A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

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NCT01564784

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Study Location
Investigational Drug Services - UC San Diego Moores Cancer Center
La Jolla, California, 92037-0845, United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Lymphoblastic Leukemia
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

- CD22 expression

- Adequate liver and renal functions

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


- Isolated extramedullary disease


- Active Central Nervous System [CNS] disease

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Acute Lymphoblastic LeukemiaA Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
NCT01564784
  1. La Jolla, California
  2. La Jolla, California
  3. La Jolla, California
  4. Los Angeles, California
  5. Los Angeles, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Los Angeles, California
  13. Los Angeles, California
  14. Orange, California
  15. Orange, California
  16. Orange, California
  17. Palo Alto, California
  18. San Diego, California
  19. Stanford, California
  20. Stanford, California
  21. Stanford, California
  22. Aurora, Colorado
  23. Aurora, Colorado
  24. Aurora, Colorado
  25. New Haven, Connecticut
  26. Miami, Florida
  27. Orlando, Florida
  28. Orlando, Florida
  29. Orlando, Florida
  30. Orlando, Florida
  31. Atlanta, Georgia
  32. Atlanta, Georgia
  33. Atlanta, Georgia
  34. Atlanta, Georgia
  35. Atlanta, Georgia
  36. Atlanta, Georgia
  37. Augusta, Georgia
  38. Augusta, Georgia
  39. Chicago, Illinois
  40. Chicago, Illinois
  41. Chicago, Illinois
  42. Chicago, Illinois
  43. Chicago, Illinois
  44. Iowa City, Iowa
  45. Kansas City, Kansas
  46. Westwood, Kansas
  47. Louisville, Kentucky
  48. Louisville, Kentucky
  49. Baltimore, Maryland
  50. Baltimore, Maryland
  51. Baltimore, Maryland
  52. Boston, Massachusetts
  53. Boston, Massachusetts
  54. Boston, Massachusetts
  55. Ann Arbor, Michigan
  56. Detroit, Michigan
  57. Farmington Hills, Michigan
  58. Hackensack, New Jersey
  59. Hackensack, New Jersey
  60. New Brunswick, New Jersey
  61. Albuquerque, New Mexico
  62. Albuquerque, New Mexico
  63. Lake Success, New York
  64. Manhasset, New York
  65. New York, New York
  66. New York, New York
  67. New York, New York
  68. Rochester, New York
  69. Stony Brook, New York
  70. Stony Brook, New York
  71. Stony Brook, New York
  72. Stony Brook, New York
  73. Chapel Hill, North Carolina
  74. Chapel Hill, North Carolina
  75. Winston-Salem, North Carolina
  76. Cincinnati, Ohio
  77. Cleveland, Ohio
  78. Cleveland, Ohio
  79. Oklahoma City, Oklahoma
  80. Oklahoma City, Oklahoma
  81. Hershey, Pennsylvania
  82. Hershey, Pennsylvania
  83. Charleston, South Carolina
  84. Charleston, South Carolina
  85. Dallas, Texas
  86. Dallas, Texas
  87. Dallas, Texas
  88. Dallas, Texas
  89. Dallas, Texas
  90. Dallas, Texas
  91. Houston, Texas
  92. Salt Lake City, Utah
  93. Seattle, Washington
  94. Seattle, Washington
  95. Morgantown, West Virginia
  96. Morgantown, West Virginia
  97. Cordoba,
  98. Adelaide, South Australia
  99. Box Hill, Victoria
  100. Toronto, Ontario
  101. Guangzhou, Guangdong
  102. Zhengzhou, Henan
  103. Changchun, Jilin
  104. Beijing,
  105. Beijing,
  106. Beijing,
  107. Tianjin,
  108. Brno,
  109. Hradec Kralove,
  110. Praha 10,
  111. Helsinki,
  112. Helsinki,
  113. Dijon,
  114. Grenoble Cedex 09,
  115. Le Chesnay Cedex,
  116. Limoges Cedex,
  117. Marseille,
  118. Paris Cedex 10,
  119. Pierre Benite Cedex,
  120. Saint Priest en Jarez Cedex,
  121. Toulouse Cedex 9,
  122. Vandoeuvre-les-Nancy,
  123. Muenster, Nordrhein-westfalen
  124. Frankfurt,
  125. Heidelberg,
  126. Köln,
  127. Muenchen,
  128. Muenster,
  129. Muenster,
  130. Budapest,
  131. Debrecen,
  132. Cagliari, CA
  133. Cagliari, CA
  134. Cagliari, CA
  135. Meldola (FC), FC
  136. Bologna,
  137. Catania,
  138. Catania,
  139. Cona, Ferrara,
  140. Genova,
  141. Genova,
  142. Genova,
  143. Genova,
  144. Genova,
  145. Milano,
  146. Milano,
  147. Milano,
  148. Monza,
  149. Monza,
  150. Napoli,
  151. Napoli,
  152. Pavia,
  153. Ravenna,
  154. Ravenna,
  155. Ravenna,
  156. Udine,
  157. Udine,
  158. Nagoya, Aichi
  159. Nishinomiya-shi, Hyogo
  160. Sendai, Miyagi
  161. Osaka-city, Osaka
  162. Chuo-ku, Tokyo
  163. Akita,
  164. Fukuoka,
  165. Kanagawa,
  166. Hwasun-Gun, Jeonnam
  167. Seoul,
  168. Seoul,
  169. Rotterdam, South Holland
  170. Rotterdam, South Holland
  171. Gdansk,
  172. Lodz,
  173. Warsaw,
  174. Wroclaw,
  175. Singapore,
  176. Singapore,
  177. Badalona, Barcelona
  178. Salamanca, Castille AND LION
  179. Barcelona, Catalonia
  180. Palma de Mallorca, Mallorca
  181. Barcelona,
  182. Madrid,
  183. Madrid,
  184. Madrid,
  185. Murcia,
  186. Sevilla,
  187. Valencia,
  188. Lund,
  189. Stockholm,
  190. Kaohsiung,
  191. Taipei,
  192. Southampton, Hampshire
  193. Bristol,
  194. Hull,
  195. London,
  196. Manchester,
  197. Nottingham,
  198. Oxford,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
Official Title  ICMJE AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
Brief Summary This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
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 Acute Lymphoblastic Leukemia
Intervention  ICMJE
  • Drug: inotuzumab ozogamicin
    Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
  • Drug: FLAG (fludarabine, cytarabine and G-CSF)
    Dose: cytarabine 2.0 g/m^2/day IV days 1-6 fludarabine30 mg/m^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4
  • Drug: HIDAC (high dose cytarabine)
    cytarabine 3 g/m^2 IV every 12 hours for up to 12 times
  • Drug: cytarabine and mitoxantrone
    mitoxantrone 12 mg/m^2 IV days 1-3 cytarabine 200 mg/m^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4
Study Arms  ICMJE
  • Experimental: Arm A
    Intervention: Drug: inotuzumab ozogamicin
  • Active Comparator: Arm B
    Interventions:
    • Drug: FLAG (fludarabine, cytarabine and G-CSF)
    • Drug: HIDAC (high dose cytarabine)
    • Drug: cytarabine and mitoxantrone
Publications *

*   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: December 20, 2018)		326
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2012)		292
Actual Study Completion Date  ICMJE January 4, 2017
Actual Primary Completion Date March 8, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • CD22 expression
  • Adequate liver and renal functions

Exclusion Criteria:

  • Isolated extramedullary disease
  • Active Central Nervous System [CNS] disease
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 Argentina,   Australia,   Canada,   China,   Czechia,   Finland,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Singapore,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Belgium,   Brazil,   Croatia,   Czech Republic,   Serbia,   Slovakia
 
Administrative Information
NCT Number  ICMJE NCT01564784
Other Study ID Numbers  ICMJE B1931022
2011-005491-41 ( EudraCT 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 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