A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)

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NCT02213263

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Study Location
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Follicular Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma

- Ann Arbor Stage II, III, or IV

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Not a candidate for treatment with rituximab as a single-agent


- Evidence of transformation to a high grade or diffuse large B-cell lymphoma


- Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy,
or steroids


- Any prior treatment with rituximab


- Active, uncontrolled infection

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Follicular LymphomaA Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
NCT02213263
  1. Anaheim, California
  2. Anaheim, California
  3. Corona, California
  4. Downey, California
  5. Fountain Valley, California
  6. Gilroy, California
  7. Gilroy, California
  8. Gilroy, California
  9. Glendale, California
  10. Glendale, California
  11. Glendale, California
  12. Long Beach, California
  13. Los Angeles, California
  14. Los Angeles, California
  15. Lynwood, California
  16. Montebello, California
  17. Palm Springs, California
  18. Redondo Beach, California
  19. Riverside, California
  20. San Jose, California
  21. San Jose, California
  22. San Jose, California
  23. Santa Ana, California
  24. Torrance, California
  25. Whittier, California
  26. Whittier, California
  27. Aurora, Colorado
  28. Boulder, Colorado
  29. Denver, Colorado
  30. Lakewood, Colorado
  31. Lakewood, Colorado
  32. Lone Tree, Colorado
  33. Pueblo, Colorado
  34. Thomasville, Georgia
  35. Thomasville, Georgia
  36. DeKalb, Illinois
  37. Geneva, Illinois
  38. Chanute, Kansas
  39. Dodge City, Kansas
  40. El Dorado, Kansas
  41. Independence, Kansas
  42. Kingman, Kansas
  43. Liberal, Kansas
  44. McPherson, Kansas
  45. Newton, Kansas
  46. Overland Park, Kansas
  47. Parsons, Kansas
  48. Salina, Kansas
  49. Wellington, Kansas
  50. Wichita, Kansas
  51. Wichita, Kansas
  52. Winfield, Kansas
  53. Baltimore, Maryland
  54. Baltimore, Maryland
  55. Bethesda, Maryland
  56. Silver Spring, Maryland
  57. Silver Spring, Maryland
  58. Silver Spring, Maryland
  59. Wheaton, Maryland
  60. Kansas City, Missouri
  61. Kansas City, Missouri
  62. Lee's Summit, Missouri
  63. Grand Island, Nebraska
  64. Grand Island, Nebraska
  65. Hastings, Nebraska
  66. Henderson, Nevada
  67. Henderson, Nevada
  68. Las Vegas, Nevada
  69. Las Vegas, Nevada
  70. Las Vegas, Nevada
  71. Greenville, North Carolina
  72. Greenville, North Carolina
  73. Greenville, North Carolina
  74. Maumee, Ohio
  75. Toledo, Ohio
  76. Toledo, Ohio
  77. Eugene, Oregon
  78. Knoxville, Tennessee
  79. Fort Sam Houston, Texas
  80. Fort Sam Houston, Texas
  81. Fort Sam Houston, Texas
  82. Fort Worth, Texas
  83. Fort Worth, Texas
  84. Houston, Texas
  85. Irving, Texas
  86. Kingwood, Texas
  87. Longview, Texas
  88. Shenandoah, Texas
  89. The Woodlands, Texas
  90. Tyler, Texas
  91. Yakima, Washington
  92. Linz,
  93. Linz,
  94. Linz,
  95. Lesnoy, Minsk Region
  96. Lesnoy, Minsk Region
  97. Brest,
  98. Minsk,
  99. Republic Of Belarus,
  100. Brussels,
  101. Brussels,
  102. Charleroi,
  103. Charleroi,
  104. Charleroi,
  105. La Louviere (Haine-Saint Paul),
  106. La Louviere (Haine-Saint-Paul),
  107. La Louviere (Haine-Saint-Paul),
  108. Mons,
  109. Mons,
  110. Salvador, Bahia
  111. Salvador, Bahia
  112. Goiania, GO
  113. Goiania, GO
  114. Belo Horizonte, MG
  115. Belo Horizonte, MG
  116. Belo Horizonte, Minas Gerais
  117. Porto Alegre, RIO Grande DO SUL
  118. Porto Alegre, RIO Grande DO SUL
  119. Porto Alegre, RIO Grande DO SUL
  120. Porto Alegre, RIO Grande DO SUL
  121. Porto Alegre, RS
  122. Porto Alegre, RS
  123. Porto Alegre, RS
  124. Jau, SAO Paulo
  125. Jau, SAO Paulo
  126. Jaú, SAO Paulo
  127. Santo Andre, SAO Paulo
  128. Sao Bernardo do Campo, SAO Paulo
  129. Campinas, SP
  130. Campinas, SP
  131. Campinas, SP
  132. Campinas, SP
  133. Campinas, SP
  134. Santo Andre, SP
  135. Sao Paulo, SP
  136. Sao Paulo, SP
  137. Sao Paulo, SP
  138. São Paulo, SP
  139. Sao Paulo,
  140. Sao Paulo,
  141. Zagreb,
  142. Zagreb,
  143. Zagreb,
  144. Zagreb,
  145. Zagreb,
  146. Marseille, Marseille Cedex 05
  147. Mulhouse, Mulhouse Cedex
  148. Boulogne Sur Mer, NAP
  149. Boulogne Sur Mer,
  150. Bourg En Bresse Cedex,
  151. Brest,
  152. Caen,
  153. Le Mans,
  154. Lyon,
  155. Tbilisi,
  156. Tbilisi,
  157. Tbilisi,
  158. Berlin,
  159. Berlin,
  160. Berlin,
  161. Berlin,
  162. Berlin,
  163. Chemnitz,
  164. Chemnitz,
  165. Chemnitz,
  166. Chemnitz,
  167. Essen,
  168. Essen,
  169. Herne,
  170. Herne,
  171. Herne,
  172. Koeln,
  173. Mutlangen,
  174. Mutlangen,
  175. Mutlangen,
  176. Rostock,
  177. Stuttgart,
  178. Stuttgart,
  179. Troisdorf,
  180. Troisdorf,
  181. Troisdorf,
  182. Athens,
  183. Athens,
  184. Athens,
  185. Athens,
  186. Athens,
  187. Athens,
  188. Athens,
  189. Athens,
  190. Athens,
  191. Chaidari, Athens,
  192. Patras,
  193. Patras,
  194. Surat, Gujarat
  195. Surat, Gujarat
  196. Surat, Gujarat
  197. Mangalore, Karanataka
  198. Bangalore, Karnataka
  199. Manipal, Karnataka
  200. Nashik, Maharashtra
  201. Nashik, Maharashtra
  202. Pune, Maharashtra
  203. Pune, Maharashtra
  204. Pune, Maharashtra
  205. Jaipur, Rajasthan
  206. Chennai, Tamilnadu
  207. Chennai, Tamilnadu
  208. Hyderabad, Telangana
  209. Hyderabad, Telangana
  210. Kolkata, WEST Bengal
  211. Kolkata, WEST Bengal
  212. New Delhi,
  213. Cremona, CR
  214. Meldola, FC
  215. Genova, GE
  216. Monza, MB
  217. Milano, MI
  218. Latina, NAP
  219. Torrette Ancona, Palermo
  220. Terni, PG
  221. Reggio Emilia, Reggio
  222. Reggio Emilia, Reggio
  223. Reggio Emilia, Reggio
  224. Rome, Rome Rm
  225. Genova,
  226. Milano,
  227. Parma,
  228. Pesaro,
  229. Pisa,
  230. Roma,
  231. Nagoya, Aichi
  232. Nagoya, Aichi
  233. Akita City, Akita
  234. Chiba-shi, Chiba
  235. Fukuoka-shi, Fukuoka
  236. Fukuoka-Shi, Fukuoka
  237. Kobe-City, Hyogo
  238. Kanazawa, Ishikawa
  239. Kanazawa, Ishikawa
  240. Yokohama-shi, Kanagawa-ken
  241. Okocho, Nankoku, Kochi
  242. Kumamoto-shi, Kumamoto-ken
  243. Kumamoto-shi, Kumamoto-ken
  244. Sendai-shi, Miyagi
  245. Sendai-shi, Miyagi
  246. Matsumoto-shi, Nagano
  247. Nagano-shi, Nagano
  248. Omura, Nagasaki
  249. Kawachinagano, Osaka
  250. Naka-ku Sakai, Osaka
  251. Osaka-City, Osaka
  252. Tokushima-Shi, Tokushima
  253. Meguro-Ku, Tokyo
  254. Shinagawa-ku, Tokyo
  255. Tachikawa, Tokyo
  256. Yamagata-Shi, Yamagata
  257. Fukuoka,
  258. Nagano,
  259. Tokyo,
  260. Anyang-si, Gyeonggi-do
  261. Seongnam-si, Gyeonggi-do
  262. Jeonju-si, Jeollabuk-do
  263. Ulsan, Korea
  264. Busan,
  265. Seoul,
  266. Seoul,
  267. Saida, Southern Governate
  268. Beirut,
  269. Beirut,
  270. El Metn,
  271. Mount Lebanon,
  272. Mexico City, Distrito Federal
  273. Mexico City, Distrito Federal
  274. Mexico City, Distrito Federal
  275. Cuautitlan Izacalli, Estado DE Mexico
  276. Cuautitlan Izcalli, Estado DE Mexico
  277. Monterrey, Nuevo LEON
  278. Monterrey, Nuevo LEON
  279. Oaxaca,
  280. Oaxaca,
  281. Puebla,
  282. Queretaro,
  283. Queretaro,
  284. Queretaro,
  285. Surquillo, Lima
  286. Lima,
  287. Lima,
  288. Manila, Metro Manila
  289. Quezon City,
  290. Warszawa,
  291. Wroclaw,
  292. Wroclaw,
  293. Wroclaw,
  294. Wroclaw,
  295. Wroclaw,
  296. Matosinhos, Porto
  297. Braga,
  298. Lisboa,
  299. Porto,
  300. Porto,
  301. Porto,
  302. Porto,
  303. Vila Nova de Gaia,
  304. Coto Laurel,
  305. Ponce,
  306. Ponce,
  307. Brasov,
  308. Brasov,
  309. Bucuresti,
  310. Bucuresti,
  311. Bucuresti,
  312. Bucuresti,
  313. Bucuresti,
  314. Cluj-Napoca,
  315. Cluj-Napoca,
  316. Cluj-Napoca,
  317. Cluj-Napoca,
  318. Obninsk, Kaluga Region
  319. Saransk, Mordovian Republic
  320. Nizhniy Novgorod, Nizhniy Novgorod Region
  321. Nizhniy Novgorod, Nizhniy Novgorod Region
  322. Saint-Petersburg, Pesochniy TOWN
  323. Saint-Petersburg, Pesochniy TOWN
  324. Saint-Petersburg, Pesochniy TOWN
  325. Saint-Petersburg, Pesochniy TOWN
  326. Saint-Petersburg, Pesochniy
  327. Saint-Petersburg, Pesochniy
  328. Saint-Petersburg, Pesochniy
  329. Saint-Petersburg, Pos.pesochny
  330. Ufa, Republic Bashkortostan
  331. Ufa, Republic Bashkortostan
  332. Pushkin, Saint Petersburg
  333. Pesochniy Town, Saint-petersburg
  334. Lermontov, Stavropol Region
  335. Pyatigorsk, Stavropol Region
  336. Chelyabinsk,
  337. Moscow,
  338. Moscow,
  339. Moscow,
  340. Moscow,
  341. Moscow,
  342. Saint Petersburg,
  343. Saint-Petersburg,
  344. Saint-Petersburg,
  345. Saint-Petersburg,
  346. Saint-Petersurg,
  347. Yaroslavl,
  348. Yaroslavl,
  349. Groenkloof, Gauteng
  350. Johannesburg, Gauteng
  351. Pretoria, Gauteng
  352. Pretoria, Gauteng
  353. Pretoria, Gauteng
  354. Pretoria, Gauteng
  355. Rosebank, Gauteng
  356. Sandton, Gauteng
  357. Sabadell, Barcelona
  358. San Sebastian, Guipuzcoa
  359. Aravaca, Madrid
  360. Mostoles, Madrid
  361. El Palmar, Murcia
  362. El Palmar, Murcia
  363. Vigo, Pontevedra
  364. A Coruna,
  365. A Coruna,
  366. Barcelona,
  367. Barcelona,
  368. Barcelona,
  369. Barcelona,
  370. Cadiz,
  371. Madrid,
  372. Madrid,
  373. Malaga,
  374. Malaga,
  375. Malaga,
  376. Ourense,
  377. Sevilla,
  378. Zaragoza,
  379. Zaragoza,
  380. Basel,
  381. Bern,
  382. Thun,
  383. Thun,
  384. Zuerich,
  385. Zuerich,
  386. Bangkok,
  387. Bangkok,
  388. Bangkok,
  389. Ankara,
  390. Ankara,
  391. Ankara,
  392. Ankara,
  393. Ankara,
  394. Aydin,
  395. Gaziantep,
  396. Gaziantep,
  397. Istanbul,
  398. Izmir,
  399. Izmir,
  400. Kayseri,
  401. Kayseri,
  402. Kayseri,
  403. Malatya,
  404. Manisa,
  405. Samsun,
  406. Obukhiv District, KYIV Region
  407. Obukhiv District, KYIV Region
  408. Obukhiv, KYIV Region
  409. Chernivtsi,
  410. Dnipropetrovsk,
  411. Kharkiv,
  412. Kyiv,
  413. Uzhhorod,
  414. Vinnytsia,
  415. Zaporizhzhia,
  416. Zaporizhzhia,
  417. Westcliff-On-Sea, Essex
  418. Cheltenham, Glos.
  419. Bath,
  420. London,
  421. Newcastle upon Tyne,
  422. Sunderland,
  423. Sunderland,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA
Brief Summary This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE
  • Biological: PF-05280586
    PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
  • Biological: MabThera®
    MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
Study Arms  ICMJE
  • Experimental: PF-05280586
    Intervention: Biological: PF-05280586
  • Active Comparator: MabThera®
    Intervention: Biological: MabThera®
Publications * Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I. A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera(®)) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs. 2020 Apr;34(2):171-181. doi: 10.1007/s40259-019-00398-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2014)		394
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 19, 2018
Actual Primary Completion Date October 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma
  • Ann Arbor Stage II, III, or IV

Exclusion Criteria:

  • Not a candidate for treatment with rituximab as a single-agent
  • Evidence of transformation to a high grade or diffuse large B-cell lymphoma
  • Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy, or steroids
  • Any prior treatment with rituximab
  • Active, uncontrolled infection
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belarus,   Belgium,   Brazil,   Croatia,   France,   Georgia,   Germany,   Greece,   India,   Italy,   Japan,   Korea, Republic of,   Lebanon,   Mexico,   Peru,   Philippines,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   South Africa,   Spain,   Switzerland,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213263
Other Study ID Numbers  ICMJE B3281006
2014-000132-41 ( EudraCT Number )
REFLECTIONS ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP