Beschreibung

Rekrutierung gestartet

PHASE III RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE IN COMPARISON TO RITUXIMAB IN COMBINATION WITH LENALIDOMIDE IN PATIENTS WITH INDOLENT NON-HODGKIN’S LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPY

Studientherapie

M+Len Arm
Mosunetuzumab
Mosunetuzumab will be administered intravenously in a setting with immediate access to
trained critical care personnel and facilities equipped to respond to and manage medical
emergencies. Mosunetuzumab will be administered in a step-up dosing schedule. In
Cycle 1 (21-day cycle), patients will receive 1 mg on Day 1; 2 mg on Day 8; and 30 mg
on Day 15. In Cycle 2-12 (28-day cycle), patients will receive 30 mg on Day 1. See
Figure 2 for dosing regimen.
Initially, mosunetuzumab will be infused over 4 hours (±15 minutes). The infusion may
be slowed or interrupted for patients experiencing infusion-associated symptoms.
Following each mosunetuzumab dose, patients will be observed at least 90 minutes for
fever, chills, rigors, hypotension, nausea, or other signs and symptoms of CRS. In the
absence of infusion-related adverse events, the infusion time of mosunetuzumab in
Cycles 2 and beyond may be reduced to 2 hours (±15 minutes). Patients who receive
the Mosun + Len combination do not require hospitalization. Although, hospitalization is
not mandated, the investigator should actively assess the need for hospitalization, and
patients should be hospitalized whenever clinically indicated. The hospitalization
requirement may be modified based on iDMC recommendation after review of the
emerging safety profile of study treatment.
Lenalidomide
Lenalidomide will be administered PO once daily on Days 1-21 of Cycles 2-12
(28-day cycles) at a dose of 20 mg. See Figure 2 for dosing regimen.
Tocilizumab
Tocilizumab will not be administered to all patients but only to those patients who
experience a CRS event for which tocilizumab is indicated (a rescue IMP). Tocilizumab
will be supplied by the Sponsor. Refer to the local prescribing information for further
instructions regarding recommended storage conditions and packaging configuration.
For patients requiring treatment of CRS, patients will receive tocilizumab by IV infusion.
Patients who weigh
30 kg will receive 8 mg/kg tocilizumab and patients who weigh
<30 kg will receive 12 mg/kg tocilizumab. Doses exceeding 800 mg per infusion are not
recommended. Treatment may be repeated every 8 hours as necessary (for a maximum of four doses).
R+Len Arm
Rituximab
Rituximab must be administered in a clinic or hospital equipped for systemic (IV)
cancer treatment. Full emergency resuscitation facilities should be immediately
available, and patients should be under close observation by the investigator at all
times. In case of infusion-associated adverse events in patients, the signs and
symptoms should be fully resolved before the patient is discharged. 375 mg/m2
rituximab will be administered to patients by IV infusion on D1, 8, 15, and 22 of C1,
followed by administration on D1 of Cycles 3, 5, 7, 9, 11 of 28-day cycles. See Figure 3
for dosing regimen.
Lenalidomide
Lenalidomide will be administered PO once daily on Days 1-21 of Cycles 1-12 (28-day cycles) at a dose of 20 mg. See Figure 3 for dosing regimen.