Phase 2
Completed N=50
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
Source: ClinicalTrials.gov NCT00766116 ↗Enrolled (actual)
50
Serious AEs
40.0%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities — 0; 0; 0 Participants
Summary
This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities |
0; 0; 0 | — |
| SECONDARY Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine |
36 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Relapsed AML
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy > 3 months
- ≥ 18 years old
- Previously untreated for current AML relapse
- Adequate organ function
- Written informed consent
Exclusion Criteria
- Pregnant or breast-feeding women
- Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days
- Currently receiving another investigational drug
- Currently receiving other anti-cancer agents
- Uncontrolled infection
- HIV positive
- Received previous therapy with either Mylotarg or 5-azacitidine
Data sourced from ClinicalTrials.gov (NCT00766116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.