NCT01996865CompletedPhase 3
Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
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
Source: ClinicalTrials.gov · Last updated 10 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 503 (actual)
- First submitted
- 22 Nov 2013
- Start date
- 1 Apr 2014
- Primary completion date
- 11 May 2024
- Lead sponsor
- Celgene
- Diseases
- Follicular lymphoma, Mantle cell lymphoma
- NCT number
- NCT01996865
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 503
- From 1 Apr 2014 to the primary completion date, 11 May 2024
- 126 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any medical condition (other than the underlying lymphoma) that requires chronic steroid use
- 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
Other
- Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma
Who the study is looking for
- \-- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (126)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 208 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Local Institution - 202 Coordinator of this site? Confirm its status | Bremen | Germany | Unknown status |
| Local Institution - 213 Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Local Institution - 205 Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Local Institution - 211 Coordinator of this site? Confirm its status | Frechen | Germany | Unknown status |
| Local Institution - 200 Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Local Institution - 203 Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Local Institution - 206 Coordinator of this site? Confirm its status | Kassel | Germany | Unknown status |
| Local Institution - 210 Coordinator of this site? Confirm its status | Marburg | Germany | Unknown status |
| Local Institution - 215 Coordinator of this site? Confirm its status | Mönchengladbach | Germany | Unknown status |
| Local Institution - 204 Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Local Institution - 212 Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Local Institution - 201 Coordinator of this site? Confirm its status | Potsdam | Germany | Unknown status |
| Local Institution - 207 Coordinator of this site? Confirm its status | Ravensberg | Germany | Unknown status |
| Local Institution - 209 Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Local Institution - 029 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Summa Health System Akron City Hospital Laboratory Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Local Institution - 166 Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| McFarland Clinic Coordinator of this site? Confirm its status | Ames | United States | Unknown status |
| Anne Arundel Medical Center Coordinator of this site? Confirm its status | Annapolis | United States | Unknown status |
| Local Institution - 051 Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Arlington Cancer Center Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Texas Oncology-Arlington South Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Local Institution - 030 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| PeaceHealth St. Joseph Medical Center Coordinator of this site? Confirm its status | Bellingham | United States | Unknown status |
| Local Institution - 079 Coordinator of this site? Confirm its status | Berkeley | United States | Unknown status |
| Summit Medical Group Overlook Oncology Center Coordinator of this site? Confirm its status | Berkeley Heights | United States | Unknown status |
| Local Institution - 050 Coordinator of this site? Confirm its status | Bolivar | United States | Unknown status |
| Local Institution - 052 Coordinator of this site? Confirm its status | Boulder | United States | Unknown status |
| Brookdale University Hospital and Medical Center Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Aultman Hospital Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Local Institution - 053 Coordinator of this site? Confirm its status | Christiansburg | United States | Unknown status |
| Local Institution - 161 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Local Institution - 047 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 103 Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Local Institution - 045 Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Local Institution - 142 Coordinator of this site? Confirm its status | Concord | United States | Unknown status |
| Local Institution - 105 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Praxair Cancer Center Danbury Coordinator of this site? Confirm its status | Danbury | United States | Unknown status |
| Colorado Cancer Research Program Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Local Institution - 106 Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Veterans Affairs New Jersey Health Care System Coordinator of this site? Confirm its status | East Orange | United States | Unknown status |
| Local Institution - 108 Coordinator of this site? Confirm its status | Elk Grove Village | United States | Unknown status |
| Local Institution - 080 Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| Local Institution - 059 Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Local Institution - 019 Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| Local Institution - 068 Coordinator of this site? Confirm its status | Fleming Island | United States | Unknown status |
| Local Institution - 129 Coordinator of this site? Confirm its status | Fort Belvoir | United States | Unknown status |
| Local Institution - 049 Coordinator of this site? Confirm its status | Gig Harbor | United States | Unknown status |
| C.R. Wood Cancer Center at Glens Falls Hospital Coordinator of this site? Confirm its status | Glens Falls | United States | Unknown status |
| Local Institution - 062 Coordinator of this site? Confirm its status | Glenwood Springs | United States | Unknown status |
| Local Institution - 350 Coordinator of this site? Confirm its status | Great Bend | United States | Unknown status |
| Local Institution - 073 Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Kentucky Cancer Clinic Coordinator of this site? Confirm its status | Hazard | United States | Unknown status |
| United States Department of Veterans Affairs - VA Great Lakes Health Care System - Edward Hines Jr Coordinator of this site? Confirm its status | Hines | United States | Unknown status |
| Local Institution - 159 Coordinator of this site? Confirm its status | Hinsdale | United States | Unknown status |
| Local Institution - 026 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Local Institution - 067 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Local Institution - 008 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Broome Oncology, LLC Coordinator of this site? Confirm its status | Johnson City | United States | Unknown status |
| Local Institution - 023 Coordinator of this site? Confirm its status | Kinston | United States | Unknown status |
| Local Institution - 152 Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Local Institution - 033 Coordinator of this site? Confirm its status | Lansing | United States | Unknown status |
| Local Institution - 098 Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| Local Institution - 003 Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| Local Institution - 077 Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Local Institution - 138 Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Medical Oncology and Blood Disorders, LLP Coordinator of this site? Confirm its status | Manchester | United States | Unknown status |
| Local Institution - 011 Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Hematology Oncology Associates, P.C. Coordinator of this site? Confirm its status | Medford | United States | Unknown status |
| Baptist Cancer Center Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Local Institution - 076 Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Mount Sinai Comprehensive Cancer Center Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Aurora Health Care Aurora Research Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Local Institution - 038 Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Local Institution - 025 Coordinator of this site? Confirm its status | Mount Holly | United States | Unknown status |
| Local Institution - 301 Coordinator of this site? Confirm its status | Mukwonago | United States | Unknown status |
| American Health Network of Indiana, LLC Coordinator of this site? Confirm its status | New Albany | United States | Unknown status |
| Saint Peter's University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Local Institution - 083 Coordinator of this site? Confirm its status | Newnan | United States | Unknown status |
| Local Institution - 056 Coordinator of this site? Confirm its status | Niles | United States | Unknown status |
| Local Institution - 081 Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Local Institution - 041 Coordinator of this site? Confirm its status | Norwalk | United States | Unknown status |
| Local Institution - 054 Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Local Institution - 300 Coordinator of this site? Confirm its status | Oconomowoc | United States | Unknown status |
| Local Institution - 037 Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Local Institution - 119 Coordinator of this site? Confirm its status | Olympia | United States | Unknown status |
| Local Institution - 028 Coordinator of this site? Confirm its status | Park Ridge | United States | Unknown status |
| Local Institution - 114 Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Local Institution - 021 Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Bay Area Cancer Research Group, LLC Coordinator of this site? Confirm its status | Pleasant Hill | United States | Unknown status |
| Cancer Treatment Center of America Coordinator of this site? Confirm its status | Portsmouth | United States | Unknown status |
| Local Institution - 039 Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Rapid City Regional Hospital Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Local Institution - 164 Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Associates Of Oncology/Hematology, P.C. Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Local Institution - 071 Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Rutland Regional Medical Center Coordinator of this site? Confirm its status | Rutland | United States | Unknown status |
| Sutter Hematology and Oncology Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Local Institution - 090 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Local Institution - 070 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Local Institution - 058 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Local Institution - 032 Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Local Institution - 130 Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| Seattle Cancer Care Alliance Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Siouxland Hematology - Oncology Associates, LLP Coordinator of this site? Confirm its status | Sioux City | United States | Unknown status |
| Local Institution - 153 Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Orchard Healthcare Research Inc. Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| Local Institution - 013 Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Hematology Oncology Associates, PC Coordinator of this site? Confirm its status | Stamford | United States | Unknown status |
| Local Institution - 042 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Local Institution - 111 Coordinator of this site? Confirm its status | Temple | United States | Unknown status |
| Toledo Clinic Cancer Center Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Local Institution - 149 Coordinator of this site? Confirm its status | Trumbull | United States | Unknown status |
| Local Institution - 055 Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Local Institution - 094 Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| Local Institution - 163 Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| Local Institution - 104 Coordinator of this site? Confirm its status | Vancouver | United States | Unknown status |
| Local Institution - 099 Coordinator of this site? Confirm its status | Walla Walla | United States | Unknown status |
| Local Institution - 116 Coordinator of this site? Confirm its status | Waterbury | United States | Unknown status |
| Cedar Valley Medical Specialists Coordinator of this site? Confirm its status | Waterloo | United States | Unknown status |
| Local Institution - 143 Coordinator of this site? Confirm its status | Waterville | United States | Unknown status |
| Local Institution - 101 Coordinator of this site? Confirm its status | Waukesha | United States | Unknown status |
| Local Institution - 057 Coordinator of this site? Confirm its status | Webster | United States | Unknown status |
| Local Institution - 006 Coordinator of this site? Confirm its status | Wenatchee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.