A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World

NCT04337138

Last updated date
Contact
1-800-718-1021

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.
Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Confirmed diagnosis of acute myeloid leukemia (AML) on or after 01 December 2014 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record;

- Receipt of Mylotarg at any point during first three lines of therapy following initial AML diagnosis;

- Age greater than or equal to 18 years at initial diagnosis of AML.

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


- Record of 1 or more of the following confounding diagnoses at any point before or after
AML diagnosis: Acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive
systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia;
dermatofibrosarcoma protuberans; gastrointestinal stromal tumors.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Myeloid LeukemiaAcute Myeloid Leukemia Real World Treatment Patterns NCT04230564
  1. Memphis, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Myeloid LeukemiaA Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia NCT03416179
  1. Munich, Bavaria
  2. Los Angeles, California
  3. Los Angeles, California
  4. Los Angeles, California
  5. Los Angeles, California
  6. Los Angeles, California
  7. Orange, California
  8. Orange, California
  9. San Francisco, California
  10. San Francisco, California
  11. San Francisco, California
  12. Westlake Village, California
  13. Augusta, Georgia
  14. Augusta, Georgia
  15. Augusta, Georgia
  16. Boston, Massachusetts
  17. Boston, Massachusetts
  18. Boston, Massachusetts
  19. Kansas City, Missouri
  20. Lake Success, New York
  21. Manhasset, New York
  22. New Hyde Park, New York
  23. Rochester, New York
  24. Rochester, New York
  25. Cleveland, Ohio
  26. Cleveland, Ohio
  27. Cleveland, Ohio
  28. Portland, Oregon
  29. Portland, Oregon
  30. Portland, Oregon
  31. Nashville, Tennessee
  32. Nashville, Tennessee
  33. Dallas, Texas
  34. Dallas, Texas
  35. San Antonio, Texas
  36. San Antonio, Texas
  37. San Antonio, Texas
  38. Seattle, Washington
  39. Seattle, Washington
  40. Seattle, Washington
  41. Darlinghurst, New South Wales
  42. Kogarah, New South Wales
  43. Adelaide, South Australia
  44. Adelaide, South Australia
  45. Salzburg,
  46. Salzburg,
  47. Wien,
  48. Wien,
  49. Brugge,
  50. Brussels,
  51. Brussels,
  52. Leuven,
  53. Winnipeg, Manitoba
  54. Winnipeg, Manitoba
  55. Toronto, Ontario
  56. Toronto, Ontario
  57. Montreal, Quebec
  58. Saskatoon, Saskatchewan
  59. Saskatoon, Saskatchewan
  60. Hefei, Anhui
  61. Hefei, Anhui
  62. Fuzhou, Fujian
  63. Guangzhou, Guangdong
  64. Guangzhou, Guangdong
  65. Langfang, Hebei
  66. Zhengzhou, Henan
  67. Zhengzhou, Henan
  68. Wuhan, Hubei
  69. Chengdu, Sichuan
  70. Tianjin, Tianjin
  71. Hangzhou, Zhejiang
  72. Shanghai,
  73. Brno,
  74. Brno,
  75. Ostrava - Poruba,
  76. Ostrava-Poruba,
  77. Praha 10,
  78. Praha 10,
  79. Creteil,
  80. Créteil,
  81. Nantes cedex 1,
  82. Nantes cedex,
  83. Paris,
  84. Pierre Benite cedex,
  85. Pierre Benite cedex,
  86. Villejuif cedex,
  87. Marburg, Hesse
  88. Koeln, North Rhine Westphalia
  89. Muenster, North Rhine-westphalia
  90. Muenster, North-rhine-westphalia
  91. Hamburg,
  92. Hannover,
  93. Debrecen,
  94. Debrecen,
  95. Győr,
  96. Győr,
  97. Kaposvar,
  98. Nyiregyhaza,
  99. Nyiregyhaza,
  100. Haifa,
  101. Jerusalem,
  102. Jerusalem,
  103. Petah Tikva,
  104. Petah Tikva,
  105. Torrette Di Ancona, Ancona
  106. Torette Di Ancona, AN
  107. Cona, Ferrara, FE
  108. Ferrara, FE
  109. Pesaro, PU
  110. Siena, SI
  111. Bologna,
  112. Siena,
  113. Nagoya, Aichi
  114. Yoshida-gun, Fukui
  115. Maebashi, Gunma
  116. Kobe-shi, Hyogo
  117. Yokohama, Kanagawa
  118. Sendai, Miyagi
  119. Osaka-City, Osaka
  120. Osaka-Sayama, Osaka
  121. Sunto-gun, Shizuoka
  122. Tachikawa, Tokyo
  123. Akita,
  124. Fukuoka,
  125. Kumamoto,
  126. Nagasaki,
  127. Tokyo,
  128. Jeonju-si, Jeollabuk-do
  129. Busan,
  130. Busan,
  131. Daegu,
  132. Daegu,
  133. Incheon,
  134. Seoul,
  135. Seoul,
  136. Seoul,
  137. Seoul,
  138. Seoul,
  139. Seoul,
  140. Seoul,
  141. Seoul,
  142. México, MÉX
  143. Monterrey, Nuevo LEON
  144. Gdansk,
  145. Lodz,
  146. Cluj-Napoca, Cluj
  147. Craiova, Dolj
  148. Bucuresti,
  149. Bucuresti,
  150. Moscow,
  151. Moscow,
  152. Nizhniy Novgorod,
  153. Ryazan,
  154. Saint Petersburg,
  155. Saint Petersburg,
  156. Barcelona,
  157. Barcelona,
  158. Lleida,
  159. Madrid,
  160. Madrid,
  161. Sevilla,
  162. Valencia,
  163. Orebro,
  164. Orebro,
  165. Solna,
  166. Stockholm,
  167. Tainan,
  168. Taipei,
  169. Taipei,
  170. Taipei,
  171. Taipei,
  172. Taipei,
  173. Taoyuan City,
  174. Taoyuan City,
  175. Sutton, Surrey
  176. Birmingham, WEST Midlands
  177. Birmingham, WEST Midlands
  178. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World
Official Title Characteristics, Treatment Patterns, and Clinical Outcomes in Acute Myeloid Leukemia (AML) Patients Using Mylotarg - a US Real-World Study Using Electronic Medical Record Data
Brief Summary The aim of this observational study is to describe treatment patterns and effectiveness outcomes in a sample of oncology patients treated for AML with Mylotarg through up to two additional relapsed/refractory (R/R)-based lines of therapy (through third-line therapy). The study will use United States oncology electronic medical record (EMR) data. All study data are secondary data and will have been collected retrospectively from existing clinical data originally collected as part of routine care.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will include adult patients diagnosed with AML who, at any point on or after September 1, 2017 received Mylotarg, alone or in combination with other agents for newly diagnosed or relapsed refractory AML.
Condition Leukemia, Myeloid, Acute
Intervention Drug: Gemtuzumab Ozogamicin
Gemtuzumab Ozogamicin (Mylotarg) administered in any form or combination
Other Name: Mylotarg
Study Groups/Cohorts Not Provided
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 Recruiting
Estimated Enrollment
 (submitted: May 6, 2020)
1
Original Estimated Enrollment
 (submitted: April 6, 2020)
30
Estimated Study Completion Date June 4, 2020
Estimated Primary Completion Date June 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Confirmed diagnosis of acute myeloid leukemia (AML) on or after 01 December 2014 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record;
  • Receipt of Mylotarg at any point during first three lines of therapy following initial AML diagnosis;
  • Age greater than or equal to 18 years at initial diagnosis of AML.

Exclusion Criteria:

- Record of 1 or more of the following confounding diagnoses at any point before or after AML diagnosis: Acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia; dermatofibrosarcoma protuberans; gastrointestinal stromal tumors.

Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04337138
Other Study ID Numbers B1761033
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
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….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020