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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma, Non-Hodgkin
• Intervention / Treatment: Drug: Rituximab; Drug: Lenalidomide

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.

• Study Type: Interventional
• Enrollment (Actual): 503
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10707
    • Local Institution - 208
  • Bremen, Germany, 28177
    • Local Institution - 202
  • Frankfurt, Germany, 60389
    • Local Institution - 205
  • Frechen, Germany, 50226
    • Local Institution - 211
  • Gießen, Germany, 35392
    • Local Institution - 200
  • Hannover, Germany, 30171
    • Local Institution - 203
  • Kassel, Germany, 34119
    • Local Institution - 206
  • Köln, Germany, 50677
    • Local Institution - 213
  • Marburg, Germany, 35037
    • Local Institution - 210
  • Munchen, Germany, 81241
    • Local Institution - 204
  • Mönchengladbach, Germany, 41063
    • Local Institution - 215
  • Münster, Germany, 48149
    • Local Institution - 212
  • Potsdam, Germany, 14467
    • Local Institution - 201
  • Ravensberg, Germany, 88212
    • Local Institution - 207
  • Würzburg, Germany, 97080
    • Local Institution - 209
• Puerto Rico
  • San Juan, Puerto Rico, 00919-1227
    • Local Institution - 029
• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Local Institution - 055
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Local Institution - 077
  • California
    • Berkeley, California, United States, 94704
      • Local Institution - 079
    • Concord, California, United States, 94520
      • Local Institution - 142
    • Pleasant Hill, California, United States, 94523
      • Bay Area Cancer Research Group, LLC
    • Sacramento, California, United States, 95816
      • Sutter Hematology and Oncology
    • San Diego, California, United States, 92123
      • Local Institution - 032
    • Santa Barbara, California, United States, 93105
      • Local Institution - 130
  • Colorado
    • Boulder, Colorado, United States, 80303
      • Local Institution - 052
    • Denver, Colorado, United States, 80220
      • Local Institution - 106
    • Denver, Colorado, United States, 80222
      • Colorado Cancer Research Program
    • Glenwood Springs, Colorado, United States, 81601
      • Local Institution - 062
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Praxair Cancer Center Danbury
    • Manchester, Connecticut, United States, 06040
      • Medical Oncology and Blood Disorders, LLP
    • Norwalk, Connecticut, United States, 06851
      • Local Institution - 041
    • Stamford, Connecticut, United States, 06902
      • Hematology Oncology Associates, PC
    • Trumbull, Connecticut, United States, 06611
      • Local Institution - 149
    • Waterbury, Connecticut, United States, 067014
      • Local Institution - 116
  • Florida
    • Fleming Island, Florida, United States, 32003
      • Local Institution - 068
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
    • Ocala, Florida, United States, 34474
      • Local Institution - 054
    • Pensacola, Florida, United States, 32504
      • Local Institution - 114
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Local Institution - 011
    • Newnan, Georgia, United States, 30265
      • Local Institution - 083
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Local Institution - 108
    • Hines, Illinois, United States, 60141
      • United States Department of Veterans Affairs - VA Great Lakes Health Care System - Edward Hines Jr
    • Hinsdale, Illinois, United States, 60521
      • Local Institution - 159
    • Niles, Illinois, United States, 60714
      • Local Institution - 056
    • Park Ridge, Illinois, United States, 60068
      • Local Institution - 028
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research Inc.
  • Indiana
    • New Albany, Indiana, United States, 47150
      • American Health Network of Indiana, LLC
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic
    • Sioux City, Iowa, United States, 51101-1733
      • Siouxland Hematology-Oncology Associates, LLP
    • Waterloo, Iowa, United States, 50701
      • Cedar Valley Medical Specialists
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Local Institution - 019
    • Great Bend, Kansas, United States, 67530
      • Local Institution - 350
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Kentucky Cancer Clinic
    • Louisville, Kentucky, United States, 40207
      • Local Institution - 138
  • Maine
    • Waterville, Maine, United States, 04901
      • Local Institution - 143
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21204
      • Local Institution - 030
    • Rockville, Maryland, United States, 20850
      • Associates Of Oncology/Hematology, P.C.
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Local Institution - 051
    • Lansing, Michigan, United States, 48912
      • Local Institution - 033
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Local Institution - 164
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Local Institution - 050
    • Columbia, Missouri, United States, 65212
      • Local Institution - 103
    • Saint Louis, Missouri, United States, 63110
      • Local Institution - 042
    • Springfield, Missouri, United States, 65804
      • Local Institution - 013
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Local Institution - 003
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Local Institution - 098
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Summit Medical Group Overlook Oncology Center
    • East Orange, New Jersey, United States, 07018
      • Veterans Affairs New Jersey Health Care System
    • Englewood, New Jersey, United States, 07631
      • Local Institution - 080
    • Mount Holly, New Jersey, United States, 08060
      • Local Institution - 025
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
  • New York
    • Brooklyn, New York, United States, 11212
      • Brookdale University Hospital and Medical Center
    • Glens Falls, New York, United States, 12801
      • C.R. Wood Cancer Center at Glens Falls Hospital
    • Johnson City, New York, United States, 13790
      • Broome Oncology, LLC
    • Lake Success, New York, United States, 11042
      • Local Institution - 152
  • North Carolina
    • Kinston, North Carolina, United States, 28501-1584
      • Local Institution - 023
    • Raleigh, North Carolina, United States, 27607
      • Local Institution - 039
  • Ohio
    • Akron, Ohio, United States, 44202
      • Summa Health System Akron City Hospital Laboratory
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Cincinnati, Ohio, United States, 45242
      • Local Institution - 161
    • Cleveland, Ohio, United States, 44109
      • Local Institution - 047
    • Columbus, Ohio, United States, 43219
      • Local Institution - 045
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic Cancer Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Local Institution - 037
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Local Institution - 059
    • Medford, Oregon, United States, 97504
      • Hematology Oncology Associates, P.C.
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Local Institution - 073
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Regional Hospital
    • Sioux Falls, South Dakota, United States, 57105
      • Local Institution - 153
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Baptist Cancer Center
    • Memphis, Tennessee, United States, 38104
      • Local Institution - 076
  • Texas
    • Amarillo, Texas, United States, 79106
      • Local Institution - 166
    • Arlington, Texas, United States, 76014
      • Texas Oncology-Arlington South
    • Arlington, Texas, United States, 76012
      • Arlington Cancer Center
    • Dallas, Texas, United States, 75230
      • Local Institution - 105
    • Houston, Texas, United States, 77030
      • Local Institution - 026
    • Houston, Texas, United States, 77030
      • Local Institution - 067
    • Houston, Texas, United States, 77090
      • Local Institution - 008
    • Plano, Texas, United States, 75093
      • Local Institution - 021
    • Round Rock, Texas, United States, 78681
      • Local Institution - 071
    • San Antonio, Texas, United States, 78217
      • Local Institution - 070
    • San Antonio, Texas, United States, 78240
      • Local Institution - 058
    • Temple, Texas, United States, 66205
      • Local Institution - 111
    • Tyler, Texas, United States, 75702
      • Local Institution - 163
    • Tyler, Texas, United States, 75701
      • Local Institution - 094
    • Webster, Texas, United States, 77598-4420
      • Local Institution - 057
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Local Institution - 090
  • Vermont
    • Rutland, Vermont, United States, 05701
      • Rutland Regional Medical Center
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • Local Institution - 053
    • Fort Belvoir, Virginia, United States, 22060
      • Local Institution - 129
    • Norfolk, Virginia, United States, 23502
      • Local Institution - 081
    • Portsmouth, Virginia, United States, 23704
      • Cancer Treatment Center of America
  • Washington
    • Bellingham, Washington, United States, 98225
      • PeaceHealth St. Joseph Medical Center
    • Gig Harbor, Washington, United States, 98332
      • Local Institution - 049
    • Olympia, Washington, United States, 98502
      • Local Institution - 119
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance
    • Vancouver, Washington, United States, 98684
      • Local Institution - 104
    • Walla Walla, Washington, United States, 99362
      • Local Institution - 099
    • Wenatchee, Washington, United States, 98801
      • Local Institution - 006
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Local Institution - 038
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Aurora Health Care Aurora Research
    • Mukwonago, Wisconsin, United States, 53145
      • Local Institution - 301
    • Oconomowoc, Wisconsin, United States, 53066
      • Local Institution - 300
    • Waukesha, Wisconsin, United States, 53188-5099
      • Local Institution - 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Lenalidomide + rituximab followed by lenalidomide; 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	Drug: Rituximab; Other Names: Rituxan; Drug: Lenalidomide; Other Names: CC-5013, Revlimid
Active Comparator: Arm B: Lenalidomide + rituximab followed by rituximab; 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	Drug: Rituximab; Other Names: Rituxan; Drug: Lenalidomide; Other Names: CC-5013, Revlimid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	Progression free survival (PFS) is defined as the time from the date of first dose of maintenance therapy to the date of the first objective documentation of tumor progression or death due to any cause. Analysis was based on Kaplan Meier estimates. The PFS events were determined using a modification of the IWG 1999 criteria.	From the first dose date of maintenance therapy to objective disease progression or death from any cause, whichever occurs first (up to approximately 432 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall Survival (OS) is defined as the time between the first dose date of maintenance therapy and death from any cause. Participants who complete the study and are still alive at the time of the clinical data cutoff date will be censored at the last visit date or the last contact date, whichever is later. Participants who were lost to follow-up prior to the clinical data cut-off date will also be censored at the time of the last contact. Analysis was based on Kaplan Meier estimates and Hazard Ratio (HR).	From the first dose date of maintenance therapy to death from any cause (up to approximately 480 weeks)
Improvement of Response (IOR)	Improvement of Response (IOR) is the percentage of participants with improved tumor response during the maintenance phase (converted from partial response at end of induction to complete response or complete response unconfirmed as best response) and participants who converted from stable disease at the end of induction period to partial response or better as best response during maintenance phase.	From the first dose date of maintenance therapy to death from any cause (up to approximately 432 weeks)
Overall Response Rate (ORR)	The overall response rate (ORR) is defined as the percentage of participants with a best response of at least partial response (including complete response, complete response unconfirmed and partial response) after the first dose date of maintenance therapy and prior to any treatment change.	From the first dose date of maintenance therapy up to CR, CRu, PR, or treatment change (up to approximately 432 weeks)
Complete Response Rate (CRR)	Best Complete Response Rate (CRR), defined as the proportion of participants with a best response of at least CRu (including CR and CRu) after the first dose date of maintenance therapy and prior to any treatment change.	From the first dose date of maintenance therapy up to CR or CRu (up to approximately 432 weeks)
Duration of Response (DOR)	DOR is from initial response (at least CRu) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death. Participants who have not progressed or died at the time of the clinical data cutoff date will be censored at the last assessment showing no progression. Participants who change treatment without evidence of disease progression will be censored at the last assessment showing no progression prior to treatment change. Analysis was based on Kaplan Meier estimates.	From the initial response (at least PR) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death, whichever occurs first (up to approximately 432 weeks)
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. Participants without new treatment therapy will be censored at the last visit. Analysis was based on Kaplan Meier estimates.	From the first dose date of maintenance therapy to the time of first documented administration of new anti-lymphoma therapy (up to approximately 300 weeks)
Time to Histological Transformation	Time to histological transformation is defined as from the first dose date of maintenance therapy to the time of histological transformation as measured based on documentation of histological transformation (as assessed by the investigator). Analysis was based on Kaplan Meier estimates. In case of clinical suspicion of transformation, including rapid disease progression, unexpected changes in "B" symptoms or rapidly increasing LDH, a biopsy should be performed. In this clinical trial, histological transformation will be considered disease progression. This endpoint will not be calculated for participants randomized with transformed Follicular Lymphoma (tFL).	From the first dose date of maintenance therapy to the time of histological transformation (up to approximately 432 weeks)
Duration of Complete Response (DOCR)	Duration of complete response (DOCR) is calculated as the time from the initial response (CR or CRu) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death. Analysis was based on Kaplan Meier estimates. Participants who have not progressed or died at the time of the clinical data cutoff date will be censored at the last assessment showing no progression. Participants who change treatment without evidence of disease progression will be censored at the last assessment showing no progression prior to treatment change.	From the initial CR/CRu after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death, whichever occurs first (up to approximately 432 weeks)
Participants Experiencing Treatment Emergent Adverse Events (TEAEs)	Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment.	From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)
Participants Experiencing Adverse Events Related to Vital Signs	The number of participants who experienced adverse events related to vital sign measurements	From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)
Participants With Grade 3 or Grade 4 Hematology Parameters	Clinical laboratory values in induction period include any laboratory values that are taken after the first dose date of induction therapy through 28 days after the last dose date of induction therapy or before the first dose date of maintenance therapy, whichever is earlier. Graded according to the NCI CTCAE version 4.03, except for tumor flare reaction, which is accessed using NCI CTCAE version 3.0. Participants with zero maximum grade are excluded.	From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)
Participants With Grade 3 or Grade 4 Serum Chemistry Parameters	Clinical laboratory values in induction period include any laboratory values that are taken after the first dose date of induction therapy through 28 days after the last dose date of therapy. Graded according to the NCI CTCAE version 4.03, except for tumor flare reaction, which is accessed using NCI CTCAE version 3.0. Participants with zero maximum grade are excluded.	From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): May 11, 2024
• Study Completion (Actual): September 17, 2024

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimated): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Lymphoma, Mantle cell Lymphoma, Follicular Lymphoma, Marginal zone Lymphoma, Lenalidomide treatment, rituximab treatment, Non Hodgkins Lymphoma
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide; Rituximab
• Other Study ID Numbers: CC-5013-NHL-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No