Efficacy and safety of obinutuzumab versus rituximab in combination with chemotherapy for adult patients with newly diagnosed CD20-positive acute lymphoblastic leukemia

Prior treatment

• Major surgery within 4 weeks before enrollment
• Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
• Intolerance to treatment with monoclonal antibody.

Other illness

• Patients with a history of chronic myeloid leukemia or other myeloproliferative disease
• Active infection e.g. HBV, HCV, HIV

Lab values

• Impaired cardiac function: ejection fraction <40% on echocardiography, QTc interval >450 ms on baseline ECG. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
• Serum creatinine >2 times the upper normal limit (UNL) of the laboratory, total bilirubin> 2.5 UNL unless related to ALL, AST or ALT >5 UNL, unless related to ALL

Age

• Positive pregnancy test (β-HCG) for women of childbearing age

Other

• Lymphoblastic lymphoma with bone marrow blasts <20%.
• Inability to obtain written informed consent
• Inability to comply with regular monitoring.

• Age ≥18 years.
• Newly diagnosed ALL with CD20 expression on at least 20% of blasts
• Signed written informed consent.
• Adequate contraception in case of women with child-bearing potential.