A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma (EXPECT)

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

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.

Study Overview

• Status: Terminated
• Conditions: T-cell Non-Hodgkin's Lymphoma
• Intervention / Treatment: Drug: Lenalidomide

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • The Canberra Hospital Building 3, L 2
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Cancer Therapy Centre
  • Queensland
    • Cairns, Queensland, Australia, 4870
      • Clinical Research Unit Cairns Base Hospital
    • Douglas, Queensland, Australia, 4814
      • The Townsville Hospital
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane & Women's Hospital
  • South Australia
    • Ashford, South Australia, Australia, 5035
      • Ashford Cancer Centre
    • North Terrace, South Australia, Australia, 5000
      • Royal Adelaide Hospital L3 East Wing
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital, 4th Floor, Clive Ward Centre
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • East Melbourne, Victoria, Australia, 3002
      • Peter MacCallum Cancer Centre
    • Fitzroy, Victoria, Australia, 3065
      • St Vincents Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St Luc
  • Bruxelles, Belgium, 1000
    • Institute Jules Bordet
  • Leuven, Belgium, 3000
    • KUL
  • Ottignies, Belgium, 1340
    • Clinique St Pierre
  • Yvoir, Belgium, 5530
    • Cliniques Universitaires UCL de Mont-Godinne
• France
  • Bordeaux, France, 33000
    • Polyclinique Bordeaux Nord Aquitaine
  • Clermont-Ferrand, France, 63000
    • Hôtel Dieu Pavillon Villemur Pasteur
  • Creteil, France, 94010
    • Hopital Henri Mondor
  • Dijon, France, 21000
    • CHU de DIJON
  • Grenoble, France, 38043
    • Hôpital Michallon
  • La Roche Sur Yon, France, 85000
    • CHD Les Oudairies
  • Limoges, France, 87042
    • Chu Dupuytren
  • Metz, France, 57000
    • Hôpital N.D.de Bon Secours
  • Paris, France, 75010
    • Hopital Saint-Louis
  • Paris, France, 75015
    • Hopital Necker
  • Paris, France, 75651
    • Hôpital de la Pitiê Salpêtriêre
  • Rennes, France, 35033
    • Chu Rennes Hopital Pontchaillou
  • Rouen, France, 76038
    • Centre Henri Becquerel
  • Saint Cloud, France, 92210
    • Centre Rene Huguenin
  • Toulouse, France, 31059
    • Hopital Purpan
  • Valence, France, 26953
    • Centre hospitalier
  • Cedex 01
    • Nantes, Cedex 01, France, 44093
      • Chu Hotel Dieu
  • Cédex 1
    • Tours, Cédex 1, France, 37044
      • Hopital Bretonneau
  • Cédex 9
    • Angers, Cédex 9, France, 49033
      • CHU Hôpital Hôtel Dieu
  • Lille
    • Place De Verdun Cedex, Lille, France, 59037
      • Hopital Claude Huriez
  • Montpellier
    • Cedex, Montpellier, France, 34295
      • Hopital Lapeyronie
  • Pierre-Bénite
    • Lyon Sud, Pierre-Bénite, France, 69495
      • Centre Hospitalier Lyon Sud
  • Rue Morvan Cedex
    • Vandoeuvre Les Nancy, Rue Morvan Cedex, France, 54511
      • CHRU Hôpitaux de Brabois - Hématologie
• United States
  • California
    • Beverly Hills, California, United States, 90211-1850
      • Tower Cancer Research Foundation
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lenalidomide; Open-label, oral lenalidomide monotherapy	Drug: Lenalidomide; Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle; Other Names: Revlimid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Categorized by Best Response as Determined by Investigator	Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail): Complete Response(CR): Complete disappearance of all detectable disease; Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow; Partial Response(PR): >50% decrease in six largest nodes/nodal masses; Stable Disease(SD): Less than PR, but not progressive disease; Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by >=50% in previous sites; Progressive Disease(PD): >=50% increase from low in PR/Non-Responders	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response	Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.	Up to 24 months
Time-to-Progression	Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.	Up to 24 months
Progression-Free Survival	Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.	Up to 24 months
Safety	Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)	Up to 24 months

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Kenichi Takeshita, MD, Celgene Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: April 4, 2008
• First Submitted That Met QC Criteria: April 9, 2008
• First Posted (Estimate): April 10, 2008

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide
• Other Study ID Numbers: CC-5013-TCL-001; 2007-002171-13 (EudraCT Number)