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

Primary Purpose

Peripheral T-Cell Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Vorinostat, Lenalidomide
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-Cell Non-Hodgkin's Lymphoma focused on measuring PTCL, Peripheral T-Cell Non-Hodgkin's Lymphoma, Vorinostat, Lenalidomid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
  • Krankenhaus der Elisabethinen Linz
  • Krankenhaus der Stadt Linz
  • Universitaetsklinik f. Innere Medizin III
  • Hanusch Krankenhaus

Outcomes

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.

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)

Full Information

First Posted
September 7, 2009
Last Updated
December 23, 2013
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Merck Sharp & Dohme LLC, Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00972842
Brief Title
Lenalidomide, Vorinostat and Dexamethasone in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)
Acronym
LenVoDex
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Merck Sharp & Dohme LLC, Celgene Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-Cell Non-Hodgkin's Lymphoma
Keywords
PTCL, Peripheral T-Cell Non-Hodgkin's Lymphoma, Vorinostat, Lenalidomid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vorinostat, Lenalidomide
Other Intervention Name(s)
Revlimid®, Zolinza®
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Hopfinger, MD
Organizational Affiliation
Hanusch Krankenhaus Wien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Krankenhaus der Stadt Linz
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Universitaetsklinik f. Innere Medizin III
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Hanusch Krankenhaus
City
Vienna
ZIP/Postal Code
A-1140
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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