The FDA recently approved a 90-minute infusion for rituximab (Rituxan) starting at cycle 2 for patients with non-Hodgkin lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during cycle 1. Patients with clinically significant cardiovascular disease and high circulating lymphocyte counts (≥ 5,000/µL) are not recommended to receive the faster infusion.
Phase III Trial
The approval was based on an open-label, single-arm, multicenter, phase III trial (RATE). The evaluable patient population was comprised of 363 previously untreated patients with follicular NHL or diffuse large B-cell lymphoma who had not experienced a grade 3 or 4 infusion-related reaction to rituximab in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or CVP (cyclophosphamide, vincristine, prednisone) chemotherapy during cycle 1. Patients received the faster infusion in cycle 2 and, if tolerated, in all subsequent cycles. The faster infusion regimen consisted of rituximab administered over 90 minutes with 20% of the total dose given in the first 30 minutes, and remaining 80% of the total dose administered over the subsequent 60 minutes.
The trial’s primary endpoint was the incidence of grade 3 and 4 infusion-related reactions in patients who received rituximab by faster infusion at cycle 2. The incidence of grade 3 infusion-related reactions at cycle 2 was 1.1% (95% CI = 0.3–2.8), with no grade 4 or 5 infusion-related reactions reported. The RATE trial results are comparable to the results of infusion-related reactions during cycle 2 reported from trials using the standard infusion regimen. ■