Back to resultsA Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
Primary Purpose
Lymphoma, Non-Hodgkin's
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin's focused on measuring Celgene, Revlimid, CC-5013, Non-hodgkin's lymphoma, Lenalidomide, CC5013, NHL
Eligibility Criteria
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
Sites / Locations
- Northwest Alabama Cancer Center, PC
- Mayo Clinic Scottsdale
- Lalita Pandit, MD, Inc
- Access Clinical Research
- Kaiser Permanente Medical Group
- Pasco Hernando Oncology Associates
- Sylvester Cancer Center/ Univeristy of Miami
- Hematology Oncology Associates of Central Brevard
- Palm Beach Cancer Institute
- Cancer Care Center, Inc.
- Ochsner Clinic Foundation
- Michigan Hematology and Oncology Institute
- Mayo Clinic
- University of Nebraska
- Center for Cancer and Hematologic Disease
- Our Lady of Mercy Cancer Center
- Roswell Park Cancer Institute
- HIllman Cancer Center -UPMC
- Palmetto Hematology Oncology
- Family Cancer Center
- London Health Science Center
- Saskatoon Cancer Center
- Toronto Sunnybrook Regional Cancer Centre
- Service d'Hématologie Clinique
- Clinical Haematology Department
- Institute Paoli-Calmettes Départmentd 'Hématologie
- CHU Hopital Lapeyronie, Hematologie et Oncologie Medicale
- Hopital Saint Louis Service d'Hémato-Oncologie
- Hopital du Haut-Lévèque
- Centre Hospitalier Lyon Sud, Hematologie Clinique
- Department d'Hématologie Centre Henri Becquerel
- Research Site
- Universitaetsklinikum Essen
- Research Site
- Research Site
- Research Site
- Research Site
- Institute of Hematology and Medical Oncology "L. & A. Seràgnoli"
- O.U. di Clinica Ematologica
- Ospedale Policlinico S. Matteo
- Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina
- Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),
- Hospital Clinic I Provincial, Servicio de Hematologia
- Hospital Clinicio San Carlos, Servivio de Hematologia Clinica
- Hospital Universitario 12 de Octubre,
- Hospital Universitario Virgen de la Victoria, Servicio de oncologia
- Clinica Universitaria de Navarra
- Complexo Hospitalario de Pontevedra Oncology Department
- Hospital Clinico Universitario de Salamanca, Servicio de Hematologia
- Research Site
- Somers Cancer Research Building
- Royal Marsden Hospital NHS Foundation Trust London and Surrey
- Medical Oncology, Christie Hospital NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lenalidomide
Arm Description
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00413036
Brief Title
A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin's
Keywords
Celgene, Revlimid, CC-5013, Non-hodgkin's lymphoma, Lenalidomide, CC5013, NHL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lenalidomide
Arm Type
Experimental
Arm Description
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
once daily oral capsule
Primary Outcome Measure Information:
Title
Participants Categorized by Best Response as Determined by Central Review
Description
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.
Time Frame
Up to 1459 days
Secondary Outcome Measure Information:
Title
Duration of Response as Determined by Central Review
Description
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.
Time Frame
Up to 1459 days
Title
Time to Progression as Determined by Central Review
Description
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.
Time Frame
Up to 1459 days
Title
Progression-free Survival as Determined by Central Review
Description
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.
Time Frame
Up to 1459 days
Title
Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review
Description
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.
Time Frame
Up to 1459 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Zhang, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Alabama Cancer Center, PC
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Lalita Pandit, MD, Inc
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Access Clinical Research
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Pasco Hernando Oncology Associates
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Sylvester Cancer Center/ Univeristy of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Hematology Oncology Associates of Central Brevard
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Cancer Care Center, Inc.
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Ochsner Clinic Foundation
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Michigan Hematology and Oncology Institute
City
Southgate
State/Province
Michigan
ZIP/Postal Code
48195
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Center for Cancer and Hematologic Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Our Lady of Mercy Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
HIllman Cancer Center -UPMC
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Palmetto Hematology Oncology
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Family Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
London Health Science Center
City
London
State/Province
Ontario
Country
Canada
Facility Name
Saskatoon Cancer Center
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Service d'Hématologie Clinique
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Clinical Haematology Department
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Institute Paoli-Calmettes Départmentd 'Hématologie
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CHU Hopital Lapeyronie, Hematologie et Oncologie Medicale
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Saint Louis Service d'Hémato-Oncologie
City
Paris
ZIP/Postal Code
75 475
Country
France
Facility Name
Hopital du Haut-Lévèque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud, Hematologie Clinique
City
Pierre Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Department d'Hématologie Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76 038
Country
France
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Research Site
City
Goettingen
Country
Germany
Facility Name
Research Site
City
Heidelberg
Country
Germany
Facility Name
Research Site
City
Homburg
Country
Germany
Facility Name
Research Site
City
Koeln
Country
Germany
Facility Name
Institute of Hematology and Medical Oncology "L. & A. Seràgnoli"
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
O.U. di Clinica Ematologica
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina
City
Roma
ZIP/Postal Code
56127
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Hospital Clinic I Provincial, Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinicio San Carlos, Servivio de Hematologia Clinica
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre,
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria, Servicio de oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complexo Hospitalario de Pontevedra Oncology Department
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca, Servicio de Hematologia
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Somers Cancer Research Building
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden Hospital NHS Foundation Trust London and Surrey
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Medical Oncology, Christie Hospital NHS Trust
City
Withington
ZIP/Postal Code
M20 4BX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24030098
Citation
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.
Results Reference
result
PubMed Identifier
21228334
Citation
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.
Results Reference
result
Learn more about this trial
A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
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