At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 42 enrolled
Drug / intervention
Temozolomidedrug
Likely dose
Temozolomide 100 mg/m2from 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.
Phase II Study of Two Distinct Tailored Temozolomide Regimens for Patients With Acute Myeloid Leukemia Age > 60 Years and Poor Risk/Refractory Disease
In Brief
A Phase 2 clinical trial evaluating Temozolomide for Leukemia, Myeloid. Completed, enrolled 42 participants across 1 site.
Detailed Summary
Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid
CountriesUnited States
CollaboratorsSchering-Plough
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedFeb 2008
Primary CompletionDec 2009
Study CompletionJan 2010
TodayJul 2026
First PostedFeb 8, 2008
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.4 years ago
Interventions
Temozolomidedrug
Priming, Group 2 only, 100 mg/m2/day temozolomide. Induction (both arms) 200 mg/m2/day temozolomide