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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
124
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.)
Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.
Time frame: assessed between days 33-34 since start of Induction I
The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation.
Time frame: assessed between days 20-28 since start of last course of consolidation
complete remission rate after Induction I
Time frame: assessed between days 33-34 since start of Induction I
Overall complete remission
Time frame: in 24month follow up
Probability of overall survival
Time frame: in 24 month follow up
Probability of relapse-free survival
Time frame: in 24 month follow up
Probability of event-free survival
Time frame: in 24 month follow up
Cumulative incidence of relapse
Time frame: in 24 month follow up
Rate of adverse events
Time frame: in 24 month follow up
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