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
NCT ID: NCT02285062
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
570 participants
INTERVENTIONAL
2015-02-17
2022-07-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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R2-CHOP
Lenalidomide plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
lenalidomide
Rituximab
Cyclophosphamide
Doxorubicin
prednisone
vincristine
R-CHOP
Placebo plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
Placebo
Rituximab
Cyclophosphamide
Doxorubicin
prednisone
vincristine
Interventions
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lenalidomide
Placebo
Rituximab
Cyclophosphamide
Doxorubicin
prednisone
vincristine
Eligibility Criteria
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Inclusion Criteria
2. Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma
3. Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) / Magnetic Resonance Imagining (MRI) scans
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
5. 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
2. History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient has been disease free for 5 years or more
3. Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
4. Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF (Left Ventricular Ejection Fraction) \< 45% or peripheral neuropathy grade 2
18 Years
80 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 177
Fayetteville, Arkansas, United States
Local Institution - 136
Orange, California, United States
Local Institution - 127
Sacramento, California, United States
Local Institution - 169
New Haven, Connecticut, United States
Local Institution - 128
Hollywood, Florida, United States
McFarland Clinic
Ames, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Local Institution - 143
Fairway, Kansas, United States
Local Institution - 158
Shreveport, Louisiana, United States
Center For Cancer And Blood Disorders
Bethesda, Maryland, United States
Local Institution - 101
Minneapolis, Minnesota, United States
Local Institution - 138
Minneapolis, Minnesota, United States
Local Institution - 112
Rochester, Minnesota, United States
Local Institution - 103
Durham, North Carolina, United States
Local Institution - 161
Philadelphia, Pennsylvania, United States
Local Institution - 951
Dallas, Texas, United States
Local Institution - 151
Dallas, Texas, United States
Local Institution - 146
Salt Lake City, Utah, United States
Local Institution - 905
Edmonds, Washington, United States
Local Institution - 903
Issaquah, Washington, United States
Local Institution - 162
Seattle, Washington, United States
Local Institution - 904
Seattle, Washington, United States
Local Institution - 004
Albury, New South Wales, Australia
Local Institution - 008
Clayton, Victoria, Australia
Local Institution - 002
Geelong, Victoria, Australia
Local Institution - 003
Frankston, , Australia
Local Institution - 301
Brussels, , Belgium
Local Institution - 307
Liège, , Belgium
Local Institution - 305
Roeselare, , Belgium
Local Institution - 303
Sint-Niklaas, , Belgium
Local Institution - 368
Calgary, Alberta, Canada
Local Institution - 373
Surrey, British Columbia, Canada
Local Institution - 366
Saint John, New Brunswick, Canada
Local Institution - 362
Greenfield Park, Quebec, Canada
Local Institution - 365
Montreal, Quebec, Canada
Local Institution - 209
Beijing, , China
Local Institution - 206
Beijing, , China
Local Institution - 215
Beijing, , China
Local Institution - 200
Beijing, , China
Local Institution - 211
Changchun, , China
Local Institution - 210
Chengdu, , China
Local Institution - 213
Chongqing, , China
Local Institution - 202
Fuzhou, , China
Local Institution - 217
Guangzhou, Guangdong, , China
Local Institution - 204
Hangzhou, , China
Local Institution - 207
Harbin, Heilongjiang, , China
Local Institution - 212
Nanjing, , China
Local Institution - 205
Nanjing, Jiangsu, , China
Local Institution - 214
Shanghai, , China
Local Institution - 219
Suzhu, , China
Local Institution - 221
Tianjin, , China
Local Institution - 203
Wuhan, , China
Local Institution - 376
Brno, , Czechia
Local Institution - 377
Hradec Králové, , Czechia
Local Institution - 379
Olomouc, , Czechia
Local Institution - 380
Prague, , Czechia
Local Institution - 378
Prague, , Czechia
Local Institution - 576
Bayonne, , France
Local Institution - 585
Bordeaux, , France
Local Institution - 583
Montpellier, , France
Local Institution - 582
Paris, , France
Local Institution - 588
Pessac, , France
Local Institution - 587
Toulose, , France
Local Institution - 581
Vandœuvre-lès-Nancy, , France
Local Institution - 893
Dublin, , Ireland
Local Institution - 894
Galway, , Ireland
Local Institution - 273
Beersheba, , Israel
Local Institution - 274
Haifa, , Israel
Local Institution - 272
Jerusalem, , Israel
Local Institution - 275
Kfar Saba, , Israel
Local Institution - 277
Petah Tikva, , Israel
Local Institution - 278
Tel Aviv, , Israel
Local Institution - 270
Ẕerifin, , Israel
Local Institution - 690
Terni, Umbria, Italy
Local Institution - 659
Allessandria, , Italy
Local Institution - 658
Brescia, , Italy
Local Institution - 674
Cuneo, , Italy
Local Institution - 664
Florence, , Italy
Local Institution - 652
Genova, , Italy
Local Institution - 667
Ivrea, , Italy
Local Institution - 684
Meldola, , Italy
Local Institution - 666
Milan, , Italy
Local Institution - 653
Milan, , Italy
Local Institution - 676
Milan, , Italy
Local Institution - 657
Napoli, Campania, , Italy
Local Institution - 655
Novara, , Italy
Local Institution - 685
Padua, , Italy
Local Institution - 686
Pagani, , Italy
Local Institution - 651
Pavia, , Italy
Local Institution - 679
Ravenna, , Italy
Local Institution - 668
Reggio Emilia, , Italy
Local Institution - 683
Rimini, , Italy
Local Institution - 689
Roma, , Italy
Local Institution - 694
Roma, , Italy
Local Institution - 673
Roma, , Italy
Local Institution - 656
Rome, , Italy
Local Institution - 671
Torino, , Italy
Local Institution - 662
Torino, , Italy
Local Institution - 681
Tricase, , Italy
Local Institution - 692
Udine, , Italy
Local Institution - 682
Verona, , Italy
Local Institution - 672
Vicenza, , Italy
Local Institution - 508
Chuo-ku, Tokyo, Japan
Local Institution - 509
Koto-ku, Tokyo, Japan
Local Institution - 502
Minato-ku, Tokyo, Japan
Local Institution - 513
Akita, , Japan
Local Institution - 511
Fukuoka, , Japan
Local Institution - 505
Isehara City, Kanagawa, , Japan
Local Institution - 501
Kashiwa, , Japan
Local Institution - 510
Kyoto, , Japan
Local Institution - 506
Minami-Ku, Fukuoka, , Japan
Local Institution - 507
Nagoya, , Japan
Local Institution - 515
Sendai, , Japan
Local Institution - 504
Yamagata, , Japan
Local Institution - 353
's-Hertogenbosch, , Netherlands
Local Institution - 358
Amsterdam, , Netherlands
Local Institution - 359
Breda, , Netherlands
Local Institution - 357
Hoofddorp, , Netherlands
Local Institution - 354
Leeuwarden, , Netherlands
Local Institution - 350
Schiedam, , Netherlands
Local Institution - 240
Christchurch, , New Zealand
Local Institution - 243
Palmerston, , New Zealand
Local Institution - 730
Figueira da Foz Municipality, , Portugal
Local Institution - 732
Lisbon, , Portugal
Local Institution - 729
Lisbon, , Portugal
Local Institution - 727
Pragal, , Portugal
Local Institution - 115
San Juan, , Puerto Rico
Local Institution - 050
Kazan', , Russia
Local Institution - 052
Moscow, , Russia
Local Institution - 051
Saint Petersburg, , Russia
Local Institution - 830
Gyeonggi-do, , South Korea
Local Institution - 826
Seoul, , South Korea
Local Institution - 829
Seoul, , South Korea
Local Institution - 828
Seoul, , South Korea
Local Institution - 776
Barcelona, , Spain
Local Institution - 780
Barcelona, , Spain
Local Institution - 796
Cáceres, , Spain
Local Institution - 783
Madrid, , Spain
Local Institution - 785
Madrid, , Spain
Local Institution - 787
Madrid, , Spain
Local Institution - 788
Madrid, , Spain
Local Institution - 797
Salamanca, , Spain
Local Institution - 790
Seville, , Spain
Local Institution - 800
Seville, , Spain
Local Institution - 793
Valencia, , Spain
Local Institution - 802
Valencia, , Spain
Local Institution - 323
Bellinzona, , Switzerland
Local Institution - 320
Geneva, , Switzerland
Local Institution - 321
Winterthur, , Switzerland
Local Institution - 253
Niao-Sung Hsiang Kaohsiung County, , Taiwan
Local Institution - 255
Taichung, , Taiwan
Local Institution - 252
Taipei, Zhongzheng Dist., , Taiwan
Local Institution - 429
Adana, , Turkey (Türkiye)
Local Institution - 431
Ankara, , Turkey (Türkiye)
Local Institution - 430
Antalya, , Turkey (Türkiye)
Local Institution - 435
Denizli, , Turkey (Türkiye)
Local Institution - 428
Edirne, , Turkey (Türkiye)
Local Institution - 432
Istanbul, , Turkey (Türkiye)
Countries
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References
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Nowakowski GS, Chiappella A, Witzig TE, Spina M, Gascoyne RD, Zhang L, Flament J, Repici J, Vitolo U. ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma. Future Oncol. 2016 Jul;12(13):1553-63. doi: 10.2217/fon-2016-0130. Epub 2016 Apr 18.
Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024.
Nowakowski GS, Chiappella A, Gascoyne RD, Scott DW, Zhang Q, Jurczak W, Ozcan M, Hong X, Zhu J, Jin J, Belada D, Bergua JM, Piazza F, Mocikova H, Molinari AL, Yoon DH, Cavallo F, Tani M, Yamamoto K, Izutsu K, Kato K, Czuczman M, Hersey S, Kilcoyne A, Russo J, Hudak K, Zhang J, Wade S, Witzig TE, Vitolo U. ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2021 Apr 20;39(12):1317-1328. doi: 10.1200/JCO.20.01366. Epub 2021 Feb 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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2013-004054-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-5013-DLC-002
Identifier Type: -
Identifier Source: org_study_id
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