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

January 17, 2017 updated by: Celgene

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
    • Ontario
      • London, Ontario, Canada
        • London Health Science Center
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Saskatoon Cancer Center
  • France
      • Créteil, France, 94010
        • Service d'Hematologie Clinique
      • Dijon, France, 21034
        • Clinical Haematology Department
      • Marseille, France, 13273
        • Institute Paoli-Calmettes Départmentd 'Hématologie
      • Montpellier, France, 34295
        • CHU Hopital Lapeyronie, Hematologie et Oncologie Medicale
      • Paris, France, 75 475
        • Hopital Saint Louis Service d'Hémato-Oncologie
      • Pessac, France, 33604
        • Hopital Du Haut-Leveque
      • Pierre Bénite, France, 69310
        • Centre Hospitalier Lyon Sud, Hematologie Clinique
      • Rouen, France, 76 038
        • Department d'Hématologie Centre Henri Becquerel
  • Germany
      • Berlin, Germany
        • Research Site
      • Essen, Germany, 45122
        • Universitaetsklinikum Essen
      • Goettingen, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Homburg, Germany
        • Research Site
      • Koeln, Germany
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Institute of Hematology and Medical Oncology "L. & A. Seràgnoli"
      • Genova, Italy, 16132
        • O.U. di Clinica Ematologica
      • Pavia, Italy, 27100
        • Ospedale Policlinico S. Matteo
      • Roma, Italy, 56127
        • Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina
      • Torino, Italy, 10126
        • Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial, Servicio de Hematologia
      • Madrid, Spain, 28040
        • Hospital Clinicio San Carlos, Servivio de Hematologia Clinica
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre,
      • Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria, Servicio de oncologia
      • Pamplona, Spain, 31008
        • Clinica Universitaria De Navarra
      • Pontevedra, Spain, 36001
        • Complexo Hospitalario de Pontevedra Oncology Department
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca, Servicio de Hematologia
      • Valencia, Spain
        • Research Site
  • United Kingdom
      • Southampton, United Kingdom, SO16 6YD
        • Somers Cancer Research Building
      • Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital NHS Foundation Trust London and Surrey
      • Withington, United Kingdom, M20 4BX
        • Medical Oncology, Christie Hospital NHS Trust
  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35661
        • Northwest Alabama Cancer Center, Pc
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Scottsdale
    • California
      • Fountain Valley, California, United States, 92708
        • Lalita Pandit, MD, Inc
      • Rancho Mirage, California, United States, 92270
        • Access Clinical Research
      • San Diego, California, United States, 92120
        • Kaiser Permanente Medical Group
    • Florida
      • Brooksville, Florida, United States, 34613
        • Pasco Hernando Oncology Associates
      • Miami, Florida, United States, 33136
        • Sylvester Cancer Center/ Univeristy of Miami
      • Rockledge, Florida, United States, 32955
        • Hematology Oncology Associates of Central Brevard
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Cancer Care Center, Inc.
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Ochsner Clinic Foundation
    • Michigan
      • Southgate, Michigan, United States, 48195
        • Michigan Hematology and Oncology Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Center for Cancer and Hematologic Disease
    • New York
      • Bronx, New York, United States, 10466
        • Our Lady of Mercy Cancer Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • Pennsylvania
      • Pittsburg, Pennsylvania, United States, 15232
        • HIllman Cancer Center -UPMC
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Palmetto Hematology Oncology
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Family Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion criteria

  • 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
  • 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

Key Exclusion criteria

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lenalidomide
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Drug: lenalidomide
once daily oral capsule
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 Central Review
Time Frame: Up to 1459 days

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.
Up to 1459 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response as Determined by Central Review
Time Frame: Up to 1459 days

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.
Up to 1459 days
Time to Progression as Determined by Central Review
Time Frame: Up to 1459 days

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.
Up to 1459 days
Progression-free Survival as Determined by Central Review
Time Frame: Up to 1459 days

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.
Up to 1459 days
Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review
Time Frame: Up to 1459 days

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.
Up to 1459 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Lei Zhang, MD, Celgene Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

December 18, 2006

First Submitted That Met QC Criteria

December 18, 2006

First Posted (Estimate)

December 19, 2006

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-NHL-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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