Status:
RECRUITING
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Promyelocytic Leukemia With PML-RARA
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used ...
Detailed Description
PRIMARY OBJECTIVES: I. Assess whether a combination of all-trans retinoic acid (ATRA \[tretinoin\]), and arsenic trioxide (ATO) can produce long-term event-free survival in patients with low-risk unt...
Eligibility Criteria
Inclusion
- A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test
- Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study
- Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and/or one dose of idarubicin due to the urgency to start therapy early)
- Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug
- All sexually active subjects (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the study
Exclusion
- Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds
- Patients with creatinine \> 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
- Patients with total bilirubin \>= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
- Patients with alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \> 3 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Key Trial Info
Start Date :
October 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 18 2027
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01409161
Start Date
October 5 2011
End Date
December 18 2027
Last Update
December 17 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
2
MD Anderson Regional Care Center-Katy
Houston, Texas, United States, 77094
3
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, United States, 77058
4
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, United States, 77478