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A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial (EMERGE)

Primary Purpose

Mantle Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lenalidomide
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, CC-5013, Revlimid, Lenalidomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy proven mantle cell lymphoma
  • Patients must have documents relapsed, refractory or PD after treatment with bortezomib
  • Must have measureable disease on cross sectional imaging by CT
  • Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2
  • Willing to follow pregnancy precautions

Exclusion Criteria:

  • Any of the following laboratory abnormalities

    • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L)
    • Platelet count < 60,000/mm3 (60 x 109/L)
    • Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma.
    • Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma.
    • Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min
    • Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
    • History of active central nervous system (CNS) lymphoma within the previous 3 months
    • Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis
    • Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 3 years
    • Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C

Sites / Locations

  • University of Arkansas for Medical Sciences
  • UCSD Moores Cancer Center
  • Loma Linda University Medical Center
  • Tower Cancer Research Foundation
  • Boca Raton Community Hospital, Inc., Research Dept.
  • Pasco Hernando Oncology Associates, PA
  • Broward General Medical Center
  • MD Anderson Cancer Center, Orlando Regional Healthcare
  • Lake County Oncology and Hematology
  • Winship Cancer Institute of Emory University
  • Northwestern University
  • Loyola University Medical Center - Smith
  • Indiana University Cancer Center
  • Alvin and Lois Lapidus Cancer Institute Sinai Hospital of Baltimore
  • Tufts Medical Center
  • Beth Israel Deaconess Medical Center
  • University of Massachusetts Medical Center
  • Karmanos Cancer Institute
  • Mayo Clinic
  • Washington University Siteman Cancer Center
  • University of Nebraska
  • Hackensack University Medical Center
  • NYU School of Medicine
  • University of Rochester Cancer Center, James P. Wilmot Cancer Center
  • Presbyterian Hospital
  • Temple University School of Medicine
  • Hillman Cancer Institute at UPMC
  • South Carolina Cancer Specialists
  • Avera Cancer Institute
  • University of Tennessee Cancer Institute
  • University of Virginia Cancer Center Clinical Trials Office
  • Universitaetsklinik Innsbruck
  • Landeskrankenhaus Salzburg
  • Medical University of Vienna
  • AZ Sint-Jan AV Brugge
  • UZ Gent
  • Universitair Ziekenhuis Leuven, Campus Gasthuisberg
  • Hospital Universitario San Ignacio
  • Oncologos del occidente S.A.
  • Hopital Sud, CHU d'Amiens
  • Institut Bergonie
  • Hopital Henri Mondor
  • Hopital Emile Muller
  • Hopital Cochin
  • Institut Curie
  • Hopital Robert Debre
  • Institut de Cancerologie de la Loire
  • Hopital Hautepierre
  • University Hospital Wuerzburg
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
  • University of Debrecen, DEOEC, Institute of Internal Medicine
  • Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat
  • Kaposi Mor Oktato Korhaz
  • Rambam Medical Center
  • Hadassah Medical Center
  • Rabin Medical Center
  • Sheba Medical Center
  • Universita Federico II di Napoli Nuovo Policlinico
  • Ospedale Civile dello Spirito Santo
  • Universita Cattololica del Sacro Cuore
  • Centro De Cancer, Hospital Espanol Auxilio De Puerto Rico
  • Singapore General Hospital
  • Hospital General De Elche
  • Duran i Reynals Institut Catala d'Oncologia
  • Hospital Clinico Universitario de Salamanca
  • Hospital Universitario La Fe
  • Gazi Universitesi
  • Istanbul Universitesi Istanbul
  • Ankara Universitesi Tip Fakultesi
  • Royal Cornwall Hospitals Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide

Arm Description

Single agent Lenalidomide Lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC)
Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 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; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses.
Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee
Kaplan Meier estimate for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment.

Secondary Outcome Measures

Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee
The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other anti-lymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 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.
Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee
Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment.
Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee
Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.
Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee
Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir
Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee
Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data.
Time to Response (TTR)
Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants.
Time to Complete Response (CR+CRu) According to the Independent Review Committee
Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu.
Overall Survival (OS)
Kaplan Meier estimate of overall survival was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following 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; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.

Full Information

First Posted
August 15, 2008
Last Updated
December 11, 2018
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT00737529
Brief Title
A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial
Acronym
EMERGE
Official Title
A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 22, 2008 (Actual)
Primary Completion Date
April 6, 2016 (Actual)
Study Completion Date
November 8, 2017 (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
To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.
Detailed Description
Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. All other efficacy and safety endpoints will be updated at this time. In the unlikely event that the study will be closed and patients are still responding to treatment at this time, Celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation. Follow up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first. 10 October 2017: In regard to the last subject last visit date/study completion date, the prolongation of timelines is due to the bridging of a treatment gap for a patient responding to study medication until non-study medication is available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, CC-5013, Revlimid, Lenalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide
Arm Type
Experimental
Arm Description
Single agent Lenalidomide Lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
25mg oral capsules continuous days 1-21 each of a 28 day cycle
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC)
Description
Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 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; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses.
Time Frame
From Day 1 of study treatment to progession or early treatment discontinuation; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days.
Title
Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee
Description
Kaplan Meier estimate for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment.
Time Frame
From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days.
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee
Description
The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other anti-lymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 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.
Time Frame
From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days
Title
Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee
Description
Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment.
Time Frame
From Day 1 of study drug to progression or early discontinuation; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Title
Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee
Description
Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.
Time Frame
From Day 1 of study drug to first documented date of disease progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Title
Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee
Description
Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir
Time Frame
From Day 1 of study drug to first documented time of progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Title
Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee
Description
Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data.
Time Frame
From Day 1 of study drug to first documented time of treatment failure; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Title
Time to Response (TTR)
Description
Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants.
Time Frame
From Day 1 of study drug to time of first documented PR or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Title
Time to Complete Response (CR+CRu) According to the Independent Review Committee
Description
Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu.
Time Frame
From Day 1 of study drug to first documented CR/CRu or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Title
Overall Survival (OS)
Description
Kaplan Meier estimate of overall survival was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive.
Time Frame
From Day 1 of study drug to first documented date of progressive disease or death; up to the final data cut-off date of 30 March 2017; median duration of follow-up for surviving participants was 62.94 months
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following 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; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.
Time Frame
From the first dose of lenalidomide through 28 days after the last dose during the follow-up phase; median (minimum, maximum) duration of treatment was 94.0 (1.0, 1950 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy proven mantle cell lymphoma Patients must have documents relapsed, refractory or PD after treatment with bortezomib Must have measureable disease on cross sectional imaging by CT Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2 Willing to follow pregnancy precautions Exclusion Criteria: Any of the following laboratory abnormalities Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L) Platelet count < 60,000/mm3 (60 x 109/L) Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma. Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma. Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible History of active central nervous system (CNS) lymphoma within the previous 3 months Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 3 years 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
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Tower Cancer Research Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Boca Raton Community Hospital, Inc., Research Dept.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Pasco Hernando Oncology Associates, PA
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
MD Anderson Cancer Center, Orlando Regional Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Lake County Oncology and Hematology
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Medical Center - Smith
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Alvin and Lois Lapidus Cancer Institute Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-2014
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester Cancer Center, James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Temple University School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Hillman Cancer Institute at UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
South Carolina Cancer Specialists
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
University of Tennessee Cancer Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
University of Virginia Cancer Center Clinical Trials Office
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Universitaetsklinik Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Landeskrankenhaus Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
AZ Sint-Jan AV Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital Universitario San Ignacio
City
Bogota
Country
Colombia
Facility Name
Oncologos del occidente S.A.
City
Pereira
Country
Colombia
Facility Name
Hopital Sud, CHU d'Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Emile Muller
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital Robert Debre
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Institut de Cancerologie de la Loire
City
Saint Jean Priest En Jarez
ZIP/Postal Code
42277
Country
France
Facility Name
Hopital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
University Hospital Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
University of Debrecen, DEOEC, Institute of Internal Medicine
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
35254
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petch Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Universita Federico II di Napoli Nuovo Policlinico
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Civile dello Spirito Santo
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Facility Name
Universita Cattololica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Centro De Cancer, Hospital Espanol Auxilio De Puerto Rico
City
San Juan
ZIP/Postal Code
00919
Country
Puerto Rico
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Hospital General De Elche
City
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Duran i Reynals Institut Catala d'Oncologia
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37003
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Gazi Universitesi
City
Besevler Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Ankara Universitesi Tip Fakultesi
City
Sihhiye Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Royal Cornwall Hospitals Trust
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24002500
Citation
Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, Zhang L, Cicero S, Fu T, Witzig TE. Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study. J Clin Oncol. 2013 Oct 10;31(29):3688-95. doi: 10.1200/JCO.2013.49.2835. Epub 2013 Sep 3.
Results Reference
background
PubMed Identifier
25921098
Citation
Goy A, Kalayoglu Besisik S, Drach J, Ramchandren R, Robertson MJ, Avivi I, Rowe JM, Herbrecht R, Van Hoof A, Zhang L, Cicero S, Fu T, Witzig T. Longer-term follow-up and outcome by tumour cell proliferation rate (Ki-67) in patients with relapsed/refractory mantle cell lymphoma treated with lenalidomide on MCL-001(EMERGE) pivotal trial. Br J Haematol. 2015 Aug;170(4):496-503. doi: 10.1111/bjh.13456. Epub 2015 Apr 28.
Results Reference
result
PubMed Identifier
28699256
Citation
Witzig TE, Luigi Zinzani P, Habermann TM, Tuscano JM, Drach J, Ramchandren R, Kalayoglu Besisik S, Takeshita K, Casadebaig Bravo ML, Zhang L, Fu T, Goy A. Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma. Am J Hematol. 2017 Oct;92(10):E575-E583. doi: 10.1002/ajh.24854. Epub 2017 Aug 28.
Results Reference
result
PubMed Identifier
24019544
Citation
San-Miguel JF, Richardson PG, Gunther A, Sezer O, Siegel D, Blade J, LeBlanc R, Sutherland H, Sopala M, Mishra KK, Mu S, Bourquelot PM, Victoria Mateos M, Anderson KC. Phase Ib study of panobinostat and bortezomib in relapsed or relapsed and refractory multiple myeloma. J Clin Oncol. 2013 Oct 10;31(29):3696-703. doi: 10.1200/JCO.2012.46.7068. Epub 2013 Sep 9.
Results Reference
derived

Learn more about this trial

A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial

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