CI

At a glance

ClinicalIndex Comparison Record
Phase 2Enrolling by Invitation· 80 target
Drug / intervention
Cytarabine +2 moredrug
Likely dose
Cytarabine 3gfrom 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/NCT03031249
NCT03031249Phase 2Enrolling by InvitationMonitorUpdated 13mo ago · Completion was 1mo ago
Slow Enrollment
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Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia

Institute of Hematology & Blood Diseases Hospital, China·interventional·Posted Jan 25, 2017·Updated May 30, 2025

In Brief

A Phase 2 clinical trial evaluating Cytarabine, all-trans retinoic acid, and 1 other intervention for AML. Currently enrolling by invitation, targeting 80 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed Summary

In this open-label, randomized, prospective clinical trial, nucleophosmin-1(NPM1) mutated acute myeloid leukemia (AML) patients who have reached CR are randomized into two groups.The control group receive high-dose cytarabine(HDAC) regimen while the experimental group receive high dose of cytarabine plus tretinoin(ATRA) and arsenic trioxide(ATO) treatment.The safety and efficacy of ATRA and ATO is evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAML
CountriesChina
Collaborators--

Timeline

Phase 2Enrolling by Invitation
201720182019202020212022202320242025202620272028
First PostedJan 25, 2017
Enrollment StartFeb 8, 2017
Primary CompletionMay 15, 2026
Study CompletionOct 15, 2027
TodayJul 1, 2026
Enrollment to primary: 9.3 yearsPosted 9.4 years ago

Interventions

Cytarabinedrug

Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.

all-trans retinoic aciddrug

ATRA at a dose of 30mg/㎡/d on day 1-14.

Arsenic Trioxidedrug

ATO at a dose of 10mg/d on day 1-14