At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 78 enrolled

Drug / intervention

All-Trans Retinoic Acid (ATRA) +3 moredrug

Likely dose

All-Trans Retinoic Acid (ATRA) 45 mg/m2from 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/NCT00413166

NCT00413166Phase 2Completed

Compare CT.gov

Treatment of Acute Promyelocytic Leukemia (APL) With All-Trans Retinoic Acid, and Arsenic +/- Idarubicin

M.D. Anderson Cancer Center·interventional·Posted Dec 19, 2006·Updated May 7, 2019

In Brief

A Phase 2 clinical trial evaluating All-Trans Retinoic Acid (ATRA), Arsenic Trioxide (ATO), and 2 other interventions for Acute Promyelocytic Leukemia. Completed, enrolled 78 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if the combination of arsenic trioxide (ATO) with ATRA and possibly idarubicin is effective in treating patients with newly-diagnosed APL.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcute Promyelocytic Leukemia

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2006

First PostedDec 2006

Primary CompletionFeb 2016

TodayJul 2026

First PostedDec 19, 2006

Enrollment StartDec 1, 2006

Primary CompletionFeb 1, 2016

TodayJul 2, 2026

Enrollment to primary: 9.2 yearsPosted 19.5 years ago

Interventions

All-Trans Retinoic Acid (ATRA)drug

Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1

Arsenic Trioxide (ATO)drug

Induction: 0.15 mg/kg daily IV beginning day 1

Idarubicindrug

1. 12 mg/m2 one dose only (may be given on day 1 to 5 of induction) 2. If either ATRA or ATO are discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses will be administered once every 4 to 5 weeks (depending on the recovery of counts) until 28 weeks has elapsed from the Complete Recovery date.

Gemtuzumab Ozogamicindrug

Induction: 9 mg/m2 on day 1 of induction