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

History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years; patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)

Patients with active unstable angina, concomitant clinically significant active arrhythmias, myocardial infarction within 6 months, or congestive heart failure New York Heart Association class III-IV; patients with a cardiac ejection fraction (as measured by either multi gated acquisition scan \[MUGA\] or echocardiogram) \< 40% are excluded

Known evidence of active cerebral/meningeal disease; patients may have history of central nervous system (CNS) leukemic involvement if definitively treated with prior therapy and no evidence of active disease (defined as \>= 2 consecutive spinal fluid assessments with no evidence of disease) at that time of registration

Previous treatment with any anti-CD22 directed therapy

Patients with previous allogeneic stem cell transplant (SCT) if they meet either of the following criteria:

* \< 100 days from allogeneic SCT

* Active acute or chronic graft-versus-host disease (GvHD), or

* Receiving immunosuppressive therapy as treatment for GvHD within the last 7 days

Active hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)

Patients with liver cirrhosis or other serious active liver disease or with suspected alcohol abuse

History of autoimmune diseases (such as systemic lupus erythematosus \[SLE\], Wegener's, Wegener's granulomatosis, polyarteritis nodosa); Note: Prior autoimmune diseases are allowed as long as clinically stable

Prior chemotherapy/radiotherapy/investigational therapy within 2 weeks before the start of study drugs with the following exceptions:

* To reduce the circulating lymphoblast count or palliation: steroids, hydroxyurea; no washout necessary for these agents

* For ALL maintenance/CML treatment: mercaptopurine, methotrexate, vincristine, single-agent, single-dose of cytarabine and/or tyrosine kinase inhibitors; these agents should be discontinued at least 48 hours prior to start of study drugs; (Note: the interval of time from last dose of any approved tyrosine kinase inhibitor \[TKI\] to start of protocol treatment is 48 hours regardless of the indication for treatment with the TKI)

Patients who have not recovered from acute non hematologic toxicity (to =\< grade 1) of all previous therapy prior to enrollment

Females who are pregnant or lactating

Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study

Patients previously exposed to bosutinib are eligible unless they carry T315I

Patients with T315I mutations will be excluded (this criteria is not applicable for the frontline Ph+ ALL or CML-LBC cohort)

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

What this study is about

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

What this study is about