At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
5-Azacitidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
In Brief
A Phase 2 clinical trial evaluating 5-Azacitidine and Gemtuzumab ozogamicin for Acute Myeloid Leukemia. Completed, enrolled 50 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesUnited States
CollaboratorsCelgene Corporation, Pfizer
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
First PostedOct 2008
Primary CompletionSep 2014
TodayJul 2026
First PostedOct 3, 2008
Enrollment StartJul 1, 2005
Primary CompletionSep 26, 2014
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 17.7 years ago
Interventions
5-Azacitidinedrug
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.
Gemtuzumab ozogamicindrug
Mylotarg given 2 times over 2 weeks