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Terminated
NCT04920968
Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"
Conditions: CD20-positive Acute Lymphoblastic Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 49
Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Location: Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Bialystok
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 Criteria
Inclusion Criteria:
1. Age ≥18 years.
2. Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.
3. Signed written informed consent.
4. Adequate contraception in case of women with child-bearing potential
Exclusion Criteria:
1. Lymphoblastic lymphoma with bone marrow blasts\ 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
8. Intolerance to treatment with monoclonal antibody.
9. Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.
10. Inability to obtain written informed consent.
11. Inability to comply with regular monitoring.
Source: ClinicalTrials.gov (NCT04920968). StuddyBuddy aggregates publicly available trial information.
