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

This study has been terminated.
(slow recruitment)
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Celgene Corporation
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00972842
First received: September 7, 2009
Last updated: December 23, 2013
Last verified: December 2013

September 7, 2009
December 23, 2013
September 2009
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00972842 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Lenalidomide, Vorinostat and Dexamethasone in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)
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)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral T-Cell Non-Hodgkin's Lymphoma
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®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
July 2012
July 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00972842
AGMT_PTCL1, EudraCT 2008-006919-20
No
Arbeitsgemeinschaft medikamentoese Tumortherapie
Arbeitsgemeinschaft medikamentoese Tumortherapie
  • Merck Sharp & Dohme Corp.
  • Celgene Corporation
Principal Investigator: Georg Hopfinger, MD Hanusch Krankenhaus Wien
Arbeitsgemeinschaft medikamentoese Tumortherapie
December 2013

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