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Lymphoma, Non-Hodgkin'sPhase 2NCT00413036

A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma

A Phase 2 study testing lenalidomide in people with Lymphoma, Non-Hodgkin's, run by Celgene at 53 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin's
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
217 participants
Where
53 sitesin 7 countries
Study dates
Jun 2006to May 2011
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

  • Biopsy proven aggressive non-hodgkin's lymphoma
  • Follicular center lymphoma Grade 3.
  • Diffuse large B-cell lymphoma.
  • Mantle cell lymphoma.
  • Transformed lymphoma.
  • Relapsed or refractory to previous therapy for lymphoma
Show all 10Show fewer
  • At least one prior combination chemotherapy regime
  • Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
  • Willing to follow the pregnancy precautions

Who cannot join

  • Any of the following laboratory abnormalities.
  • Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5*10^9/L).
  • Platelet count < 60,000/mm^3 (60*10^9/L).
  • Calculated creatinine clearance of <50mL/min
  • Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times upper limit of normal (ULN).
  • Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL.
Show all 10Show fewer
  • Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
  • History of active Central Nervous System (CNS) lymphoma within the previous 6 months
  • History of other malignancies within the past year
  • Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C

Trial locations and contacts

53 sites in 7 countries.

53 sites in 7 countries

United States20 sites

  • Ochsner Clinic Foundation

    Baton Rouge, Louisiana, 70809

  • Pasco Hernando Oncology Associates

    Brooksville, Florida, 34613

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • Family Cancer Center

    Collierville, Tennessee, 38017

  • Lalita Pandit, MD, Inc

    Fountain Valley, California, 92708

  • Sylvester Cancer Center/ Univeristy of Miami

    Miami, Florida, 33136

  • Northwest Alabama Cancer Center, PC

    Muscle Shoals, Alabama, 35661

  • Cancer Care Center, Inc.

    New Albany, Indiana, 47150

  • University of Nebraska

    Omaha, Nebraska, 68198

  • HIllman Cancer Center -UPMC

    Pittsburgh, Pennsylvania, 15232

  • Access Clinical Research

    Rancho Mirage, California, 92270

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Hematology Oncology Associates of Central Brevard

    Rockledge, Florida, 32955

  • Kaiser Permanente Medical Group

    San Diego, California, 92120

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • Michigan Hematology and Oncology Institute

    Southgate, Michigan, 48195

  • Palmetto Hematology Oncology

    Spartanburg, South Carolina, 29303

  • Our Lady of Mercy Cancer Center

    The Bronx, New York, 10466

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

Other trials in United States

France8 sites

  • Service d'Hématologie Clinique

    Créteil, 94010

  • Clinical Haematology Department

    Dijon, 21034

  • Institute Paoli-Calmettes Départmentd 'Hématologie

    Marseille, 13273

  • CHU Hopital Lapeyronie, Hematologie et Oncologie Medicale

    Montpellier, 34295

  • Hopital Saint Louis Service d'Hémato-Oncologie

    Paris, 75 475

  • Hopital du Haut-Lévèque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud, Hematologie Clinique

    Pierre-Bénite, 69310

  • Department d'Hématologie Centre Henri Becquerel

    Rouen, 76 038

Other trials in France

Spain8 sites

  • Hospital Clinic I Provincial, Servicio de Hematologia

    Barcelona, 08036

  • Hospital Clinicio San Carlos, Servivio de Hematologia Clinica

    Madrid, 28040

  • Hospital Universitario 12 de Octubre,

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria, Servicio de oncologia

    Málaga, 29010

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Complexo Hospitalario de Pontevedra Oncology Department

    Pontevedra, 36001

  • Hospital Clinico Universitario de Salamanca, Servicio de Hematologia

    Salamanca, 37007

  • Research Site

    Valencia

Other trials in Spain

Germany6 sites

  • Research Site

    Berlin

  • Research Site

    Cologne

  • Universitaetsklinikum Essen

    Essen, 45122

  • Research Site

    Göttingen

  • Research Site

    Heidelberg

  • Research Site

    Homburg

Other trials in Germany

Italy5 sites

  • Institute of Hematology and Medical Oncology "L. & A. Seràgnoli"

    Bologna, 40138

  • O.U. di Clinica Ematologica

    Genova, 16132

  • Ospedale Policlinico S. Matteo

    Pavia, 27100

  • Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina

    Roma, 56127

  • Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),

    Torino, 10126

Other trials in Italy

Canada3 sites

  • London Health Science Center

    London, Ontario

  • Saskatoon Cancer Center

    Saskatoon, Saskatchewan

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, M4N 3M5

Other trials in Canada

United Kingdom3 sites

  • Somers Cancer Research Building

    Southampton, SO16 6YD

  • Royal Marsden Hospital NHS Foundation Trust London and Surrey

    Surrey, SM2 5PT

  • Medical Oncology, Christie Hospital NHS Trust

    Withington, M20 4BX

Other trials in United Kingdom

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®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

Being tested
lenalidomide
Keywords
Celgene, Revlimid, CC-5013, Non-hodgkin's lymphoma, Lenalidomide, CC5013, NHL
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

Study groups in NCT00413036
Study groupRoleWhat they receive
lenalidomideExperimental25 mg oral lenalidomide once daily on Days 1-21 every 28 days
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 Central Review

    Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.

    • Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
    • Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
    • Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
    • Stable Disease(SD): Less than PR, but not progressive disease.
    • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.

    Measured: Up to 1459 days

Secondary outcomes (4)

  1. Duration of Response as Determined by Central Review

    Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.

    For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting.

    Measured: Up to 1459 days

  2. Time to Progression as Determined by Central Review

    Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.

    Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.

    • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.

    Measured: Up to 1459 days

  3. Progression-free Survival as Determined by Central Review

    Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.

    Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.

    • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.

    Measured: Up to 1459 days

  4. Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review

    Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.

    • Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
    • Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
    • Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
    • Stable Disease(SD): Less than PR, but not progressive disease.

    Measured: Up to 1459 days

Timeline

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

  1. First posted19 Dec 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionApr 2011
  4. Study completionMay 2011

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
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00413036
Sponsor's protocol ID
CC-5013-NHL-003
Status last verified
Jan 2017
First submitted
18 Dec 2006
Last updated
1 Mar 2017
Data monitoring committee
Yes

Publications

  • Zinzani PL, Vose JM, Czuczman MS, Reeder CB, Haioun C, Polikoff J, Tilly H, Zhang L, Prandi K, Li J, Witzig TE. Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study. Ann Oncol. 2013 Nov;24(11):2892-7. doi: 10.1093/annonc/mdt366. Epub 2013 Sep 12.

    PubMed 24030098

  • Witzig TE, Vose JM, Zinzani PL, Reeder CB, Buckstein R, Polikoff JA, Bouabdallah R, Haioun C, Tilly H, Guo P, Pietronigro D, Ervin-Haynes AL, Czuczman MS. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011 Jul;22(7):1622-1627. doi: 10.1093/annonc/mdq626. Epub 2011 Jan 12.

    PubMed 21228334

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lenalidomide in people with Lymphoma, Non-Hodgkin's, run by Celgene at 53 sites in 7 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, France, Spain, Germany, Italy and 2 more countries. 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 11 Apr 2013). 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 Central Review (time frame: Up to 1459 days). 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 NCT00413036, which also lists 2 linked publications.

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 1 Mar 2017.

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