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

T-cell Non-Hodgkin's Lymphoma Clinical Trial

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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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00655668
• Other study ID #: CC-5013-TCL-001
• Secondary ID: 2007-002171-13
• Status: Terminated
• Phase: Phase 2
• Start date: March 1, 2008
• Est. completion date: April 1, 2010

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: April 1, 2010
• Est. primary completion date: March 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell
• T-cell Non-Hodgkin's Lymphoma

Intervention

Drug:
• Lenalidomide
Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle

Locations

Country	Name	City	State
Australia	Ashford Cancer Centre	Ashford	South Australia
Australia	Box Hill Hospital, 4th Floor, Clive Ward Centre	Box Hill	Victoria
Australia	Clinical Research Unit Cairns Base Hospital	Cairns	Queensland
Australia	Monash Medical Centre	Clayton	Victoria
Australia	The Townsville Hospital	Douglas	Queensland
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	St Vincents Hospital	Fitzroy	Victoria
Australia	The Canberra Hospital Building 3, L 2	Garran	Australian Capital Territory
Australia	Royal Brisbane & Women's Hospital	Herston	Queensland
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Cancer Therapy Centre	Liverpool	New South Wales
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Royal Adelaide Hospital L3 East Wing	North Terrace	South Australia
Belgium	Cliniques Universitaires St Luc	Bruxelles
Belgium	Institute Jules Bordet	Bruxelles
Belgium	KUL	Leuven
Belgium	Clinique St Pierre	Ottignies
Belgium	Cliniques universitaires UCL de Mont-Godinne	Yvoir
France	CHU Hôpital Hôtel Dieu	Angers	Cédex 9
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Hôpital Lapeyronie	Cedex	Montpellier
France	Hôtel Dieu Pavillon Villemur Pasteur	Clermont-Ferrand
France	Hopital Henri Mondor	Creteil
France	CHU de Dijon	Dijon
France	Hopital Michallon	Grenoble
France	CHD Les Oudairies	La Roche Sur Yon
France	CHU Dupuytren	Limoges
France	Centre Hospitalier Lyon Sud	Lyon Sud	Pierre-Bénite
France	Hôpital N.D.de Bon Secours	Metz
France	CHU Hôtel Dieu	Nantes	Cedex 01
France	Hôpital de la Pitié Salpétriere	Paris
France	Hôpital Necker	Paris
France	Hôpital Saint-Louis	Paris
France	Hôpital Claude Huriez	Place De Verdun Cedex	Lille
France	CHU Rennes Hôpital Pontchaillou	Rennes
France	Centre Henri Becquerel	Rouen
France	Centre René Huguenin	Saint Cloud
France	Hôpital Purpan	Toulouse
France	Hôpital Bretonneau	Tours	Cédex 1
France	Centre Hospitalier	Valence
France	CHRU Hôpitaux de Brabois - Hématologie	Vandoeuvre Les Nancy	Rue Morvan Cedex
United States	Tower Cancer Research Foundation	Beverly Hills	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Cancer Center of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France, 

References & Publications (1)

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 (Rev — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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