CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 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/NCT01806571
NCT01806571Phase 2Completed

A Phase II Study of Combination Daunorubicin and Cytarabine (Ara-c) and Nilotinib (Tasigna) (DATA) in Patients Newly Diagnosed With Acute Myeloid Leukemia and KIT Overexpression

Mayo Clinic·interventional·Posted Mar 7, 2013·Updated May 31, 2023

In Brief

A Phase 2 clinical trial evaluating Cytarabine, Daunorubicin Hydrochloride, and 3 other interventions for Untreated Adult Acute Myeloid Leukemia. Completed, enrolled 34 participants across 2 sites.

Detailed Summary

This phase II trial studies how well daunorubicin hydrochloride, cytarabine, and nilotinib work in treating patients newly diagnosed with acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride 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. Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving daunorubicin hydrochloride with cytarabine and nilotinib may kill more cancer cells.

Study Details

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

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2013
Enrollment StartMar 12, 2015
Primary CompletionJul 31, 2017
Study CompletionNov 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.3 years ago

Interventions

Cytarabinedrug

Given IV

Daunorubicin Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Nilotinibdrug

Given PO

Pharmacological Studyother

Correlative studies