Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant
A Dose-Finding Study of the Safety of Gemtuzumab Ozogamicin as Single Agent Treatment of Patients With Relapsed Acute Myelogenous Leukemia After Autologous or Allogenic Hematopoietic Stem Cell Transplant (HSCT)
1 other identifier
interventional
38
1 country
13
Brief Summary
The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9 mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms of the number of patients attaining a complete (CR) or morphological (CRp) remission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2000
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 4, 2002
CompletedFirst Posted
Study publicly available on registry
September 6, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedMay 18, 2006
May 1, 2006
September 4, 2002
May 17, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients with CD33+ AML who have experienced relapse after autologous or allogeneic HSCT. Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33 positive, based on local laboratory criteria (Patients with history of MDS pretransplant will be eligible if their proportion of myeloblasts by marrow aspirate exceeds 5% at time of evaluation for Gemtuzumab Ozogamicin treatment)
- The patient must be greater than or equal to 60 days post-HCST
- Patients of all ages may be entered in this study
You may not qualify if:
- Peripheral white blood count (WBC) greater than or equal to 30,000/uL at the time of initial Gemtuzumab Ozogamicin administration. (In order to reduce the peripheral blood count, patients may be treated with Hydroxyurea. Hydroxyurea must be discontinued 24 hours prior to Gemtuzumab Ozogamicin administration.)
- Known active central nervous system (CNS) or testicular leukemia at time of study entry.
- Prior therapy with anti-CD33 antibodies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Little Rock, Arkansas, 72211, United States
Unknown Facility
Hartford, Connecticut, 06102, United States
Unknown Facility
Jacksonville, Florida, 32209, United States
Unknown Facility
Honolulu, Hawaii, 96813, United States
Unknown Facility
Olathe, Kansas, 66061, United States
Unknown Facility
Camden, New Jersey, 08103, United States
Unknown Facility
Trenton, New Jersey, 08629, United States
Unknown Facility
Buffalo, New York, 14215, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Canton, Ohio, 44708, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Charleston, West Virginia, 25304, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 4, 2002
First Posted
September 6, 2002
Study Start
March 1, 2000
Study Completion
September 1, 2004
Last Updated
May 18, 2006
Record last verified: 2006-05