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Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma. (MAGNIFY)

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenalidomide
Rituximab
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Lymphoma, Mantle cell Lymphoma, Follicular Lymphoma, Marginal zone Lymphoma, Lenalidomide treatment, rituximab treatment, Non Hodgkins Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

-- Age ≥18 years

  • Histologically confirmed Follicular Lymphoma (FL, Grade 1, 2, 3a, or 3b), Transformed FL, Marginal Zone Lymphoma, or Mantle Cell Lymphoma
  • Must have documented relapsed, refractory or Progressive Disease after last treatment with systemic therapy
  • Bi-dimensionally measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance status < 2
  • Adequate bone marrow function
  • Willingness to follow pregnancy precautions

Exclusion Criteria:

  • Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma
  • Any medical condition (other than the underlying lymphoma) that requires chronic steroid use
  • Subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone
  • Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 4 weeks use of radioimmunotherapy within 3 months
  • Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)
  • Known sensitivity or allergy to murine products
  • Presence or history of central nervous system involvement by lymphoma. Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it
  • Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Local Institution - 055
  • Local Institution - 077
  • Local Institution - 079
  • John Muir Health
  • Bay Area Cancer Research Group, LLC
  • Sutter Hematology and Oncology
  • Local Institution - 032
  • Local Institution - 130
  • Local Institution - 052
  • Local Institution - 106
  • Colorado Cancer Research Program
  • Local Institution - 062
  • Praxair Cancer Center Danbury
  • Medical Oncology and Blood Disorders, LLP
  • Local Institution - 041
  • Hematology Oncology Associates, PC
  • Local Institution - 149
  • Local Institution - 116
  • Cancer Specialists, LLC dba Cancer Specialists of North Florida
  • Mount Sinai Comprehensive Cancer Center
  • Local Institution - 054
  • Sacred Heart Medical Oncology Group
  • Local Institution - 011
  • Local Institution - 083
  • Local Institution - 108
  • United States Department of Veterans Affairs - VA Great Lakes Health Care System - Edward Hines Jr
  • Local Institution - 159
  • Local Institution - 056
  • Local Institution - 028
  • Orchard Healthcare Research Inc.
  • American Health Network of Indiana, LLC
  • McFarland Clinic
  • Siouxland Hematology-Oncology Associates, LLP
  • Cedar Valley Medical Specialists
  • Local Institution - 019
  • Local Institution - 350
  • Kentucky Cancer Clinic
  • Local Institution - 138
  • Maine General Medical Center
  • Anne Arundel Medical Center
  • Local Institution - 030
  • Associates Of Oncology/Hematology, P.C.
  • Local Institution - 051
  • Local Institution - 033
  • Local Institution - 164
  • Local Institution - 050
  • Local Institution - 103
  • Local Institution - 042
  • Mercy Medical Research Institute
  • Local Institution - 003
  • Local Institution - 098
  • Summit Medical Group Overlook Oncology Center
  • Veterans Affairs New Jersey Health Care System
  • Local Institution - 080
  • Regional Cancer Care Associates LLC
  • Saint Peter'S University Hospital
  • Brookdale University Hospital and Medical Center
  • C.R. Wood Cancer Center at Glens Falls Hospital
  • Broome Oncology, LLC
  • Local Institution - 152
  • Local Institution - 023
  • Local Institution - 039
  • Summa Health System Akron City Hospital Laboratory
  • Aultman Hospital
  • Local Institution - 161
  • Local Institution - 047
  • Local Institution - 045
  • Toledo Clinic Cancer Center
  • Local Institution - 037
  • Local Institution - 059
  • Hematology Oncology Associates, P.C.
  • Local Institution - 073
  • Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
  • Rapid City Regional Hospital
  • Local Institution - 153
  • Baptist Cancer Center
  • Local Institution - 076
  • Texas Oncology, P.A.- Amarillo
  • Arlington Cancer Center
  • Texas Oncology-Arlington South
  • Local Institution - 105
  • Local Institution - 026
  • Local Institution - 067
  • Local Institution - 008
  • Texas Health Physicians Group
  • Local Institution - 071
  • Local Institution - 070
  • Local Institution - 058
  • Local Institution - 111
  • Tyler Hematology and Oncology
  • Local Institution - 163
  • Texas Oncology, P.A. - Deke Slayton Cancer Center
  • Local Institution - 090
  • Rutland Regional Medical Center
  • Local Institution - 053
  • Fort Belvoir Community Hospital
  • Local Institution - 081
  • Cancer Treatment Center of America
  • PeaceHealth St. Joseph Medical Center
  • Local Institution - 049
  • Local Institution - 119
  • Seattle Cancer Care Alliance
  • Local Institution - 104
  • Local Institution - 099
  • Local Institution - 006
  • Local Institution - 038
  • Aurora Health Care Aurora Research
  • Local Institution - 301
  • Local Institution - 300
  • Local Institution - 101
  • Local Institution - 208
  • Local Institution - 202
  • Local Institution - 205
  • Local Institution - 211
  • Local Institution - 200
  • Local Institution - 203
  • Local Institution - 206
  • Local Institution - 213
  • Local Institution - 210
  • Local Institution - 204
  • Local Institution - 215
  • Local Institution - 212
  • Local Institution - 201
  • Local Institution - 207
  • Local Institution - 209
  • Local Institution - 029

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Lenalidomide + rituximab followed by lenalidomide

Arm B: Lenalidomide + rituximab followed by rituximab

Arm Description

Induction Period (12 cycles): Lenalidomide 20mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60mL/min) by mouth (PO) daily (QD) on Days 1 to 21 of every 28-day cycle during cycles 1 through 12 and rituximab 375mg/m^2 intraveneously (IV) every week in Cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period (lasting 18 Cycles) that includes Lenalidomide 10 mg PO QD on Days 1 to 21 of every 28-day cycle during cycles 13 to 30 and rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29 followed by an optional Maintenance Period (up to Progressive Disease) receiving Lenalidomide 10mg PO QD on Days 1 through 21 of every 28 day cycle until the disease progresses

Induction Period (12 Cycles): Lenalidomide 20 mg PO QD (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) on Days 1 to 21 of every 28-day cycle during cycles 1 to 12 and rituximab 375 mg/m^2 IV every week in cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period for 18 Cycles that includes: Rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29

Outcomes

Primary Outcome Measures

Progression free survival (PFS) for Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL)
Progression free survival is defined as the time from the first dose date of maintenance therapy to objective disease progression or death from any cause

Secondary Outcome Measures

Overall Survival
Overall Survival is defined as the time between the first dose date of maintenance therapy and death from any cause
Improvement of Response
Improvement of response is defined as the proportion of participants who have improved their tumor response during the maintenance phase
Overall response rate
Overall response rate is defined as proportion of subjects with a best response of at least partial remission (including partial remission, complete remission and unconfirmed complete remission).
Complete response rate
Complete response rate is defined as proportion of subjects with a best response of at least unconfirmed complete remission (including complete remission and unconfirmed complete remission)
Duration of response
Duration of response is defined as the time from the initial response (at least partial remission) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death
Duration of complete response
Duration of complete response is defined as the time from the initial response (at least CRu) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death
Time to next anti-lymphoma treatment
Time to next anti-lymphoma treatment is defined as the time from the first dose date of maintenance therapy to the time of first documented administration of new anti-lymphoma therapy
Time to histological transformation
Time to histological transformation is defined as the time from the first dose date of maintenance therapy to the time of histological transformation as measured based on documentation of histological transformation
Adverse Events
Number of participants with adverse events

Full Information

First Posted
November 22, 2013
Last Updated
September 27, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT01996865
Brief Title
Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
Acronym
MAGNIFY
Official Title
A Phase 3B Randomized Study of Lenalidomide (CC-5013) Plus Rituximab Maintenance Therapy Followed by Lenalidomide Single-Agent Maintenance Versus Rituximab Maintenance in Subjects With Relapsed/Refractory Follicular, Marginal Zone, or Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
October 16, 2023 (Anticipated)
Study Completion Date
July 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.
Detailed Description
MAGNIFY (NCT01996865) is a phase 3b, multicenter, open-label study of patients with grades 1-3b or transformed follicular lymphoma (FL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL) who received ≥1 prior therapy and had stage I-IV, measurable disease. ~500 patients are planned for enrollment in 12 cycles of R2 induction, with a projected ~314 patients with ≥SD after induction randomized (1:1) to two maintenance arms. Induction includes oral lenalidomide 20 mg/day, days 1-21 per 28-day cycle (d1-21/28) plus IV rituximab 375 mg/m2, days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 3, 5, 7, 9, and 11 (28-day cycles). Patients are then randomized to maintenance lenalidomide 10 mg/day, d1-21/28, cycles 13-30, plus rituximab 375 mg/m2, day 1 of cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29 (R2, Arm A), or rituximab alone (same schedule, Arm B). Patients receiving R2 maintenance after 18 cycles may continue maintenance lenalidomide monotherapy 10 mg/day, d1-21/28 (per patient and/or investigator discretion), until disease progression as tolerated. The primary endpoint is progression-free survival (per modified 1999 IWG criteria). Secondary endpoints include safety, overall survival, response rates, duration of response, and quality of life (exploratory). Patients will be followed for ≥5 years after the last patient initiated induction therapy. Enrollment in MAGNIFY began in March 2014; as of Jan 2016, 133 patients are enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Lymphoma, Mantle cell Lymphoma, Follicular Lymphoma, Marginal zone Lymphoma, Lenalidomide treatment, rituximab treatment, Non Hodgkins Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Lenalidomide + rituximab followed by lenalidomide
Arm Type
Experimental
Arm Description
Induction Period (12 cycles): Lenalidomide 20mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60mL/min) by mouth (PO) daily (QD) on Days 1 to 21 of every 28-day cycle during cycles 1 through 12 and rituximab 375mg/m^2 intraveneously (IV) every week in Cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period (lasting 18 Cycles) that includes Lenalidomide 10 mg PO QD on Days 1 to 21 of every 28-day cycle during cycles 13 to 30 and rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29 followed by an optional Maintenance Period (up to Progressive Disease) receiving Lenalidomide 10mg PO QD on Days 1 through 21 of every 28 day cycle until the disease progresses
Arm Title
Arm B: Lenalidomide + rituximab followed by rituximab
Arm Type
Active Comparator
Arm Description
Induction Period (12 Cycles): Lenalidomide 20 mg PO QD (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) on Days 1 to 21 of every 28-day cycle during cycles 1 to 12 and rituximab 375 mg/m^2 IV every week in cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period for 18 Cycles that includes: Rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
CC-5013, Revlimid
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Primary Outcome Measure Information:
Title
Progression free survival (PFS) for Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL)
Description
Progression free survival is defined as the time from the first dose date of maintenance therapy to objective disease progression or death from any cause
Time Frame
Up to 8 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival is defined as the time between the first dose date of maintenance therapy and death from any cause
Time Frame
10 years
Title
Improvement of Response
Description
Improvement of response is defined as the proportion of participants who have improved their tumor response during the maintenance phase
Time Frame
8 years
Title
Overall response rate
Description
Overall response rate is defined as proportion of subjects with a best response of at least partial remission (including partial remission, complete remission and unconfirmed complete remission).
Time Frame
8 years
Title
Complete response rate
Description
Complete response rate is defined as proportion of subjects with a best response of at least unconfirmed complete remission (including complete remission and unconfirmed complete remission)
Time Frame
8 years
Title
Duration of response
Description
Duration of response is defined as the time from the initial response (at least partial remission) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death
Time Frame
8 years
Title
Duration of complete response
Description
Duration of complete response is defined as the time from the initial response (at least CRu) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death
Time Frame
8 years
Title
Time to next anti-lymphoma treatment
Description
Time to next anti-lymphoma treatment is defined as the time from the first dose date of maintenance therapy to the time of first documented administration of new anti-lymphoma therapy
Time Frame
8 years
Title
Time to histological transformation
Description
Time to histological transformation is defined as the time from the first dose date of maintenance therapy to the time of histological transformation as measured based on documentation of histological transformation
Time Frame
8 years
Title
Adverse Events
Description
Number of participants with adverse events
Time Frame
Up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -- Age ≥18 years Histologically confirmed Follicular Lymphoma (FL, Grade 1, 2, 3a, or 3b), Transformed FL, Marginal Zone Lymphoma, or Mantle Cell Lymphoma Must have documented relapsed, refractory or Progressive Disease after last treatment with systemic therapy Bi-dimensionally measurable disease Eastern Cooperative Oncology Group (ECOG) Performance status < 2 Adequate bone marrow function Willingness to follow pregnancy precautions Exclusion Criteria: Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma Any medical condition (other than the underlying lymphoma) that requires chronic steroid use Subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 4 weeks use of radioimmunotherapy within 3 months Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) Known sensitivity or allergy to murine products Presence or history of central nervous system involvement by lymphoma. Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study Other protocol-defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 055
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Local Institution - 077
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Local Institution - 079
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
John Muir Health
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Bay Area Cancer Research Group, LLC
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
Sutter Hematology and Oncology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Local Institution - 032
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Local Institution - 130
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Local Institution - 052
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Local Institution - 106
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Colorado Cancer Research Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Local Institution - 062
City
Glenwood Springs
State/Province
Colorado
ZIP/Postal Code
81601
Country
United States
Facility Name
Praxair Cancer Center Danbury
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Medical Oncology and Blood Disorders, LLP
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
Facility Name
Local Institution - 041
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Hematology Oncology Associates, PC
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Local Institution - 149
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Local Institution - 116
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
067014
Country
United States
Facility Name
Cancer Specialists, LLC dba Cancer Specialists of North Florida
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Local Institution - 054
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Sacred Heart Medical Oncology Group
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Local Institution - 011
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Local Institution - 083
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Local Institution - 108
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
United States Department of Veterans Affairs - VA Great Lakes Health Care System - Edward Hines Jr
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Local Institution - 159
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Local Institution - 056
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Local Institution - 028
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Orchard Healthcare Research Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
Cedar Valley Medical Specialists
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50701
Country
United States
Facility Name
Local Institution - 019
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Local Institution - 350
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Local Institution - 138
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Maine General Medical Center
City
Waterville
State/Province
Maine
ZIP/Postal Code
04901
Country
United States
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Local Institution - 030
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Associates Of Oncology/Hematology, P.C.
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Local Institution - 051
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Local Institution - 033
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Local Institution - 164
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Local Institution - 050
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Local Institution - 103
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Local Institution - 042
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Medical Research Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Local Institution - 003
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Local Institution - 098
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Summit Medical Group Overlook Oncology Center
City
Berkeley Heights
State/Province
New Jersey
ZIP/Postal Code
07922
Country
United States
Facility Name
Veterans Affairs New Jersey Health Care System
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Local Institution - 080
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Regional Cancer Care Associates LLC
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Saint Peter'S University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Brookdale University Hospital and Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
C.R. Wood Cancer Center at Glens Falls Hospital
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
Broome Oncology, LLC
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Local Institution - 152
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Local Institution - 023
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501-1584
Country
United States
Facility Name
Local Institution - 039
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Summa Health System Akron City Hospital Laboratory
City
Akron
State/Province
Ohio
ZIP/Postal Code
44202
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Local Institution - 161
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Local Institution - 047
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Local Institution - 045
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Toledo Clinic Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Local Institution - 037
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Local Institution - 059
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Hematology Oncology Associates, P.C.
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Local Institution - 073
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Local Institution - 153
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Baptist Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Local Institution - 076
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Texas Oncology, P.A.- Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Texas Oncology-Arlington South
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Local Institution - 105
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Local Institution - 026
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 067
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 008
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Texas Health Physicians Group
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Local Institution - 071
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Local Institution - 070
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Local Institution - 058
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Local Institution - 111
City
Temple
State/Province
Texas
ZIP/Postal Code
66205
Country
United States
Facility Name
Tyler Hematology and Oncology
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Local Institution - 163
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texas Oncology, P.A. - Deke Slayton Cancer Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598-4420
Country
United States
Facility Name
Local Institution - 090
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Rutland Regional Medical Center
City
Rutland
State/Province
Vermont
ZIP/Postal Code
05701
Country
United States
Facility Name
Local Institution - 053
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
Local Institution - 081
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Cancer Treatment Center of America
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23704
Country
United States
Facility Name
PeaceHealth St. Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Local Institution - 049
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98332
Country
United States
Facility Name
Local Institution - 119
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution - 104
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Local Institution - 099
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Local Institution - 006
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Local Institution - 038
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Aurora Health Care Aurora Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Local Institution - 301
City
Mukwonago
State/Province
Wisconsin
ZIP/Postal Code
53145
Country
United States
Facility Name
Local Institution - 300
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Local Institution - 101
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188-5099
Country
United States
Facility Name
Local Institution - 208
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Local Institution - 202
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Facility Name
Local Institution - 205
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Local Institution - 211
City
Frechen
ZIP/Postal Code
50226
Country
Germany
Facility Name
Local Institution - 200
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Local Institution - 203
City
Hannover
ZIP/Postal Code
30171
Country
Germany
Facility Name
Local Institution - 206
City
Kassel
ZIP/Postal Code
34119
Country
Germany
Facility Name
Local Institution - 213
City
Köln
ZIP/Postal Code
50677
Country
Germany
Facility Name
Local Institution - 210
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Local Institution - 204
City
Munchen
ZIP/Postal Code
81241
Country
Germany
Facility Name
Local Institution - 215
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Local Institution - 212
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution - 201
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Local Institution - 207
City
Ravensberg
ZIP/Postal Code
88212
Country
Germany
Facility Name
Local Institution - 209
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution - 029
City
San Juan
ZIP/Postal Code
00919-1227
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
30897038
Citation
Leonard JP, Trneny M, Izutsu K, Fowler NH, Hong X, Zhu J, Zhang H, Offner F, Scheliga A, Nowakowski GS, Pinto A, Re F, Fogliatto LM, Scheinberg P, Flinn IW, Moreira C, Cabecadas J, Liu D, Kalambakas S, Fustier P, Wu C, Gribben JG; AUGMENT Trial Investigators. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2019 May 10;37(14):1188-1199. doi: 10.1200/JCO.19.00010. Epub 2019 Mar 21.
Results Reference
background
PubMed Identifier
30919940
Citation
Becnel MR, Nastoupil LJ, Samaniego F, Davis RE, You MJ, Green M, Hagemeister FB, Fanale MA, Fayad LE, Westin JR, Wang M, Oki Y, Forbes SG, Feng L, Neelapu SS, Fowler NH. Lenalidomide plus rituximab (R2 ) in previously untreated marginal zone lymphoma: subgroup analysis and long-term follow-up of an open-label phase 2 trial. Br J Haematol. 2019 Jun;185(5):874-882. doi: 10.1111/bjh.15843. Epub 2019 Mar 28.
Results Reference
background
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.

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