Status:
TERMINATED
Lenalidomide, Vorinostat and Dexamethasone in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)
Lead Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Celgene Corporation
Conditions:
Peripheral T-Cell Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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. ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00972842
Start Date
September 1 2009
End Date
July 1 2012
Last Update
December 24 2013
Active Locations (5)
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1
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
Innsbruck, Tyrol, Austria, A-6020
2
Krankenhaus der Elisabethinen Linz
Linz, Austria, A-4010
3
Krankenhaus der Stadt Linz
Linz, Austria, A-4020
4
Universitaetsklinik f. Innere Medizin III
Salzburg, Austria, A-5020