At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 52 enrolled
Drug / intervention
vorinostat +2 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 1/2 Study of Vorinostat (Zolinza®) in Combination With Gemtuzumab Ozogamicin (Mylotarg®) and Azacitidine (Vidaza®) in Patients 50 Years of Age and Older With Relapsed/Refractory Non-APL Acute Myeloid Leukemia (AML)
In Brief
A Phase 2 clinical trial evaluating vorinostat, gemtuzumab ozogamicin, and 1 other intervention for Adult Acute Megakaryoblastic Leukemia (M7) and 13 related conditions. Completed, enrolled 52 participants across 4 sites.
Detailed Summary
The purpose of this study is to test the safety of vorinostat (Zolinza) and azacitidine (Vidaza) when combined with gemtuzumab ozogamicin (GO) at different dose levels. These drugs increase the effect of GO against leukemia cells in the test tube, but we don't know yet whether they also increase the anti-leukemia effect of GO in people.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Recurrent Adult Acute Myeloid Leukemia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedMay 2009
Primary CompletionJul 2013
Study CompletionSep 2013
TodayJul 2026
First PostedMay 8, 2009
Enrollment StartMay 1, 2009
Primary CompletionJul 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 17.2 years ago
Interventions
vorinostatdrug
Given orally
gemtuzumab ozogamicindrug
Given intravenously (IV)
azacitidinedrug
Given IV or subcutaneously (SC)