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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

September 26, 2014

Study Completion Date

September 26, 2014

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

5-Azacitidine

Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit.

DRUG

Gemtuzumab ozogamicin

Mylotarg given 2 times over 2 weeks

Trial Locations (3)

30342

Northside Hospital/BMTGA, Atlanta

92093

UCSD Moores Cancer Center, La Jolla

94305

Stanford University, Stanford

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Pfizer

INDUSTRY

lead

University of California, San Diego

OTHER