CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Cytarabine +4 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.

Search/NCT01729845
NCT01729845Phase 2Completed

Mitoxantrone, Etoposide, and Cytarabine (MEC) Following Epigenetic Priming With Decitabine in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS): A Phase 1/2 Study

Fred Hutchinson Cancer Center·interventional·Posted Nov 20, 2012·Updated Feb 7, 2019

In Brief

A Phase 2 clinical trial evaluating Cytarabine, Decitabine, and 3 other interventions for Previously Treated Myelodysplastic Syndrome and Recurrent Adult Acute Myeloid Leukemia. Completed, enrolled 52 participants across 3 sites.

Detailed Summary

This phase I/II trial studies the side effects and best dose of decitabine followed by mitoxantrone hydrochloride, etoposide, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has returned after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as mitoxantrone hydrochloride, etoposide, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 20, 2012
Enrollment StartDec 20, 2012
Primary CompletionAug 25, 2016
Study CompletionApr 3, 2017
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.6 years ago

Interventions

Cytarabinedrug

Given IV

Decitabinedrug

Given IV

Etoposidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mitoxantrone Hydrochloridedrug

Given IV