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T-cell Non-Hodgkin's LymphomaPhase 2EXPECTNCT00655668

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

A Phase 2 study testing Lenalidomide in people with T-cell Non-Hodgkin's Lymphoma, run by Celgene at 45 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
T-cell Non-Hodgkin's Lymphoma
What is being tested?
Lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
45 sitesin 4 countries
Study dates
1 Mar 2008to 1 Apr 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.

Trial locations and contacts

45 sites in 4 countries.

45 sites in 4 countries

France23 sites

  • CHU Hôpital Hôtel Dieu

    Angers, Cédex 9, 49033

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33000

  • Hôpital Lapeyronie

    Cedex, Montpellier, 34295

  • Hôtel Dieu Pavillon Villemur Pasteur

    Clermont-Ferrand, 63000

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU de Dijon

    Dijon, 21000

  • Hopital Michallon

    Grenoble, 38043

  • CHD Les Oudairies

    La Roche-sur-Yon, 85000

  • CHU Dupuytren

    Limoges, 87042

  • Centre Hospitalier Lyon Sud

    Lyon Sud, Pierre-Bénite, 69495

  • Hôpital N.D.de Bon Secours

    Metz, 57000

  • CHU Hôtel Dieu

    Nantes, Cedex 01, 44093

  • Hôpital Saint-Louis

    Paris, 75010

  • Hôpital Necker

    Paris, 75015

  • Hôpital de la Pitié Salpétriere

    Paris, 75651

  • Hôpital Claude Huriez

    Place de Verdun Cedex, Lille, 59037

  • CHU Rennes Hôpital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre René Huguenin

    Saint-Cloud, 92210

  • Hôpital Purpan

    Toulouse, 31059

  • Hôpital Bretonneau

    Tours, Cédex 1, 37044

  • Centre Hospitalier

    Valence, 26953

  • CHRU Hôpitaux de Brabois - Hématologie

    Vandœuvre-lès-Nancy, Rue Morvan Cedex, 54511

Other trials in France

Australia13 sites

  • Ashford Cancer Centre

    Ashford, South Australia, 5035

  • Box Hill Hospital, 4th Floor, Clive Ward Centre

    Box Hill, Victoria, 3128

  • Clinical Research Unit Cairns Base Hospital

    Cairns, Queensland, 4870

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • The Townsville Hospital

    Douglas, Queensland, 4814

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • St Vincents Hospital

    Fitzroy, Victoria, 3065

  • The Canberra Hospital Building 3, L 2

    Garran, Australian Capital Territory, 2605

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Cancer Therapy Centre

    Liverpool, New South Wales, 2170

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Royal Adelaide Hospital L3 East Wing

    North Terrace, South Australia, 5000

Other trials in Australia

Belgium5 sites

  • Institute Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires St Luc

    Brussels, 1200

  • KUL

    Leuven, 3000

  • Clinique St Pierre

    Ottignies, 1340

  • Cliniques universitaires UCL de Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

United States4 sites

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211-1850

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

About this study

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

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.

Read more

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.
Read the 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.

Being tested
Lenalidomide
Keywords
NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma
Medical subject headings
Lymphoma, T-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid

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

Study groups in NCT00655668
Study groupRoleWhat they receive
LenalidomideExperimentalOpen-label, oral lenalidomide monotherapy
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 24 months

Secondary outcomes (4)

  1. 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.

    Measured: Up to 24 months

  2. 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.

    Measured: Up to 24 months

  3. 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.

    Measured: Up to 24 months

  4. 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.)

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2008 (estimated)
  2. Study start1 Mar 2008
  3. Primary completion1 Mar 2010
  4. Study completion1 Apr 2010

Why it stopped: Decision not to pursue as single agent in the study population.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00655668
Sponsor's protocol ID
CC-5013-TCL-001
Other IDs
2007-002171-13
Acronym
EXPECT
Status last verified
Nov 2019
First submitted
4 Apr 2008
Last updated
25 Nov 2019
Data monitoring committee
Yes

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.

    PubMed 23731832

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide in people with T-cell Non-Hodgkin's Lymphoma, run by Celgene at 45 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France, Australia, Belgium, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants Categorized by Best Response as Determined by Investigator (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00655668, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.

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