Phase 2 N=50 Treatment

Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00766116 ↗

Enrolled (actual)

Serious AEs

40.0%

Results posted

Feb 2019

Primary outcome: Primary: Number of Participants With Dose Limiting Toxicities — 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 5-Azacitidine (Drug); Gemtuzumab ozogamicin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Sep 2014

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	—

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.

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

View full record on ClinicalTrials.gov →

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.