Clinical trial NCT00655668: A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
Official title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®) in Subjects With Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: T-cell Non-Hodgkin's Lymphoma
Keywords: NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.

Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles). Subjects may continue participation in the Treatment Phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable adverse events develop.

All subjects who discontinue the Treatment Phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the Follow-up Phase.

Objectives:

Primary:

• To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival.

Secondary:

• To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL.

Detailed description: Study was terminated. Study data assessment revealed that study drug is active, but is not likely to be sufficiently active as a single agent in this population for registration purposes.

Eligibility criteria: Inclusion Criteria:

* Must understand and voluntarily sign an informed consent form.
* Must be ≥ 18 years of age at the time of signing the informed consent form.
* Must be able to adhere to the study visit schedule and other protocol requirements.
* Biopsy-proven T-cell Non-Hodgkin's Lymphoma, either:

  * Peripheral T-cell Lymphoma (PTCL) whatever the subtype, or
  * Cutaneous T-cell Lymphoma (CTCL), but only the subtype mycosis fungoides.
* Relapsed or refractory to previous therapy for T-cell Non-Hodgkin's Lymphoma.
* Must have received at least one prior combination chemotherapy regimen. There is no limit on the number of prior therapies.

Exclusion Criteria:

* Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.

Primary outcomes:
measure: Participants Categorized by Best Response as Determined by Investigator
timeFrame: Up to 24 months
Secondary outcomes:
measure: Duration of Response
timeFrame: Up to 24 months
measure: Time-to-Progression
timeFrame: Up to 24 months
measure: Progression-Free Survival
timeFrame: Up to 24 months
measure: Safety
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Garran
country: Australia
facility: The Canberra Hospital Building 3, L 2
state: Australian Capital Territory
city: Liverpool
country: Australia
facility: Cancer Therapy Centre
state: New South Wales
city: Cairns
country: Australia
facility: Clinical Research Unit Cairns Base Hospital
state: Queensland
city: Douglas
country: Australia
facility: The Townsville Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Ashford
country: Australia
facility: Ashford Cancer Centre
state: South Australia
city: North Terrace
country: Australia
facility: Royal Adelaide Hospital L3 East Wing
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital, 4th Floor, Clive Ward Centre
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincents Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Bruxelles
country: Belgium
facility: Institute Jules Bordet
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
city: Leuven
country: Belgium
facility: KUL
city: Ottignies
country: Belgium
facility: Clinique St Pierre
city: Yvoir
country: Belgium
facility: Cliniques universitaires UCL de Mont-Godinne
city: Nantes
country: France
facility: CHU Hôtel Dieu
state: Cedex 01
city: Tours
country: France
facility: Hôpital Bretonneau
state: Cédex 1
city: Angers
country: France
facility: CHU Hôpital Hôtel Dieu
state: Cédex 9
city: Place De Verdun Cedex
country: France
facility: Hôpital Claude Huriez
state: Lille
city: Cedex
country: France
facility: Hôpital Lapeyronie
state: Montpellier
city: Lyon Sud
country: France
facility: Centre Hospitalier Lyon Sud
state: Pierre-Bénite
city: Vandoeuvre Les Nancy
country: France
facility: CHRU Hôpitaux de Brabois - Hématologie
state: Rue Morvan Cedex
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Clermont-Ferrand
country: France
facility: Hôtel Dieu Pavillon Villemur Pasteur
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: Hopital Michallon
city: La Roche Sur Yon
country: France
facility: CHD Les Oudairies
city: Limoges
country: France
facility: CHU Dupuytren
city: Metz
country: France
facility: Hôpital N.D.de Bon Secours
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Hôpital de la Pitié Salpétriere
city: Rennes
country: France
facility: CHU Rennes Hôpital Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Cloud
country: France
facility: Centre René Huguenin
city: Toulouse
country: France
facility: Hôpital Purpan
city: Valence
country: France
facility: Centre Hospitalier
Study officials:
affiliation: Celgene Corporation
name: Kenichi Takeshita, MD
role: STUDY_DIRECTOR
References:
citation: Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. doi: 10.1016/j.ejca.2013.04.029. Epub 2013 May 31.