Non Hodgkin Lymphoma Clinical Trial
Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
Summary
To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.
Full Description
This research study is for patients with newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) of the activated B-cell (ABC) type who have not yet been treated. DLBCL is a cancer of a type of blood cell called B-lymphocytes. B lymphocytes are part of the body's immune system. There are different types of DLBCL. About a third of newly diagnosed DLBCL cancers are the ABC type. It has been observed that treatment does not work as well for patients with the ABC type compared to patients with other DLBCL types who receive standard treatment. However, at this time both ABC type and other DLBCL type patients receive the same standard treatments.
Patients with DLBCL who are otherwise healthy are usually treated first with the chemotherapy drug combination called R-CHOP. The drugs in this combination are "R" for rituximab, "C" for cyclophosphamide, "H" for doxorubicin which has a chemical name of hydroxydaunomycin, "O" for vincristine which has a trade name of oncovin, and "P" for prednisone. Depending on the local practice where you are treated, R-CHOP may be given for 6 or 8 cycles. A cycle could lasts for 14 or 21 days. The R-CHOP drug combination is approved for the treatment of DLBCL of all types, including ABC type. R-CHOP is standard care.
This study will test the standard R-CHOP21 against R-CHOP21 plus lenalidomide. The purpose is to see whether adding lenalidomide works better and is as safe as R-CHOP by itself. This study is only for patients with ABC type DLBCL who have not yet been treated. Lenalidomide is not approved for use in DLBCL. Its use in this disease is experimental. In this study, the experimental treatment is lenalidomide + R-CHOP21 x 6.
This study will use a gene expression profile (GEP) test to see if a patient has the ABC type. The results of this GEP test affect whether you may be treated on this study. Because the performance of this test has not been proven, it is for investigational use only, and is still under development. This means the GEP test is an experimental test.
Eligibility Criteria
Inclusion Criteria:
Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type
Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma
Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) / Magnetic Resonance Imagining (MRI) scans
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
Age 18 - 80 years; age > 80 allowed at investigator discretion if performance status ≤ 1; and each organ system score ≤ 2 using cumulative illness rating scale (CIRS)
Exclusion Criteria:
Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma
History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient has been disease free for 5 years or more
Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF (Left Ventricular Ejection Fraction) < 45% or peripheral neuropathy grade 2
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There are 158 Locations for this study
Fayetteville Arkansas, 72703, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
New Haven Connecticut, 06510, United States
Hollywood Florida, 33021, United States
Ames Iowa, 50010, United States
Sioux City Iowa, 51101, United States
Fairway Kansas, 66205, United States
Shreveport Louisiana, 71103, United States
Bethesda Maryland, 20817, United States
Minneapolis Minnesota, 55416, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Durham North Carolina, 27710, United States
Philadelphia Pennsylvania, 19111, United States
Dallas Texas, 75235, United States
Dallas Texas, 75390, United States
Salt Lake City Utah, 84106, United States
Edmonds Washington, 98026, United States
Issaquah Washington, 98029, United States
Seattle Washington, 98104, United States
Seattle Washington, 98107, United States
Albury New South Wales, 2640, Australia
Clayton Victoria, 3168, Australia
Geelong Victoria, 3220, Australia
Frankston , 3199, Australia
Brussels , 1200, Belgium
Liege , 4000, Belgium
Roeselare , 8800, Belgium
Sint-Niklaas , 9100, Belgium
Calgary Alberta, T2N 4, Canada
Surrey British Columbia, V3T 0, Canada
Saint John New Brunswick, E2L 3, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H1T 2, Canada
Beijing , 10004, China
Beijing , 10014, China
Beijing , 10019, China
Beijing , 10073, China
Changchun , 13002, China
Chengdu , 61004, China
Chongqing , 40003, China
Fuzhou , 35000, China
Guangzhou, Guangdong , 51008, China
Hangzhou , 31000, China
Harbin, Heilongjiang , 15008, China
Nanjing, Jiangsu , 21000, China
Nanjing , 21002, China
Shanghai , 20003, China
Suzhu , 21500, China
Tianjin , 30006, China
Wuhan , 43003, China
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 775 2, Czechia
Prague 10 , 100 3, Czechia
Praha , 128 0, Czechia
Bayonne , 64109, France
Bordeaux , 33076, France
Montpellier , 34295, France
Paris , 75010, France
Pessac Cedex , 33604, France
Toulose , 31059, France
Vandoeuvre les Nancy , 54511, France
Dublin 4 , 4, Ireland
Galway , ST46Q, Ireland
Beer-Sheva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Kfar-Saba , 44281, Israel
Petach Tikva , 49100, Israel
Tel-Aviv , 64239, Israel
Zerifin , 70300, Israel
Terni Umbria, 05100, Italy
Allessandria , 15100, Italy
Brescia , 25123, Italy
Cuneo , 12100, Italy
Firenze , 50134, Italy
Genova , 16132, Italy
Ivrea , 10015, Italy
Meldola , 47014, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Milano , 20162, Italy
Napoli, Campania , 80131, Italy
Novara , 28100, Italy
Padova , 35128, Italy
Pagani , 84016, Italy
Pavia , 27100, Italy
Ravenna , 48121, Italy
Reggio Emilia , 42100, Italy
Rimini , 47900, Italy
Roma , 00128, Italy
Roma , 00161, Italy
Roma , 00189, Italy
Rome , 00152, Italy
Torino , 01012, Italy
Torino , 10126, Italy
Tricase , 73039, Italy
Udine , 33100, Italy
Verona , 37134, Italy
Vicenza , 36100, Italy
Chuo-ku Tokyo, 104-0, Japan
Koto-ku Tokyo, 13585, Japan
Minato-ku Tokyo, 105-8, Japan
Akita-shi , 010-8, Japan
Fukuoka , 812-8, Japan
Isehara City, Kanagawa , 259-1, Japan
Kashiwa , 277-8, Japan
Kyoto-City , 602-8, Japan
Minami-Ku, Fukuoka , 811-1, Japan
Nagoya , 464-8, Japan
Sendai-city , 983-8, Japan
Yamagata , 990-9, Japan
Gyeonggi-do , 410-7, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Amsterdam , 1081 , Netherlands
Breda , 4818 , Netherlands
Hoofddorp , 2135, Netherlands
Leeuwarden , 8934 , Netherlands
s-Hertogenbosch , 5223 , Netherlands
Schiedam , 3118 , Netherlands
Christchurch , 8011, New Zealand
Palmerston , 4414, New Zealand
Figueira da Foz , 3094-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1400-, Portugal
Pragal , 2801-, Portugal
San Juan , 00918, Puerto Rico
Kazan , 42002, Russian Federation
Moscow , 11547, Russian Federation
St. Petersburg , 19775, Russian Federation
Barcelona , 08025, Spain
Barcelona , 08916, Spain
Caceres , 10003, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Sevilla , 41014, Spain
Valencia , 46010, Spain
Valencia , 46026, Spain
Bellinzona , 6500, Switzerland
Geneva , 1211, Switzerland
Winterthur , 8400, Switzerland
Niao-Sung Hsiang Kaohsiung County , 83301, Taiwan
Taichung City , 40447, Taiwan
Taipei, Zhongzheng Dist. , 10002, Taiwan
Adana , 01330, Turkey
Ankara , 06590, Turkey
Antalya , 07058, Turkey
Denizli , 20070, Turkey
Edirne , 22030, Turkey
Istanbul , 34093, Turkey
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