At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 27 enrolled
Drug / intervention
GTI-2040biological
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 II Simon Two-stage Multicenter Study and Pilot Pharmacodynamic Investigation of GTI 2040 in Combination With High Dose Cytarabine (HiDAC) in Refractory and Relapsed Acute Myeloid Leukemia (AML)
In Brief
A Phase 2 clinical trial evaluating GTI-2040 for Acute Myeloid Leukemia. Completed, enrolled 27 participants across 7 sites.
Detailed Summary
This is a Phase II trial conducted at multiple centers for evaluation of the pharmacodynamic activity and the overall response rate contributed by the combination agents of GTI-2040 and High Dose Cytarabine (HiDAC) in Refractory and Relapsed Acute Myeloid Leukemia (AML).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesUnited States
CollaboratorsOhio State University
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedNov 2007
Primary CompletionSep 2009
Study CompletionFeb 2010
TodayJul 2026
First PostedNov 29, 2007
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.6 years ago
Interventions
GTI-2040biological
GTI-2040 will be administered one day after HiDAC in the pilot PD study and one day before HiDAC in the Phase II study for a cycle. Those who achieve a complete remission (CR) will be permitted to receive one cycle of consolidation of GTI-2040 and HiDAC