Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)
M.D. Anderson Cancer Center
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.
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 untreated acute promyelocytic leukemia (APL). II. Assess whether administration of gemtuzumab ozogamicin (GO) at the diagnosis in patients with high-risk APL (white blood cell \[WBC\] \> 10,000) and if the WBC rises to \> 10,000 after start of treatment (in patients with low-risk disease) will improve complete response (CR) rate without increasing toxicity in high-risk untreated APL. OUTLINE: INDU…
Eligibility
- Age range
- 10+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugArsenic Trioxide
Given IV
- DrugGemtuzumab Ozogamicin
Given IV
- OtherLaboratory Biomarker Analysis
Correlative studies
- DrugTretinoin
Given PO
Locations (5)
- M D Anderson Cancer CenterHouston, Texas
- MD Anderson Regional Care Center-KatyHouston, Texas
- MD Anderson Regional Care Center-Bay AreaNassau Bay, Texas
- MD Anderson Regional Care Center-Sugar LandSugar Land, Texas
- MD Anderson Regional Care Center-The WoodlandsThe Woodlands, Texas