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Clinical Trials/EUCTR2008-006919-20-AT
EUCTR2008-006919-20-AT
Active, not recruiting
Not Applicable

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) - LenVoDex

Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH0 sitesJuly 27, 2009
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DrugsRevlimidZolinzaDexamethason Nycomed

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 27, 2009
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients with relapsed PTCL according to WHO criteria who have received max. two previous treatments for PTCL or patients with primary refractory PTCL after one previus treatment
  • •Age \= 18 years.
  • •Adequate bone marrow function
  • •Alkaline phosphatase and transaminases \= 2,5 x ULN
  • •Total bilirubin \= 2,5 x ULN
  • •Creatinine clearance \= 50 ml/min
  • •Life expectancy \> 6 months
  • •ECOG performance status 0\-2
  • •CIRS score \= 6
  • •Ability and willingness to adhere to antithrombotic prophylaxis

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
  • •Pregnant or lactating women
  • •Any of the following concomitant conditions: clinically manifest heart failure NYHA stages III and IV, myocardial infarction within the last six months, chronic lung disease with severe hypoxemia, severe diabetes mellitus that cannot be stabilized, severe arterial hypertension that cannot be stabilized
  • •Known history of Deep Vein Thrombosis and/ or pulmonary embolism
  • •Active infection or severe infection (WHO 4th degree) within the last three months before inclusion in the study, seropositivity for HIV, HBV or HCV

Outcomes

Primary Outcomes

Not specified

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