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. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a chemotherapy drug called ozogamicin. Gemtuzumab attaches to CD33 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill more cancer cells.
Additional locations may be listed on ClinicalTrials.gov for NCT01409161.
Locations matching your search criteria
United States
Texas
Conroe
MD Anderson in The WoodlandsStatus: Active
Contact: Farhad Ravandi-Kashani
Phone: 713-745-0394
Houston
MD Anderson West HoustonStatus: Active
Contact: Farhad Ravandi-Kashani
Phone: 713-745-0394
M D Anderson Cancer CenterStatus: Active
Contact: Farhad Ravandi-Kashani
Phone: 713-745-0394
League City
MD Anderson League CityStatus: Active
Contact: Farhad Ravandi-Kashani
Phone: 713-745-0394
Sugar Land
MD Anderson in Sugar LandStatus: Active
Contact: Farhad Ravandi-Kashani
Phone: 713-745-0394
PRIMARY OBJECTIVES:
I. Assess whether a combination of tretinoin (all-trans retinoic acid [ATRA]), 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:
INDUCTION: Patients receive tretinoin orally (PO) twice daily (BID), arsenic trioxide intravenously (IV) over 1-2 hours daily, and gemtuzumab ozogamicin IV over 2 hours once at weeks 1-4.
CONSOLIDATION: Patients achieving CR receive arsenic trioxide IV 5 days per week during weeks 1-4, 9-12, 17-20, and 25-28 and tretinoin PO BID for 2 weeks on and 2 weeks off. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Patients also undergo bone marrow biopsy and/or aspiration throughout the study.
After completion of study treatment, patients are followed up at 12, 18, and 24 months.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorFarhad Ravandi-Kashani
