Sponsor:

Collaborators:

Merck

Celgene Corporation

Information provided by (Responsible Party):

Arbeitsgemeinschaft medikamentoese Tumortherapie

ClinicalTrials.gov Identifier:

NCT00972842

First received: September 7, 2009

Last updated: March 16, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2009

Last Updated Date

March 16, 2012

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00972842 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Peripheral T-Cell Non-Hodgkin's Lymphoma

Intervention ^ICMJE

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

Other Names:

Revlimid®
Zolinza®

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2012

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Daniela Wolkersdorfer, PhD

+43 664 1422504

d.wolkersdorfer@agmt.at

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00972842

Other Study ID Numbers ^ICMJE

AGMT_PTCL1, EudraCT 2008-006919-20

Has Data Monitoring Committee

Responsible Party

Arbeitsgemeinschaft medikamentoese Tumortherapie

Study Sponsor ^ICMJE

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators ^ICMJE

Merck
Celgene Corporation

Investigators ^ICMJE

Principal Investigator:

Georg Hopfinger, MD

Hanusch Krankenhaus Wien

Information Provided By

Arbeitsgemeinschaft medikamentoese Tumortherapie

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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