Trials / Completed
CompletedNCT00044733
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (planned)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 0 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mylotarg (gemtuzumab ozogamicin) Injection |
Timeline
- Start date
- 2000-03-01
- Completion
- 2004-09-01
- First posted
- 2002-09-06
- Last updated
- 2006-05-18
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00044733. Inclusion in this directory is not an endorsement.