Lenalidomide, Vorinostat and Dexamethasone in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL) (LenVoDex)
This study is currently recruiting participants.
Verified March 2012 by Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators:
Merck
Celgene Corporation
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00972842
First received: September 7, 2009
Last updated: March 16, 2012
Last verified: March 2012
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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:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Vorinostat
Lenalidomide
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Vorinostat, Lenalidomide
- Revlimid®
- Zolinza®
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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972842
Contacts
| Contact: Daniela Wolkersdorfer, PhD | +43 664 1422504 | d.wolkersdorfer@agmt.at |
Locations
| Austria | |
| Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie | Not yet recruiting |
| Innsbruck, Tirol, Austria, A-6020 | |
| Contact: Wolfgang Willenbacher | |
| Principal Investigator: Wolfgang Willenbacher | |
| Krankenhaus der Elisabethinen Linz | Not yet recruiting |
| Linz, Austria, A-4010 | |
| Contact: Michael Girschikowsky, OA.Dr. | |
| Principal Investigator: Michael Girschikowsky | |
| Krankenhaus der Stadt Linz | Not yet recruiting |
| Linz, Austria, A-4020 | |
| Contact: Michael Fridrik, Dr. +437327806 ext 1610 michael.fridrik@akh.linz.at | |
| Principal Investigator: Michael Fridrik, Doz.Dr. | |
| Universitaetsklinik f. Innere Medizin III | Not yet recruiting |
| Salzburg, Austria, A-5020 | |
| Contact: Richard Greil, Prof. Dr. +43 662 4482 ext 2879 r.greil@salk.at | |
| Principal Investigator: Richard Greil, Prof.Dr. | |
| Hanusch Krankenhaus | Recruiting |
| Vienna, Austria, A-1140 | |
| Contact: Georg Hopfinger, Dr | |
| Principal Investigator: Georg Hopfinger | |
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Merck
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: | March 16, 2012 |
| 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 June 17, 2013