drugset / Trial / NCT02311998

Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML

NCT02311998

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of bosutinib when given together with inotuzumab ozogamicin and to see how well it works in treating patients with acute lymphoblastic leukemia or chronic myeloid leukemia that has come back or does not respond to treatment. Bosutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells. Giving bosutinib together with inotuzumab ozogamicin may be a better treatment for acute lymphoblastic leukemia or chronic myeloid leukemia.

Timeline

Start
2015-04-16
Primary completion
2022-03-23
Completion
2022-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Bosutinib Small molecule Oral
Subject Inotuzumab Ozogamicin Monoclonal antibody Intravenous