Non Hodgkin Lymphoma Clinical Trial
Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin’s Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
Summary
This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.
Full Description
Indolent lymphoma is a slow growing but incurable lymphoma which includes follicular lymphoma and marginal zone lymphoma. Follicular lymphoma and marginal zone lymphoma are cancers of the B lymphocyte, a type of white blood cell. Lenalidomide is an immunomodulatory drug (a drug that affects the immune system) which alters the body's immune system and it may also interfere with the development of tiny blood vessels involved in tumor growth. Therefore, lenalidomide may reduce or prevent the growth of cancer cells. Lenalidomide has also been shown to restore the immune cells' ability to attack and kill tumor cells, an ability that may be inhibited by follicular lymphoma and other lymphomas. The combination of rituximab and lenalidomide may eliminate the cancer while restoring the immune system's ability to attack tumor cells.
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years at the time of signing the informed consent document.
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a; CD20+ by flow cytometry or histochemistry).
Previously treated with at least one prior systemic chemotherapy, immunotherapy or chemoimmunotherapy and have received at least 2 previous doses of rituximab.
Documented relapsed, refractory or progressive disease after treatment with systemic therapy and must not be rituximab-refractory.
Investigator considers rituximab monotherapy appropriate.
Bi-dimensionally measurable disease on cross sectional imaging by X-ray computed tomography (CT) or magnetic resonance imaging (MRI).
Need of treatment for relapsed, progressed or refractory disease as assessed by the investigator.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Adequate bone marrow function.
Willingness to follow study visit schedule, pregnancy precautions and other protocol requirements.
Exclusion Criteria:
Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma.
Subjects taking corticosteroids during the last week prior to study treatment, unless administered at a dose equivalent to < 20 mg/day prednisone or prednisolone.
Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 6 months.
Known seropositive for or active viral infection with hepatitis B virus (HBV) or/and human immunodeficiency virus (HIV).
Known hepatitis C virus (HCV) positive with chronic HCV or active viral infection with HCV hepatitis requiring anti-viral medication (at time of randomization).
Life expectancy < 6 months.
Known sensitivity or allergy to murine products.
Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years.
Prior use of lenalidomide.
Known allergy to thalidomide.
Neuropathy > Grade 1.
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.
Uncontrolled intercurrent illness.
Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.
Pregnant or lactating females.
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.
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There are 140 Locations for this study
Mobile Alabama, 36604, United States
Glendale Arizona, 85306, United States
Escondido California, 92025, United States
Greenbrae California, 94904, United States
La Verne California, 91750, United States
Oceanside California, 92056, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
Santa Maria California, 93454, United States
West Hills California, 92056, United States
Southington Connecticut, 06489, United States
Saint Petersburg Florida, 33705, United States
Peoria Illinois, 61615, United States
Laconia Indiana, 03246, United States
Des Moines Iowa, 50309, United States
Louisville Kentucky, 40202, United States
Southfield Michigan, 48075, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Hooksett New Hampshire, 03106, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07962, United States
Albuquerque New Mexico, 87102, United States
New York New York, 10065, United States
Syracuse New York, 13210, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45242, United States
Portland Oregon, 97213, United States
Portland Oregon, 97213, United States
Greenville South Carolina, 29607, United States
Spartanburg South Carolina, 29303, United States
Nashville Tennessee, 37203, United States
Arlington Texas, 76012, United States
Houston Texas, 77030, United States
Tacoma Washington, 98405, United States
Brugge , 8000, Belgium
Gent , 9000, Belgium
Gent , 9000, Belgium
Kortrijk , 8500, Belgium
Yvoir , 5530, Belgium
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Porto Alegre Rio Grande Do Sul, 90740, Brazil
Barretos São Paulo, 14784, Brazil
Jau/SP São Paulo, 17210, Brazil
Rio De Janeiro , 20231, Brazil
São Paulo , 01308, Brazil
São Paulo , 01321, Brazil
São Paulo , 01509, Brazil
Beijing, PR , 10014, China
Beijing , 10004, China
Beijing , 10007, China
Beijing , 10073, China
Changsha , 41001, China
Chengdu , 61004, China
Fuzhou , 35000, China
Guangzhou , 51006, China
Guangzhou , 51008, China
Guangzhou , 51008, China
Hangzhou City , 31000, China
Hangzhou City , 31000, China
Nanjing , 21002, China
Shanghai , 20003, China
Shanghai , , China
Suzhou , 21500, China
Tianjin , 30002, China
Tianjin , 30006, China
Xi'an , 71003, China
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Ostrava , 70852, Czechia
Prague 10 , 100 3, Czechia
Praha , 128 0, Czechia
Praha , 128 0, Czechia
Angers , 49033, France
Bobigny Cedex , 93009, France
Brest Cedex , 29609, France
Paris , 75010, France
Perpignan , 66046, France
Poitiers , 86021, France
Valence , 26953, France
Berlin , 12203, Germany
Berlin , 13353, Germany
Frankfurt , 60488, Germany
Leer , 26789, Germany
Mönchengladbach , 41063, Germany
Villingen-Schwenningen , 78052, Germany
Beer Sheva , 84101, Israel
Jerusalem , 91120, Israel
Tel-Aviv , 64239, Israel
Aviano (PN) , 33081, Italy
Barletta , 76121, Italy
Bologna , 40138, Italy
Catania , 95124, Italy
Meldola , 47014, Italy
Milano , 20141, Italy
Milano , 20162, Italy
Napoli , 80131, Italy
Palermo , 90146, Italy
Palermo , 90146, Italy
Parma , 43100, Italy
Ravenna , 48121, Italy
Reggio Calabria , 89100, Italy
Rimini , 47900, Italy
Roma , 00189, Italy
Roma , 00189, Italy
Nagasaki-shi Nagasaki, 852-8, Japan
Minato-ku Tokyo, 105-8, Japan
Chuo-ku , 104-0, Japan
Hiroshima , 72000, Japan
Kashiwa , 277-8, Japan
Kobe-city , 650-0, Japan
Koto-ku , 135-8, Japan
Koto-ku , 13500, Japan
Kyoto-city , 602-8, Japan
Minato-ku , 105-8, Japan
Nagasaki , 852-8, Japan
Nagoya , 460-0, Japan
Sendai-shi , 980-8, Japan
Kraków , 30-51, Poland
Warszawa , 02-77, Poland
Warszawa , 02-77, Poland
Warszawa , 02-78, Poland
Warszawa , 02-78, Poland
Lisboa , 1099-, Portugal
Lisboa , 1099-, Portugal
Porto , 4200-, Portugal
Porto , 4200-, Portugal
San Juan , 00918, Puerto Rico
Krasnoyarsk , 66002, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 12510, Russian Federation
St Petersburg , 19734, Russian Federation
St.Petersburg , 19702, Russian Federation
Tula , 30005, Russian Federation
Barcelona , 08041, Spain
Córdoba , 14004, Spain
Córdoba , 14004, Spain
Madrid , 28031, Spain
Madrid , 28040, Spain
Marbella , 29603, Spain
Marbella , 29603, Spain
Murcia , 30008, Spain
Murcia , 30008, Spain
Salamanca , 37007, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Adana , 01330, Turkey
Ankara , 06100, Turkey
Denizli , 20070, Turkey
Gaziantep , 27310, Turkey
Istanbul , 34840, Turkey
Izmir , 35340, Turkey
Samsun , 55139, Turkey
Umuttepe Kocaeli , 41380, Turkey
Eastbourne , BN21 , United Kingdom
Liverpool , L7 8X, United Kingdom
London , EC1M , United Kingdom
Westcliff on Sea , SS0 0, United Kingdom
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