Back to resultsStudy Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gemtuzumab Ozogamicin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute, Myeloid, Leukemia
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037583
First Posted
May 17, 2002
Last Updated
August 20, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00037583
Brief Title
Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute, Myeloid, Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemtuzumab Ozogamicin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
30062662
Citation
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.
Results Reference
derived
Learn more about this trial
Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia
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