At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with APL with PML-RARA fusion gene by cytogenetics, PCR, or POD test
- ✓Able to understand and willing to sign informed consent
- ✓May have started ATRA, ATO, and/or one dose of idarubicin prior to enrollment due to emergent treatment needs
- ✓Women of childbearing potential must have negative serum pregnancy test at screening and within 48 hours prior to dosing
- ✕QTcF interval on EKG greater than 480 milliseconds
- ✕Creatinine > 2.5 times upper limit of normal unless related to underlying leukemia, hemolysis, or Gilbert's disease
- ✕Total bilirubin >= 2.0 times upper limit of normal unless related to underlying leukemia, hemolysis, or Gilbert's disease
- ✕ALT/AST > 3 times upper limit of normal unless related to underlying leukemia, hemolysis, or Gilbert's disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)
In Brief
A Phase 2 clinical trial evaluating Arsenic Trioxide, Gemtuzumab Ozogamicin, and 2 other interventions for Acute Promyelocytic Leukemia With PML-RARA. Currently recruiting, targeting 151 participants across 5 sites.
Signals
Detailed 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 in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotoxins, such as gemtuzumab ozogamicin, may find certain cancer cells and kill them without harming normal cells. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill more cancer cells.
Study Details
Timeline
Interventions
Given IV
Given IV
Correlative studies
Given PO