NCT00413166View on ClinicalTrials.gov

All-trans Retinoic Acid, and Arsenic +/- Idarubicin

PHASE2CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions
Acute Promyelocytic Leukemia
Interventions
DRUG

All-Trans Retinoic Acid (ATRA)

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

DRUG

Arsenic Trioxide (ATO)

Induction: 0.15 mg/kg daily IV beginning day 1

DRUG

Idarubicin

"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."

DRUG

Gemtuzumab Ozogamicin

Induction: 9 mg/m2 on day 1 of induction

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT00413166 - All-trans Retinoic Acid, and Arsenic +/- Idarubicin | Biotech Hunter | Biotech Hunter