116
Participants
Start Date
April 19, 2024
Primary Completion Date
December 31, 2027
Study Completion Date
March 31, 2028
rituximab
"Rituximab will be administered intravenously in three courses. The 1st course (loading dose) will include six rituximab infusions on days 1, 3, 5, 8, 14, and 21 of the study. On days 1, 3, and 5 rituximab will be infused at doses of 50, 125, and 200 mg per m2 of the participant's body surface area, respectively. On days 8, 14, and 21 rituximab will be infused at doses of 375 mg/m2, but not more than 500 mg total dose.~The 2nd course (maintenance therapy) will include four rituximab infusions on days 63, 70, 77, and 85 at doses of 375 mg/m2, but not more than 500 mg total dose.~The 3rd course (maintenance therapy) will include four rituximab infusions on days 119, 126, 134, and 140 at doses of 375 mg/m2, but not more than 500 mg total dose"
RECRUITING
I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow
RECRUITING
Russian Children's Clinical Hospital, Pirogov Russian National Research Medical University, Moscow
Pirogov Russian National Research Medical University
OTHER