Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"

Korábbi kezelés

• 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.

Más betegség

• Patients with a history of chronic myeloid leukemia or other myeloproliferative disease.
• Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus

Laborértékek

• Impaired cardiac function: ejection fraction <40% on echocardiography, QTc interval > 450 ms on baseline electrocardiogram. 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 of the laboratory, total bilirubin> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase > 5 upper normal limit, unless related to Acute lymphoblastic leukemia

Életkor

• Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.

Egyéb

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

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