Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia
NCT00037596
ABOUT THIS STUDY
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- Morphologic diagnosis of AML from bone marrow aspirate and biopsy
- Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33+, based on local laboratory criteria
- Age 18 years or older for relapsed or refractory patients for Phase I of this study
- Patients with de novo AML of the M3 subtype
- AML following an antecedent hematologic disorder (myelodysplasia or
myeloproliferation) of > 2 months duration
- AML secondary to exposure to chemotherapy or radiation
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia | |||
Official Title ICMJE | A Dose Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) Given in Combination With Cytarabine in Relapsed or Refractory Patients and Alder De Novo Patients With Acute Myeloid Leukemia. | |||
Brief Summary | The primary objectives are a) to establish the maximum tolerated dose of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE | Acute Myeloid Leukemia | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Not Provided | |||
Publications * | Hibma J, Knight B. Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia. Clin Pharmacokinet. 2019 Mar;58(3):335-347. doi: 10.1007/s40262-018-0699-5. | |||
* 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 | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | April 2003 | |||
Actual Primary Completion Date | April 2003 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00037596 | |||
Other Study ID Numbers ICMJE | 0903B1-205 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |