Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy

NCT02312037

Last updated date
Study Location
University of Alabama at Birmingham/Children's of Alabama
Birmingham, Alabama, 35233, United States
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.
CD33 Positive Acute Myelogenous Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3 + months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Confirmed diagnosis of relapsed/refractory AML (defined as >=5% marrow blasts by morphology), including MDS, with persisting rising blasts and no other comparable or satisfactory alternative therapy available. If bone marrow has <5% blasts by morphology but the patient has evidence of relapse with extra-medullary disease progression. In select cases presenting with conversion of MRD from negative to positive, treatment with GO may be allowed where no alternative treatments are feasible.

OR

- Confirmed diagnosis of relapsed or refractory APL with persisting or rising leukemic burden (either by morphology, cytogenetic analysis or by molecular techniques), and no other comparable or satisfactory alternative therapy available.

- Documentation that malignant cells express CD33

4) Age >=3 months

5) Adequate non-hematologic organ function

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


- Untreated AML and MDS or AML and MDS in complete remission.


- Patients with a known history of VOD/SOS.


- Patients with a known hypersensitivity to Mylotarg or its parts: hP67.6 antibody,
calicheamicin derivatives or other ingredients.


- Participation in other studies involving investigational drug(s) (Phases 1-4) during
study participation.

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

CD33 Positive Acute Myelogenous LeukemiaExpanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy NCT02312037
  1. Birmingham, Alabama
  2. Anchorage, Alaska
  3. Anchorage, Alaska
  4. Anchorage, Alaska
  5. Mesa, Arizona
  6. Mesa, Arizona
  7. Phoenix, Arizona
  8. Los Angeles, California
  9. Oakland, California
  10. Oakland, California
  11. Orange, California
  12. Roseville, California
  13. San Diego, California
  14. Santa Clara, California
  15. New Haven, Connecticut
  16. New Haven, Connecticut
  17. New Haven, Connecticut
  18. New Haven, Connecticut
  19. Trumbull, Connecticut
  20. Wilmington, Delaware
  21. Washington, District of Columbia
  22. Hollywood, Florida
  23. Hollywood, Florida
  24. Hollywood, Florida
  25. Jacksonville, Florida
  26. Jacksonville, Florida
  27. Orlando, Florida
  28. Orlando, Florida
  29. Orlando, Florida
  30. Orlando, Florida
  31. Pembroke Pines, Florida
  32. Pembroke Pines, Florida
  33. Saint Petersburg, Florida
  34. Saint Petersburg, Florida
  35. Saint Petersburg, Florida
  36. Tampa, Florida
  37. Atlanta, Georgia
  38. Atlanta, Georgia
  39. Atlanta, Georgia
  40. Atlanta, Georgia
  41. Chicago, Illinois
  42. Chicago, Illinois
  43. Chicago, Illinois
  44. Chicago, Illinois
  45. Chicago, Illinois
  46. Maywood, Illinois
  47. Maywood, Illinois
  48. Maywood, Illinois
  49. Indianapolis, Indiana
  50. Indianapolis, Indiana
  51. Indianapolis, Indiana
  52. Indianapolis, Indiana
  53. Indianapolis, Indiana
  54. Kansas City, Kansas
  55. Westwood, Kansas
  56. Westwood, Kansas
  57. Westwood, Kansas
  58. Lexington, Kentucky
  59. Baltimore, Maryland
  60. Baltimore, Maryland
  61. Boston, Massachusetts
  62. Rochester, Minnesota
  63. Southaven, Mississippi
  64. Creve Coeur, Missouri
  65. Kansas City, Missouri
  66. Saint Louis, Missouri
  67. Saint Louis, Missouri
  68. Saint Louis, Missouri
  69. Saint Louis, Missouri
  70. Saint Louis, Missouri
  71. New Brunswick, New Jersey
  72. New Brunswick, New Jersey
  73. Buffalo, New York
  74. East Setauket, New York
  75. New York, New York
  76. New York, New York
  77. New York, New York
  78. Rochester, New York
  79. Rochester, New York
  80. Greenville, North Carolina
  81. Greenville, North Carolina
  82. Cleveland, Ohio
  83. Columbus, Ohio
  84. Danville, Pennsylvania
  85. Hershey, Pennsylvania
  86. Philadelphia, Pennsylvania
  87. Philadelphia, Pennsylvania
  88. Philadelphia, Pennsylvania
  89. Philadelphia, Pennsylvania
  90. Philadelphia, Pennsylvania
  91. Philadelphia, Pennsylvania
  92. Philadelphia, Pennsylvania
  93. Pittsburgh, Pennsylvania
  94. Germantown, Tennessee
  95. Knoxville, Tennessee
  96. Memphis, Tennessee
  97. Memphis, Tennessee
  98. Memphis, Tennessee
  99. Nashville, Tennessee
  100. Nashville, Tennessee
  101. Nashville, Tennessee
  102. Nashville, Tennessee
  103. Nashville, Tennessee
  104. Nashville, Tennessee
  105. Nashville, Tennessee
  106. Nashville, Tennessee
  107. Nashville, Tennessee
  108. Nashville, Tennessee
  109. Nashville, Tennessee
  110. Nashville, Tennessee
  111. Austin, Texas
  112. Austin, Texas
  113. Austin, Texas
  114. El Paso, Texas
  115. El Paso, Texas
  116. Fort Worth, Texas
  117. Fort Worth, Texas
  118. Grapevine, Texas
  119. Houston, Texas
  120. Houston, Texas
  121. Houston, Texas
  122. Houston, Texas
  123. Salt Lake City, Utah
  124. Salt Lake City, Utah
  125. Salt Lake City, Utah
  126. Charlottesville, Virginia
  127. Charlottesville, Virginia
  128. Charlottesville, Virginia
  129. Hampton, Virginia
  130. Norfolk, Virginia
  131. Virginia Beach, Virginia
  132. Seattle, Washington
  133. Seattle, Washington
  134. Seattle, Washington
  135. Seattle, Washington
  136. Appleton, Wisconsin
  137. Green Bay, Wisconsin
  138. Milwaukee, Wisconsin
  139. Milwaukee, Wisconsin
  140. Oshkosh, Wisconsin
  141. Wauwatosa, Wisconsin
  142. West Allis, Wisconsin
ALL GENDERS
3 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
Brief Summary

An expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA.

Contact: [email protected]

Detailed Description

Contact:

[email protected]

Study Type Expanded Access
Intervention Biological: Antibody Drug Conjugate Chemotherapeutic

Three Treatment Regimens:

  1. Mylotarg <=9 mg/m2 as a single agent on Day 1 & 14 of a 28-day cycle for a total of two cycles
  2. Mylotarg in combination with a recognized anthracycline and/or nucleoside-antagonist containing regimen
  3. Mylotarg as monotherapy or in tested combinations with ATRA and/or arsenic trioxide for APL
Other Name: Gemtuzumab ozogamicin
Publications * Wang ES, Aplenc R, Chirnomas D, Dugan M, Fazal S, Iyer S, Lin TL, Nand S, Pierce KJ, Shami PJ, Vermette JJ, Abboud CN. Safety of gemtuzumab ozogamicin as monotherapy or combination therapy in an expanded-access protocol for patients with relapsed or refractory acute myeloid leukemia. Leuk Lymphoma. 2020 May 20:1-9. doi: 10.1080/10428194.2020.1742897. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Spain
 
Administrative Information
NCT Number NCT02312037
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2019