drugset / Trial / NCT01409161

Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

NCT01409161

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-10-05
Primary completion
2027-12-18
Completion
2027-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemtuzumab Ozogamicin Monoclonal antibody 6 mg/m2 Intravenous
Subject Gemtuzumab Ozogamicin Monoclonal antibody 9 mg/m2 Intravenous
Subject Tretinoin Small molecule 45 mg/m2 Oral
Subject arsenic trioxide Small molecule 0.15 mg/kg Intravenous