NCT02311998

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

A Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-Positive Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia and Chronic Myeloid Leukemia Lymphoid Blast Phase

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study and whether or not you have received earlier treatment for leukemia. Up to 36 participants will be enrolled in Part 1 of the study, and up to 44 participants will be enrolled in Part 2. If you are enrolled in Part 2, you will receive bosutinib at the highest dose that was tolerated in Part 1. All participants in Parts 1 and 2 will receive the same dose of inotuzumab ozogamicin. Study Drug Administration. You will take bosutinib tablets by mouth 1 time each day with food. If you miss or vomit a dose of bosutinib, do not take "make up" the dose. Wait and take your next dose as scheduled the next day. You will also receive inotuzumab ozogamicin by vein over about 1 hour on Days 1, 8, and 15 of each 28-day cycle. If the doctor thinks it is needed, you may switch to a different dosing schedule and receive inotuzumab ozogamicin 1 time every 4 weeks. You will be given standard drugs (such as acetaminophen/paracetamol, antihistamines, and/or steroids) to help decrease the risk of side effects. If your doctor thinks it is needed, you may also receive hydroxyurea to control your white blood cell count while you are on study. You may ask the study staff for information about how these drugs are given and their risks. Follow-Up After your end-of-treatment visit or call, you will be called 1 time about every 12 weeks (for up to 1 year) and asked about any anti-cancer therapy you may have started. This call will last about 5 minutes. After completion of study treatment, patients are followed up every 12 weeks for up to 1 year.

Conditions

• B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
• Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Blasts More Than 5 Percent of Bone Marrow Nucleated Cells
• CD22 Positive
• Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia
• Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Interventions

Type	Name	Description
DRUG	Bosutinib	Given PO
BIOLOGICAL	Inotuzumab Ozogamicin	Given IV

Timeline

• Start date: 2015-04-16
• Primary completion: 2022-03-23
• Completion: 2022-03-23
• First posted: 2014-12-09
• Last updated: 2023-07-17
• Results posted: 2023-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study