Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia
NCT00037583
ABOUT THIS STUDY
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- All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
- Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
- Phase II will only allow enrollment of younger de novo AML
- AML following an antecedent hematologic disorder (myelodysplasia or
myeloproliferation) of greater than 2 months duration
- De novo patients with M3 AML
- AML secondary to exposure to chemotherapy or radiation
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Descriptive Information | |||
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Brief Title ICMJE | Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia | ||
Official Title ICMJE | A Dose-Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (go) Given in Combination With Cytarabine and Daunorubicin in Relapsed or Refractory Patients and in Younger de Novo Patients With Acute Myeloid Leukemia (AML) | ||
Brief Summary | The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin. | ||
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 | Drug: Gemtuzumab Ozogamicin | ||
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 | ||
Actual Enrollment ICMJE | 69 | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date ICMJE | September 2003 | ||
Actual Primary Completion Date | September 2003 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
Sex/Gender ICMJE |
| ||
Ages ICMJE | 18 Years to 59 Years (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 | NCT00037583 | ||
Other Study ID Numbers ICMJE | 0903B1-206 | ||
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 | Not Provided | ||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||
Verification Date | August 2009 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |