Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"
Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia
Maria Sklodowska-Curie National Research Institute of Oncology
124 participants
Oct 5, 2021
INTERVENTIONAL
Conditions
Summary
A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria11
- Lymphoblastic lymphoma with bone marrow blasts\<20%.
- Patients with a history of chronic myeloid leukemia or other myeloproliferative disease.
- Major surgery within 4 weeks before enrollment.
- 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).
- Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus
- 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.
- 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
- Intolerance to treatment with monoclonal antibody.
- Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.
- Inability to obtain written informed consent.
- Inability to comply with regular monitoring.
Interventions
Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland. Patients in experimental arm will receive obinutuzumab .Obinutuzumab: 1000 mg i.v. (first infusion divided into 100 mg on d. 1 and 900 mg on d. 2).
Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland.The protocol includes the use of rituximab in combination chemotherapy. Rituximab: 375 mg/m2 intravenously (i.v.)
Locations(19)
View Full Details on ClinicalTrials.gov
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NCT04920968