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

Phase 2

Terminated

• Conditions: T-cell Non-Hodgkin's Lymphoma
• Interventions: Drug: Lenalidomide

• Registration Number: NCT00655668
• Lead Sponsor: Celgene

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.

Study Timeline

• Study Start: 2008-03-01
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-10
• Primary Completion: 2010-03-01
• Study Completion: 2010-04-01
• Results First Submitted: 2011-11-30
• Results First Submitted QC: 2011-11-30
• Results First Posted: 2012-01-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lenalidomide	Lenalidomide	Open-label, oral lenalidomide monotherapy

Primary Outcome Measures

Name	Time	Method
Participants Categorized by Best Response as Determined by Investigator	Up to 24 months	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

Secondary Outcome Measures

Name	Time	Method
Duration of Response	Up to 24 months	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.
Time-to-Progression	Up to 24 months	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.
Progression-Free Survival	Up to 24 months	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.
Safety	Up to 24 months	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.)

Trial Locations

Locations (45)

CHRU Hôpitaux de Brabois - Hématologie; 🇫🇷 Vandoeuvre Les Nancy, Rue Morvan Cedex, France

Hôpital Purpan; 🇫🇷 Toulouse, France

Institute Jules Bordet; 🇧🇪 Bruxelles, Belgium

Clinical Research Unit Cairns Base Hospital; 🇦🇺 Cairns, Queensland, Australia

The Townsville Hospital; 🇦🇺 Douglas, Queensland, Australia

Monash Medical Centre; 🇦🇺 Clayton, Victoria, Australia

The Canberra Hospital Building 3, L 2; 🇦🇺 Garran, Australian Capital Territory, Australia

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Cliniques Universitaires St Luc; 🇧🇪 Bruxelles, Belgium

Clinique St Pierre; 🇧🇪 Ottignies, Belgium

Cliniques universitaires UCL de Mont-Godinne; 🇧🇪 Yvoir, Belgium

Hôpital de la Pitié Salpétriere; 🇫🇷 Paris, France

CHU Hôpital Hôtel Dieu; 🇫🇷 Angers, Cédex 9, France

CHU Rennes Hôpital Pontchaillou; 🇫🇷 Rennes, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

Tower Cancer Research Foundation; 🇺🇸 Beverly Hills, California, United States

Western Pennsylvania Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Cancer Therapy Centre; 🇦🇺 Liverpool, New South Wales, Australia

Royal Brisbane & Women's Hospital; 🇦🇺 Herston, Queensland, Australia

Royal Adelaide Hospital L3 East Wing; 🇦🇺 North Terrace, South Australia, Australia

Ashford Cancer Centre; 🇦🇺 Ashford, South Australia, Australia

Box Hill Hospital, 4th Floor, Clive Ward Centre; 🇦🇺 Box Hill, Victoria, Australia

Royal Hobart Hospital; 🇦🇺 Hobart, Tasmania, Australia

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Victoria, Australia

St Vincents Hospital; 🇦🇺 Fitzroy, Victoria, Australia

KUL; 🇧🇪 Leuven, Belgium

CHU Hôtel Dieu; 🇫🇷 Nantes, Cedex 01, France

Hôpital Bretonneau; 🇫🇷 Tours, Cédex 1, France

Hôpital Claude Huriez; 🇫🇷 Place De Verdun Cedex, Lille, France

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia

Hôpital Lapeyronie; 🇫🇷 Cedex, Montpellier, France

Centre Hospitalier Lyon Sud; 🇫🇷 Lyon Sud, Pierre-Bénite, France

Hopital Michallon; 🇫🇷 Grenoble, France

Hôpital N.D.de Bon Secours; 🇫🇷 Metz, France

Centre René Huguenin; 🇫🇷 Saint Cloud, France

Centre Hospitalier; 🇫🇷 Valence, France

Cancer Center of Kansas; 🇺🇸 Wichita, Kansas, United States

Hôtel Dieu Pavillon Villemur Pasteur; 🇫🇷 Clermont-Ferrand, France

CHU Dupuytren; 🇫🇷 Limoges, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Hôpital Necker; 🇫🇷 Paris, France

Hopital Henri Mondor; 🇫🇷 Creteil, France

CHU de Dijon; 🇫🇷 Dijon, France

CHD Les Oudairies; 🇫🇷 La Roche Sur Yon, France

Centre Henri Becquerel; 🇫🇷 Rouen, France