A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

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NCT01232556

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Study Location
Disney Family Cancer Center at Providence St Joseph Medical Center
Burbank, California, 91505, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Hodgkin 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.
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-

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


-

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Non-Hodgkin LymphomaA Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
NCT01232556
  1. Burbank, California
  2. Burbank, California
  3. Fresno, California
  4. Los Angeles, California
  5. Los Angeles, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Santa Barbara, California
  9. Santa Monica, California
  10. Solvang, California
  11. Washington, District of Columbia
  12. Aventura, Florida
  13. Boynton Beach, Florida
  14. Fernandina Beach, Florida
  15. Gainesville, Florida
  16. Gainesville, Florida
  17. Gainesville, Florida
  18. Gainesville, Florida
  19. Gainesville, Florida
  20. Gainesville, Florida
  21. Jacksonville, Florida
  22. Jacksonville, Florida
  23. Jacksonville, Florida
  24. Jacksonville, Florida
  25. Jacksonville, Florida
  26. Jacksonville, Florida
  27. Lake Worth, Florida
  28. Miami Beach, Florida
  29. Miami Beach, Florida
  30. Miami, Florida
  31. Miami, Florida
  32. Miami, Florida
  33. Orange Park, Florida
  34. Augusta, Georgia
  35. Augusta, Georgia
  36. Coeur d'Alene, Idaho
  37. Post Falls, Idaho
  38. Decatur, Illinois
  39. New Albany, Indiana
  40. Kansas City, Kansas
  41. Westwood, Kansas
  42. Lexington, Kentucky
  43. Lexington, Kentucky
  44. New Orleans, Louisiana
  45. Detroit, Michigan
  46. Farmington Hills, Michigan
  47. Saint Louis Park, Minnesota
  48. Saint Louis, Missouri
  49. Saint Louis, Missouri
  50. Saint Louis, Missouri
  51. Saint Louis, Missouri
  52. Saint Peters, Missouri
  53. Lincoln, Nebraska
  54. New York, New York
  55. New York, New York
  56. New York, New York
  57. New York, New York
  58. Stony Brook, New York
  59. Stony Brook, New York
  60. Cincinnati, Ohio
  61. West Chester, Ohio
  62. Oklahoma City, Oklahoma
  63. Oklahoma City, Oklahoma
  64. Oklahoma City, Oklahoma
  65. Oklahoma City, Oklahoma
  66. Corvallis, Oregon
  67. Corvallis, Oregon
  68. Corvallis, Oregon
  69. Newport, Oregon
  70. Hershey, Pennsylvania
  71. Sayre, Pennsylvania
  72. Sayre, Pennsylvania
  73. Knoxville, Tennessee
  74. Knoxville, Tennessee
  75. Maryville, Tennessee
  76. Sevierville, Tennessee
  77. Dallas, Texas
  78. Dallas, Texas
  79. Dallas, Texas
  80. Dallas, Texas
  81. Dallas, Texas
  82. Houston, Texas
  83. Leuven, Vlaams Brabant
  84. Bruxelles,
  85. Charleroi,
  86. Roeselare,
  87. Wilrijk,
  88. Yvoir,
  89. Plovdiv,
  90. Sofia,
  91. Sofia,
  92. Calgary, Alberta
  93. Edmonton, Alberta
  94. Toronto, Ontario
  95. Sherbrooke, Quebec
  96. Zagreb,
  97. Zagreb,
  98. Praha 10, Czech Republic
  99. Brno,
  100. Marseille, Bouches-du-rhône
  101. Marseille, Cedex 09
  102. Le Chesnay Cedex, Yvelines
  103. Le Chesnay, Yvelines
  104. Lyon,
  105. Montpellier,
  106. Pessac,
  107. Rouen,
  108. Aachen,
  109. Bamberg,
  110. Berlin,
  111. Berlin,
  112. Mainz,
  113. Muenchen,
  114. Ulm,
  115. Budapest,
  116. Debrechen,
  117. Kaposvar,
  118. Aurangabad, Maharashtra
  119. Pune, Maharashtra
  120. Pune, Maharashtra
  121. Pune, Maharashtra
  122. Cork,
  123. Nagoya, Aichi
  124. Kashiwa, Chiba
  125. Toon-shi, Ehime
  126. Maebashi-city, Gunma
  127. Sendai, Miyagi
  128. Moriguchi, Osaka
  129. Sunto-gun, Shizuoka
  130. Chuo-ku, Tokyo
  131. Koto-Ku, Tokyo
  132. Akita,
  133. Fukuoka,
  134. Kanagawa,
  135. Kyoto,
  136. Klaipeda,
  137. Aguascalientes, Aguascalientes. Mexico
  138. Warszawa,
  139. Warszawa,
  140. Catano,
  141. San Juan,
  142. Moscow,
  143. Moscow,
  144. Saint-Petersburg,
  145. Singapore,
  146. Singapore,
  147. Bratislava,
  148. Sevilla, Andalucia
  149. Salamanca, Castille AND LION
  150. Barcelona,
  151. Barcelona,
  152. L'Hospitalet De Llobregat (bcn),
  153. La Laguna (Tenerife),
  154. Madrid,
  155. Linkoping,
  156. Lund,
  157. Kuei-Shan Hsiang, Taoyuan County
  158. Taichung,
  159. Taipei,
  160. Taipei,
  161. Bangkoknoi, Bangkok
  162. Chiang Mai,
  163. Cherkasy,
  164. Dnipropetrovsk,
  165. Kyiv,
  166. London,
  167. London,
  168. London,
  169. Manchester,
  170. Newcastle upon Tyne,
  171. Newcastle upon Tyne,
  172. Newcastle upon Tyne,
  173. Nottingham,
  174. Nottingham,
  175. Nottingham,
  176. Nottingham,
  177. Wolverhampton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
Official Title  ICMJE AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY
Brief Summary The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Non-Hodgkin
Intervention  ICMJE
  • Drug: Inotuzumab ozogamicin
    1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles
    Other Name: CMC-544
  • Drug: Rituximab
    375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles
  • Drug: rituximab + gemcitabine
    rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles
  • Drug: rituximab +bendamustine
    rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles
Study Arms  ICMJE
  • Experimental: 1
    Inotuzumab ozogamicin+rituximab
    Interventions:
    • Drug: Inotuzumab ozogamicin
    • Drug: Rituximab
  • Active Comparator: 2
    Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine
    Interventions:
    • Drug: rituximab + gemcitabine
    • Drug: rituximab +bendamustine
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 24, 2018)		338
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2010)		377
Actual Study Completion Date  ICMJE March 28, 2014
Actual Primary Completion Date March 28, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-

Exclusion Criteria:

-

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 Belgium,   Bulgaria,   Canada,   Croatia,   Czechia,   France,   Germany,   Hungary,   India,   Ireland,   Japan,   Lithuania,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT01232556
Other Study ID Numbers  ICMJE B1931008
3129K5-3303 ( Other Identifier: Alias Study Number )
2010-020147-12 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
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 UCB Pharma
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

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