Clinical trial · Interventional
Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia
A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)
NCT00304447CI-TRIAL-00002502completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events, to evaluate the effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelet recovery (CRp) at one-month post treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infusions, Intravenous | — | UNRESOLVED | — |
| Leukemia, Myelocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mylotarg | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.
Secondary outcomes (1)
- measure
- The effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelets recovery (CRp) at one-month post treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with CD33 positive, resistant or relapsed AML. * Patients \> 18 years of age. * ECOG performance status 0-2. Exclusion Criteria: * Fever (\>38), chills or hypotension (systolic BP\<105mmHg) in the 48 hours preceding therapy. * Use of corticosteroids, diphenhydramine or acetaminophen within 24 hours of enrollment. * Participation in any other Mylotarg® protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.