CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled
Drug / intervention
Idarubicin +2 moredrug
Likely dose
Idarubicin 12 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/NCT00656617
NCT00656617Phase 2Completed
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Phase II Study of Idarubicin, Cytarabine, and Vorinostat in Patients With High-Risk MDS and AML

M.D. Anderson Cancer Center·interventional·Posted Apr 11, 2008·Updated Mar 9, 2015

In Brief

A Phase 2 clinical trial evaluating Idarubicin, Cytarabine, and 1 other intervention for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). Completed, enrolled 106 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to find the highest safe dose of vorinostat that can be given in combination with idarubicin and ara-C for the treatment of AML and high-risk MDS. Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help to control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 11, 2008
Enrollment StartApr 1, 2008
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 18.2 years ago

Interventions

Idarubicindrug

12 mg/m\^2 IV over 1 hour daily for 3 days (days 4 to 6)

Cytarabinedrug

1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7)

Vorinostatdrug

Initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).