Acute Promyelocytic Leukemia (APL) Treated With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin
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|ClinicalTrials.gov Identifier: NCT01409161|
Recruitment Status : Recruiting
First Posted : August 4, 2011
Last Update Posted : May 10, 2018
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
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 acute promyelocytic leukemia (APL). The safety of this drug combination will also be studied.
This is an investigational study. ATRA and ATO are FDA approved and commercially available. GO is not FDA approved or commercially available. At this time, it is being used for research purposes only.
Up to 150 patients will take part in the study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: ATRA Drug: ATO Drug: GO (Gemtuzumab ozogamicin) Drug: Methylprednisolone||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)|
|Actual Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
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).
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.
Drug: GO (Gemtuzumab ozogamicin)
9 mg/m2 by vein may be given one time during weeks 1-4 (Induction).
50 mg by vein daily for 5 days followed by rapid taper starting on day 6 (Induction).
- Event Free Survival (EFS) [ Time Frame: Day 21-28 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409161
|Contact: Kiran Naqvi, MD||713-745-5073|
|Contact: Clinical Research Operations UT MD Anderson||CR_Study_Registration@mdanderson.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Kiran Naqvi, MD||M.D. Anderson Cancer Center|