Back to resultsStudy Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gemtuzumab Ozogamicin
cytarabine.
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037596
First Posted
May 17, 2002
Last Updated
February 11, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00037596
Brief Title
Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 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 of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemtuzumab Ozogamicin
Intervention Type
Drug
Intervention Name(s)
cytarabine.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
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 Gemtuzumab Ozogamicin in Acute Myeloid Leukemia
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