CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Azacitidine +2 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/NCT01892371
NCT01892371Phase 2Completed

Phase I/II Study of the Combination of Quizartinib (AC220) With 5-Azacytidine or Low-Dose Cytarabine for the Treatment of Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

M.D. Anderson Cancer Center·interventional·Posted Jul 4, 2013·Updated Apr 6, 2025

In Brief

A Phase 2 clinical trial evaluating Azacitidine, Cytarabine, and 1 other intervention for FLT3 Gene Mutation Negative and 7 related conditions. Completed, enrolled 73 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and best dose of quizartinib when given in combination with azacitidine or cytarabine in treating patients with acute myeloid leukemia or myelodysplastic syndrome that have come back (relapsed) or are not responding to treatment (refractory). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine and cytarabine 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 quizartinib with azacitidine or cytarabine may work better in patients with acute myeloid leukemia or myelodysplastic syndrome.

Study Details

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 4, 2013
Enrollment StartNov 12, 2013
Primary CompletionFeb 7, 2023
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 13.0 years ago

Interventions

Azacitidinedrug

Given SC or IV

Cytarabinedrug

Given SC

Quizartinibdrug

Given PO