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

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ClinicalTrials.gov Identifier: NCT01996865
Recruitment Status : Recruiting
First Posted : November 27, 2013
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Lenalidomide Drug: Rituximab Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3B Randomized Study of Lenalidomide (CC-5013) Plus Rituximab Maintenance Therapy Followed by Lenalidomide Single-Agent Maintenance Versus Rituximab in Subjects With Relapsed/Refractory Follicular, Marginal Zone, or Mantle Cell Lymphoma
Actual Study Start Date : April 2, 2014
Estimated Primary Completion Date : April 8, 2023
Estimated Study Completion Date : July 8, 2024


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 a 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: Lenalidomide
Other Name: CC-5013, Revlimid

Drug: Rituximab
Other Name: Rituxan

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: Lenalidomide
Other Name: CC-5013, Revlimid

Drug: Rituximab
Other Name: Rituxan




Primary Outcome Measures :
  1. Progression free survival (PFS) for Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) [ Time Frame: Up to 8 years ]
    Progression free survival is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 8 years ]
    Number of participants with adverse events

  2. Complete response rate [ Time Frame: 8 years ]
    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)

  3. Overall response rate [ Time Frame: 8 years ]
    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).

  4. Duration of response [ Time Frame: 8 years ]
    Duration of response is defined as the time from the initial response (at least partial remission) to documented disease progression

  5. Duration of complete response [ Time Frame: 8 years ]
    Duration of complete response is defined as the time from the first evidence of CR/CRu to documented disease progression

  6. Time to the next anti-lymphoma treatment [ Time Frame: 8 years ]
    Duration of response is defined as time from initial response of at least a PR to documented progression/relapse

  7. Time to treatment failure [ Time Frame: 8 years ]
    Time to treatment failure is defined as the time from the date of randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death

  8. Time to histological transformation [ Time Frame: 8 years ]
    Time to histological transformation is defined as the time from the date of randomization to time to histological transformation as measured based on documentation of histological transformation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-- Age ≥18 years

  • Histologically confirmed Follicular Lymphoma (Grade 1, 2 or 3a), 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 8 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996865


Contacts
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Contact: Caroline Labe, Clinical Trial Manager 617-710-7065 clabe@celgene.com
Contact: Mary Llorente, Assoc Dir, USMA Lymphoma/CLL mllorente@celgene.com

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Locations
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United States, Arizona
Arizona Oncology Recruiting
Tucson, Arizona, United States, 85710
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Sutter East Bay Hospitals Recruiting
Berkeley, California, United States, 94704
John Muir Health Completed
Concord, California, United States, 94520
Sutter Hematology and Oncology Completed
Sacramento, California, United States, 95816
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Sansum Clinic Recruiting
Santa Barbara, California, United States, 93105
United States, Colorado
Rocky Mountain Cancer Centers, LLP [Boulder-COBO] Recruiting
Boulder, Colorado, United States, 80303
VA Eastern Colorado Recruiting
Denver, Colorado, United States, 80220
Colorado Cancer Research Program Terminated
Denver, Colorado, United States, 80222
VVH Cancer Center Valley View Hospital Recruiting
Glenwood Springs, Colorado, United States, 81601
United States, Connecticut
Praxair Cancer Center Danbury Completed
Danbury, Connecticut, United States, 06810
Whittingham Cancer Center Recruiting
Norwalk, Connecticut, United States, 06851
Hematology Oncology Associates, PC Completed
Stamford, Connecticut, United States, 06902
Yale University School of Medicine Recruiting
Trumbull, Connecticut, United States, 06611
Hematology and Oncology Recruiting
Waterbury, Connecticut, United States, 067014
United States, Florida
Cancer Specialists, LLC dba Cancer Specialists of North Florida Terminated
Fleming Island, Florida, United States, 32003
Florida Cancer Affiliates Recruiting
New Port Richey, Florida, United States, 34655
Sacred Heart Medical Oncology Group Recruiting
Pensacola, Florida, United States, 32504
United States, Georgia
Northwest Georgia Oncology Centers, PC Recruiting
Marietta, Georgia, United States, 30060
Cancer Treatment Centers of America - Southeastern Regional Medical Center Recruiting
Newnan, Georgia, United States, 30265
United States, Illinois
Alexian Brothers Hospital Network Recruiting
Elk Grove Village, Illinois, United States, 60007
United States Department of Veterans Affairs - VA Great Lakes Health Care System - Edward Hines Jr Completed
Hines, Illinois, United States, 60141
AMITA Health Cancer Institute & Outpatient Center Recruiting
Hinsdale, Illinois, United States, 60521
Illinois Cancer Specialists Recruiting
Niles, Illinois, United States, 60714
Oncology Specialists, PC Recruiting
Park Ridge, Illinois, United States, 60068
United States, Indiana
American Health Network of Indiana, LLC Terminated
New Albany, Indiana, United States, 47150
United States, Iowa
Siouxland Hematology-Oncology Associates, LLP Completed
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
University of Kansas Cancer Center Recruiting
Fairway, Kansas, United States, 66205
CentralCare Cancer Center Recruiting
Great Bend, Kansas, United States, 67530
United States, Kentucky
Baptist Healthcare System, Inc. Recruiting
Louisville, Kentucky, United States, 40207
United States, Maine
Maine General Medical Center Completed
Waterville, Maine, United States, 04901
United States, Maryland
Anne Arundel Medical Center Completed
Annapolis, Maryland, United States, 21401
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Associates of Oncology/Hematology, P.C. Completed
Rockville, Maryland, United States, 20850
United States, Michigan
Trinity Health -Michigan, d/b/a Saint Joseph Mercy Health System Recruiting
Ann Arbor, Michigan, United States, 48106
Sparrow Hospital and Health System Recruiting
Lansing, Michigan, United States, 48912
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Central Care Cancer Center Recruiting
Bolivar, Missouri, United States, 65613
University of Missouri Health Care Recruiting
Columbia, Missouri, United States, 65212
Saint Louis University Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
Mercy Medical Research Institute Completed
Springfield, Missouri, United States, 65804
United States, Nebraska
Southeast Nebraska Cancer Center Recruiting
Lincoln, Nebraska, United States, 68510
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Summit Medical Group Overlook Oncology Center Completed
Berkeley Heights, New Jersey, United States, 07922
Veterans Affairs New Jersey Health Care System Completed
East Orange, New Jersey, United States, 07018
Drs. Forte, Schleider, and Attas, P.A. Recruiting
Englewood, New Jersey, United States, 07631
Regional Cancer Care Associates LLC Completed
Mount Holly, New Jersey, United States, 08060
Saint Peter's University Hospital Completed
New Brunswick, New Jersey, United States, 08901
United States, New York
Brookdale University Hospital and Medical Center Completed
Brooklyn, New York, United States, 11212
C.R. Wood Cancer Center at Glens Falls Hospital Completed
Glens Falls, New York, United States, 12801
Broome Oncology, LLC Completed
Johnson City, New York, United States, 13790
Clinical Research Alliance Recruiting
Lake Success, New York, United States, 11042
United States, North Carolina
Kinston Medical Specialists PA Recruiting
Kinston, North Carolina, United States, 28501-1584
Rex Cancer Center Recruiting
Raleigh, North Carolina, United States, 27607
United States, Ohio
Aultman Hospital Completed
Canton, Ohio, United States, 44710
Oncology Hematology Care, Inc. Recruiting
Cincinnati, Ohio, United States, 45242
MetroHealth Medical Systems Recruiting
Cleveland, Ohio, United States, 44109
Mid Ohio Oncology Hematology Inc Recruiting
Columbus, Ohio, United States, 43219
Toledo Clinic Cancer Center Completed
Toledo, Ohio, United States, 43623
United States, Oklahoma
Board of Regents of the University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Willamette Valley Cancer Institute Recruiting
Eugene, Oregon, United States, 97401
Hematology Oncology Associates, P.C. Completed
Medford, Oregon, United States, 97504
United States, South Carolina
Hematology and Oncology Associates of SC, LLC Recruiting
Greenville, South Carolina, United States, 29615
United States, South Dakota
Rapid City Regional Hospital Completed
Rapid City, South Dakota, United States, 57701
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Baptist Cancer Center Terminated
Memphis, Tennessee, United States, 38104
Baptist Cancer Center Recruiting
Memphis, Tennessee, United States, 38104
United States, Texas
Texas Oncology, P.A.-Amarillo Recruiting
Amarillo, Texas, United States, 79106
Arlington Cancer Center Completed
Arlington, Texas, United States, 76012
Texas Oncology-Arlington South Completed
Arlington, Texas, United States, 76014
Texas Oncology Recruiting
Dallas, Texas, United States, 75230
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Michael Debakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Millenium Oncology Recruiting
Houston, Texas, United States, 77090
Texas Health Physicians Group Completed
Plano, Texas, United States, 75093
Texas Oncology Round Rock Cancer Center - Round Rock Recruiting
Round Rock, Texas, United States, 78681
Cancer Care Network of South Texas - SAT & BC Recruiting
San Antonio, Texas, United States, 78217
Cancer Care Centers of South Texas - HOAST Recruiting
San Antonio, Texas, United States, 78240
Central Texas Veterans Health Care System Recruiting
Temple, Texas, United States, 66205
Tyler Hematology and Oncology Completed
Tyler, Texas, United States, 75701
Texas Oncology, P.A. - Tyler Recruiting
Tyler, Texas, United States, 75702
Texas Oncology, P.A. - Deke Slayton Cancer Center Completed
Webster, Texas, United States, 77598-4420
United States, Utah
Utah Cancer Specialist Recruiting
Salt Lake City, Utah, United States, 84106
United States, Vermont
Rutland Regional Medical Center Completed
Rutland, Vermont, United States, 05701
United States, Virginia
Oncology and Hematology Associates of Southwest Virginia, Inc. - Market Street Recruiting
Christiansburg, Virginia, United States, 24073
Fort Belvoir Community Hospital Recruiting
Fort Belvoir, Virginia, United States, 22060
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
United States, Washington
PeaceHealth St. Joseph Medical Center Completed
Bellingham, Washington, United States, 98225
Northwest Medical Specialties PLLC Recruiting
Gig Harbor, Washington, United States, 98332
Vista Oncology, Inc. Recruiting
Olympia, Washington, United States, 98502
Northwest Cancer Specialists, P.C. Recruiting
Vancouver, Washington, United States, 98684
Providence St. Mary Regional Cancer Center Recruiting
Walla Walla, Washington, United States, 99362
Wenatchee Valley Hospital and Clinics Recruiting
Wenatchee, Washington, United States, 98801
United States, West Virginia
West Virginia University, Berkeley Medical Center, Cancer and Infusion Center Recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Aurora Health Care Aurora Research Completed
Milwaukee, Wisconsin, United States, 53233
DN Greenwald Center Recruiting
Mukwonago, Wisconsin, United States, 53145
Oconomowoc Memorial Hospital Recruiting
Oconomowoc, Wisconsin, United States, 53066
Waukesha Memorial Hospital Recruiting
Waukesha, Wisconsin, United States, 53188-5099
Germany
Onkologische Schwerpunktpraxis Kurfurstendamm Recruiting
Berlin, Germany, 10707
Klinikum Bremen-Mitte Recruiting
Bremen, Germany, 28177
Centrum fur Hamatologie und Onkologie Bethanien Recruiting
Frankfurt, Germany, 60389
Praxis Internistischer Onkologie und Hamatologie Frechen Recruiting
Frechen, Germany, 50226
Onkologischisches Ambulanzzentrum Hannover Recruiting
Hannover, Germany, 30171
Gemeinschaftspraxis fur Hamatologie und Onkologie Recruiting
Kassel, Germany, 34119
Gemeinschaftspraxis fur Hamatologie und Onkologie Recruiting
Köln, Germany, 50677
OnkoNet Marburg GmbH Recruiting
Marburg, Germany, 35037
Hamato-Onkologische Uberortliche Gemeinschaftspraxis Pasing und Furstenfeldbruck Recruiting
Munchen, Germany, 81241
Kliniken Maria Hilf GmbH Recruiting
Mönchengladbach, Germany, 41063
Gemeinschaftspraxis für Hämatologie und Onkologie Recruiting
Münster, Germany, 48149
Klinikum Ernst von Bergmann gGmbH Recruiting
Potsdam, Germany, 14467
Hamatologie und Onkologie Recruiting
Ravensberg, Germany, 88212
Hamatologisch-onkologische Schwerpunktpraxis Recruiting
Würzburg, Germany, 97080
Puerto Rico
Auxilio Mutuo Cancer Center Recruiting
San Juan, Puerto Rico, 00919-1227
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Kenneth Foon, VP, Med Affairs Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01996865     History of Changes
Other Study ID Numbers: CC-5013-NHL-008
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

Keywords provided by Celgene:
Lymphoma, Mantle cell Lymphoma, Follicular Lymphoma, Marginal zone Lymphoma, Lenalidomide treatment, rituximab treatment, Non Hodgkins Lymphoma

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors