drugset / Trial / NCT03488225

Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia

NCT03488225

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well combination chemotherapy and inotuzumab ozogamicin work in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute lymphoblastic leukemia.

Timeline

Start
2018-03-28
Primary completion
2020-04-02
Completion
2020-04-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Cytarabine Small molecule Intrathecal
Subject Dexamethasone Small molecule Intravenous
Subject Doxorubicin Other / unclassified Intravenous
Subject Inotuzumab Ozogamicin Monoclonal antibody Intravenous
Subject MERCAPTOPURINE ANHYDROUS Small molecule Oral
Subject Methotrexate Small molecule Intrathecal
Subject Ofatumumab Monoclonal antibody Intravenous
Subject Prednisone Other / unclassified Oral
Subject Rituximab Monoclonal antibody Intravenous
Subject Vincristine Small molecule Intravenous
Background Leucovorin Small molecule Intravenous