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)

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00972842

Acronym

LenVoDex

Enrollment

Registered

2009-09-09

Start date

2009-09-30

Completion date

2012-07-31

Last updated

2013-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral T-Cell Non-Hodgkin's Lymphoma

Keywords

PTCL, Peripheral T-Cell Non-Hodgkin's Lymphoma, Vorinostat, Lenalidomid

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. 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.

Interventions

DRUGVorinostat, 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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.	6 months

Secondary

Measure	Time frame
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)	6 months

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026