drugset / Trial / NCT01925131
S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia
Non-randomizedSequentialOpen-labelTreatment
Summary
This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may kill more cancer cells.
Timeline
- Start
- 2014-06-13
- Primary completion
- 2022-01-01
- Completion
- 2023-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 0.4 mg/m2 | Intravenous |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 0.5 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Vincristine | Small molecule | — | Intravenous |