drugset / Trial / NCT01409161
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Phase 2
Recruiting
151 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |