CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Temozolomide +1 moredrug
Likely dose
Temozolomide 200 mgfrom 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.

Search/NCT01550224
NCT01550224Phase 2Completed
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Temozolomide Plus Vorinostat in Patients With Relapse/Refractory Acute Myeloid Leukemia (AML)

Steven E. Coutre·interventional·Posted Mar 9, 2012·Updated Aug 9, 2018

In Brief

A Phase 2 clinical trial evaluating Temozolomide and Vorinostat for Acute Myeloid Leukemia With 11q23-abnormality in Relapse. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The purpose of the study is to first determine if temozolomide plus vorinostat in combination can control relapsed or refractory acute myeloid leukemia (AML) and determine if this combination can be safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in combination and whether the treatment schedule is tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia With 11q23-abnormality in Relapse
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2012
Enrollment StartMay 1, 2013
Primary CompletionNov 17, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.3 years ago

Interventions

Temozolomidedrug

An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days.

Vorinostatdrug

A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day.