Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)

1. Isolated extramedullary disease.

2. Burkitt's or mixed-lineage leukemia.

3. Active central nervous system (CNS) leukemia.

4. Any prior therapy for ALL except for limited treatment (≤ 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal therapy. Patients who are being treated with chronic steroids for other reasons (eg, asthma, autoimmune disorders) are eligible.

5. Current or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen and anti-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV). HIV testing may need to be performed in accordance with local regulations or local practice. Patients with HIV but an undetectable viral load are eligible for enrollment

6. Major surgery within ≤ 2 weeks before randomization.

7. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function or unstable pulmonary condition.

8. Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been definitely treated with radiation or surgery. Patients with previous malignancies are eligible provided that they have been disease free for ≥2 years or are not currently requiring treatment.

9. Uncontrolled cardiac disease.

10. QTcF \> 500 msec (based on the average of 3 consecutive ECGs).

11. History of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.

12. History of hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).

13. Evidence of uncontrolled current serious active infection including sepsis, bacteremia, fungemia, or patients with a recent history (within 4 months) of deep tissue infections such as fasciitis or osteomyelitis.

14. Medications known to predispose to Torsades de Pointes are prohibited throughout the treatment period of the study.

15. Pregnant females; breastfeeding females; males with female partners of reproductive potential and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for a minimum of 5 months after the last dose of investigational product if male and 8 months after the last dose of investigational product if female.

16. Patients who are investigational site staff members or relatives of those site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.

17. Participation in other investigational studies during active treatment phase.

18. Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Study Lead Principal Investigator, would make the patient inappropriate for entry into this study.

What this study is about