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

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ClinicalTrials.gov Identifier: NCT00972842
Recruitment Status : Terminated (slow recruitment)
First Posted : September 9, 2009
Last Update Posted : December 24, 2013
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Celgene Corporation
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

Tracking Information
First Submitted Date  ICMJE September 7, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date December 24, 2013
Study Start Date  ICMJE September 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
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 ]
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
 (submitted: September 8, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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 Terminated
Estimated Enrollment  ICMJE
 (submitted: September 8, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972842
Other Study ID Numbers  ICMJE AGMT_PTCL1
EudraCT 2008-006919-20
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Sponsor  ICMJE Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators  ICMJE
  • Merck Sharp & Dohme Corp.
  • Celgene Corporation
Investigators  ICMJE
Principal Investigator: Georg Hopfinger, MD Hanusch Krankenhaus Wien
PRS Account Arbeitsgemeinschaft medikamentoese Tumortherapie
Verification Date December 2013

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