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Lymphoma, Non-HodgkinPhase 3MAGNIFYNCT01996865

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

A Phase 3 study testing Lenalidomide and Rituximab in people with Lymphoma, Non-Hodgkin, run by Celgene at 126 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
Lenalidomide and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
503 participants
Where
126 sitesin 3 countries
Study dates
1 Apr 2014to 17 Sep 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -- 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

126 sites in 3 countries.

126 sites in 3 countries

United States110 sites

  • Summa Health System Akron City Hospital Laboratory

    Akron, Ohio, 44202

  • Local Institution - 166

    Amarillo, Texas, 79106

  • McFarland Clinic

    Ames, Iowa, 50010

  • Local Institution - 051

    Ann Arbor, Michigan, 48106

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Texas Oncology-Arlington South

    Arlington, Texas, 76014

  • Local Institution - 030

    Baltimore, Maryland, 21204

  • PeaceHealth St. Joseph Medical Center

    Bellingham, Washington, 98225

  • Local Institution - 079

    Berkeley, California, 94704

  • Summit Medical Group Overlook Oncology Center

    Berkeley Heights, New Jersey, 07922

  • Local Institution - 050

    Bolivar, Missouri, 65613

  • Local Institution - 052

    Boulder, Colorado, 80303

  • Brookdale University Hospital and Medical Center

    Brooklyn, New York, 11212

  • Aultman Hospital

    Canton, Ohio, 44710

  • Local Institution - 053

    Christiansburg, Virginia, 24073

  • Local Institution - 161

    Cincinnati, Ohio, 45242

  • Local Institution - 047

    Cleveland, Ohio, 44109

  • Local Institution - 103

    Columbia, Missouri, 65212

  • Local Institution - 045

    Columbus, Ohio, 43219

  • Local Institution - 142

    Concord, California, 94520

  • Local Institution - 105

    Dallas, Texas, 75230

  • Praxair Cancer Center Danbury

    Danbury, Connecticut, 06810

  • Local Institution - 106

    Denver, Colorado, 80220

  • Colorado Cancer Research Program

    Denver, Colorado, 80222

  • Veterans Affairs New Jersey Health Care System

    East Orange, New Jersey, 07018

  • Local Institution - 108

    Elk Grove Village, Illinois, 60007

  • Local Institution - 080

    Englewood, New Jersey, 07631

  • Local Institution - 059

    Eugene, Oregon, 97401

  • Local Institution - 019

    Fairway, Kansas, 66205

  • Local Institution - 068

    Fleming Island, Florida, 32003

  • Local Institution - 129

    Fort Belvoir, Virginia, 22060

  • Local Institution - 049

    Gig Harbor, Washington, 98332

  • C.R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Local Institution - 062

    Glenwood Springs, Colorado, 81601

  • Local Institution - 350

    Great Bend, Kansas, 67530

  • Local Institution - 073

    Greenville, South Carolina, 29615

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • United States Department of Veterans Affairs - VA Great Lakes Health Care System - Edward Hines Jr

    Hines, Illinois, 60141

  • Local Institution - 159

    Hinsdale, Illinois, 60521

  • Local Institution - 026

    Houston, Texas, 77030

  • Local Institution - 067

    Houston, Texas, 77030

  • Local Institution - 008

    Houston, Texas, 77090

  • Broome Oncology, LLC

    Johnson City, New York, 13790

  • Local Institution - 023

    Kinston, North Carolina, 28501-1584

  • Local Institution - 152

    Lake Success, New York, 11042

  • Local Institution - 033

    Lansing, Michigan, 48912

  • Local Institution - 098

    Lebanon, New Hampshire, 03756

  • Local Institution - 003

    Lincoln, Nebraska, 68510

  • Local Institution - 077

    Little Rock, Arkansas, 72205

  • Local Institution - 138

    Louisville, Kentucky, 40207

  • Medical Oncology and Blood Disorders, LLP

    Manchester, Connecticut, 06040

  • Local Institution - 011

    Marietta, Georgia, 30060

  • Hematology Oncology Associates, P.C.

    Medford, Oregon, 97504

  • Baptist Cancer Center

    Memphis, Tennessee, 38104

  • Local Institution - 076

    Memphis, Tennessee, 38104

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Aurora Health Care Aurora Research

    Milwaukee, Wisconsin, 53233

  • Local Institution - 038

    Morgantown, West Virginia, 26506

  • Local Institution - 025

    Mount Holly, New Jersey, 08060

  • Local Institution - 301

    Mukwonago, Wisconsin, 53145

  • American Health Network of Indiana, LLC

    New Albany, Indiana, 47150

  • Saint Peter'S University Hospital

    New Brunswick, New Jersey, 08901

  • Local Institution - 083

    Newnan, Georgia, 30265

  • Local Institution - 056

    Niles, Illinois, 60714

  • Local Institution - 081

    Norfolk, Virginia, 23502

  • Local Institution - 041

    Norwalk, Connecticut, 06851

  • Local Institution - 054

    Ocala, Florida, 34474

  • Local Institution - 300

    Oconomowoc, Wisconsin, 53066

  • Local Institution - 037

    Oklahoma City, Oklahoma, 73104

  • Local Institution - 119

    Olympia, Washington, 98502

  • Local Institution - 028

    Park Ridge, Illinois, 60068

  • Local Institution - 114

    Pensacola, Florida, 32504

  • Local Institution - 021

    Plano, Texas, 75093

  • Bay Area Cancer Research Group, LLC

    Pleasant Hill, California, 94523

  • Cancer Treatment Center of America

    Portsmouth, Virginia, 23704

  • Local Institution - 039

    Raleigh, North Carolina, 27607

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Local Institution - 164

    Rochester, Minnesota, 55905

  • Associates Of Oncology/Hematology, P.C.

    Rockville, Maryland, 20850

  • Local Institution - 071

    Round Rock, Texas, 78681

  • Rutland Regional Medical Center

    Rutland, Vermont, 05701

  • Sutter Hematology and Oncology

    Sacramento, California, 95816

  • Local Institution - 090

    Salt Lake City, Utah, 84106

  • Local Institution - 070

    San Antonio, Texas, 78217

  • Local Institution - 058

    San Antonio, Texas, 78240

  • Local Institution - 032

    San Diego, California, 92123

  • Local Institution - 130

    Santa Barbara, California, 93105

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101-1733

  • Local Institution - 153

    Sioux Falls, South Dakota, 57105

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077

  • Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute

    Spartanburg, South Carolina, 29303

  • Local Institution - 013

    Springfield, Missouri, 65804

  • Local Institution - 042

    St Louis, Missouri, 63110

  • Hematology Oncology Associates, PC

    Stamford, Connecticut, 06902

  • Local Institution - 111

    Temple, Texas, 66205

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

  • Local Institution - 149

    Trumbull, Connecticut, 06611

  • Local Institution - 055

    Tucson, Arizona, 85710

  • Local Institution - 094

    Tyler, Texas, 75701

  • Local Institution - 163

    Tyler, Texas, 75702

  • Local Institution - 104

    Vancouver, Washington, 98684

  • Local Institution - 099

    Walla Walla, Washington, 99362

  • Local Institution - 116

    Waterbury, Connecticut, 067014

  • Cedar Valley Medical Specialists

    Waterloo, Iowa, 50701

  • Local Institution - 143

    Waterville, Maine, 04901

  • Local Institution - 101

    Waukesha, Wisconsin, 53188-5099

  • Local Institution - 057

    Webster, Texas, 77598-4420

  • Local Institution - 006

    Wenatchee, Washington, 98801

Other trials in United States

Germany15 sites

  • Local Institution - 208

    Berlin, 10707

  • Local Institution - 202

    Bremen, 28177

  • Local Institution - 213

    Cologne, 50677

  • Local Institution - 205

    Frankfurt, 60389

  • Local Institution - 211

    Frechen, 50226

  • Local Institution - 200

    Giessen, 35392

  • Local Institution - 203

    Hanover, 30171

  • Local Institution - 206

    Kassel, 34119

  • Local Institution - 210

    Marburg, 35037

  • Local Institution - 215

    Mönchengladbach, 41063

  • Local Institution - 204

    München, 81241

  • Local Institution - 212

    Münster, 48149

  • Local Institution - 201

    Potsdam, 14467

  • Local Institution - 207

    Ravensberg, 88212

  • Local Institution - 209

    Würzburg, 97080

Other trials in Germany

Puerto Rico1 site

  • Local Institution - 029

    San Juan, 00919-1227

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Being tested
Lenalidomide, Rituximab
Keywords
Lymphoma, Mantle cell Lymphoma, Follicular Lymphoma, Marginal zone Lymphoma, Lenalidomide treatment, rituximab treatment, Non Hodgkins Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01996865
Study groupRoleWhat they receive
Arm A: Lenalidomide + rituximab followed by lenalidomideExperimentalInduction 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
Receives: Drug: Lenalidomide; Drug: Rituximab
Arm B: Lenalidomide + rituximab followed by rituximabActive comparatorInduction 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
Receives: Drug: Lenalidomide; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (12)

  1. 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).

    Measured: From the first dose date of maintenance therapy to death from any cause (up to approximately 480 weeks)

  2. 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.

    Measured: From the first dose date of maintenance therapy to death from any cause (up to approximately 432 weeks)

  3. 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.

    Measured: From the first dose date of maintenance therapy up to CR, CRu, PR, or treatment change (up to approximately 432 weeks)

  4. 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.

    Measured: From the first dose date of maintenance therapy up to CR or CRu (up to approximately 432 weeks)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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).

    Measured: From the first dose date of maintenance therapy to the time of histological transformation (up to approximately 432 weeks)

  8. 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.

    Measured: 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)

  9. 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.

    Measured: From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

  10. Participants Experiencing Adverse Events Related to Vital Signs

    The number of participants who experienced adverse events related to vital sign measurements

    Measured: From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

  11. 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.

    Measured: From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

  12. 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.

    Measured: From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2013 (estimated)
  2. Study start1 Apr 2014
  3. Primary completion11 May 2024
  4. Study completion17 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01996865
Sponsor's protocol ID
CC-5013-NHL-008
Acronym
MAGNIFY
Status last verified
Jul 2025
First submitted
22 Nov 2013
Last updated
10 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 30897038

  • 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.

    PubMed 30919940

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide and Rituximab in people with Lymphoma, Non-Hodgkin, run by Celgene at 126 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in United States, Germany, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01996865, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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