Acute Promyelocytic Leukemia (APL) Treated With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin
The goal of this clinical research study is to learn if the combination of all-trans retinoic acid (ATRA), arsenic trioxide (ATO), and gemtuzumab ozogamicin (GO) can help to control APL. The safety of this drug combination will also be studied.
Drug: GO (Gemtuzumab ozogamicin)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)|
- Event Free Survival (EFS) [ Time Frame: Day 21-28 ] [ Designated as safety issue: No ]Time from start of treatment to first documentation of disease relapse or death. For each risk group, Bayesian time-to-event model used to monitor the event free survival (EFS) time.
|Study Start Date:||October 2011|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: ATRA + ATO
Induction: All-trans retinoic acid (ATRA) 45 mg/m2 daily orally and Arsenic trioxide (ATO) 0.15 mg/kg by vein daily beginning on day 1 with Gemtuzumab ozogamicin (GO) 9 mg/m2 by vein. Methylprednisolone 50 mg by vein daily for 5 days followed by rapid taper starting on day 6 (Induction).
45 mg/m2 daily by mouth beginning Day 1 (in 2 divided doses approximately 12 hours apart) for Course 1 (Induction) and during Weeks 1-2 and 5-6 of Courses 2-5 (Consolidation).
Other Names:Drug: ATO
0.15 mg/kg by vein over 1 hour (+/- 10 minutes) daily beginning on day 1, Course 1 (Induction) then over 1-2 hours for 5 days total during Weeks 1-4 of Courses 2-5 (Consolidation). Each course is about 8 weeks.
Other Names:Drug: GO (Gemtuzumab ozogamicin)
9 mg/m2 by vein may be given one time during weeks 1-4 (Induction).
Other Names:Drug: Methylprednisolone
50 mg by vein daily for 5 days followed by rapid taper starting on day 6 (Induction).
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409161
|Contact: Farhad Ravandi-Kashani, MD||713-745-0394|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Farhad Ravandi-Kashani, MD||M.D. Anderson Cancer Center|