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
  Purpose

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.


Condition Intervention Phase
Peripheral T-Cell Non-Hodgkin's Lymphoma
Drug: Vorinostat, Lenalidomide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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®
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972842

Locations
Austria
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
Innsbruck, Tirol, Austria, A-6020
Krankenhaus der Elisabethinen Linz
Linz, Austria, A-4010
Krankenhaus der Stadt Linz
Linz, Austria, A-4020
Universitaetsklinik f. Innere Medizin III
Salzburg, Austria, A-5020
Hanusch Krankenhaus
Vienna, Austria, A-1140
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Merck Sharp & Dohme Corp.
Celgene Corporation
Investigators
Principal Investigator: Georg Hopfinger, MD Hanusch Krankenhaus Wien
  More Information

No publications provided

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT00972842     History of Changes
Other Study ID Numbers: AGMT_PTCL1, EudraCT 2008-006919-20
Study First Received: September 7, 2009
Last Updated: December 23, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
PTCL
Peripheral T-Cell Non-Hodgkin's Lymphoma
Vorinostat
Lenalidomid

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Vorinostat
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014