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

NCT ID: NCT00972842

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-07-31

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.

Detailed Description

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Conditions

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Peripheral T-Cell Non-Hodgkin's Lymphoma

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Revlimid® Zolinza®

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Celgene Corporation

INDUSTRY

Sponsor Role collaborator

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georg Hopfinger, MD

Role: PRINCIPAL_INVESTIGATOR

Hanusch Krankenhaus Wien

Locations

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Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie

Innsbruck, Tyrol, Austria

Site Status

Krankenhaus der Elisabethinen Linz

Linz, , Austria

Site Status

Krankenhaus der Stadt Linz

Linz, , Austria

Site Status

Universitaetsklinik f. Innere Medizin III

Salzburg, , Austria

Site Status

Hanusch Krankenhaus

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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EudraCT 2008-006919-20

Identifier Type: -

Identifier Source: secondary_id

AGMT_PTCL1

Identifier Type: -

Identifier Source: org_study_id