A study of rituximab and ifosfamide, carboplatin, and etoposide chemotherapy in children with recurrent/refractory B-cell (CD20+) non-Hodgkin lymphoma and mature B-cell acute lymphoblastic leukemia: a report from the Children's Oncology Group.

BACKGROUND: To estimate the response rate and therapy related toxicities of the anti-CD20 monoclonal antibody rituximab when combined with chemotherapy including ifosfamide, carboplatin, and etoposide (ICE) in patients with relapsed and refractory B-cell non-Hodgkin lymphoma and mature B-cell acute lymphoblastic leukemia (B-ALL).

METHODS: Patients received rituximab and ICE for 1-3 cycles, depending upon response. Rituximab (375 mg/m(2)) was given on day 1 and 3 of each cycle (day 1 only for cycle 3), with ifosfamide (3,000 mg/m(2)) and etoposide (100 mg/m(2)) given on days 3, 4, and 5 and carboplatin (635 mg/m(2)) given on day 3 only.

RESULTS: Twenty-one patients were enrolled, of whom 20 were eligible and evaluable. Although hematologic toxicities were common, only one patient was removed from study due to prolonged myelosuppression. Toxicities related to infusions of rituximab were frequent but manageable. Of the six eligible patients with diffuse large B-cell lymphoma, three achieved complete remission (CR), one had stable disease (SD), and two had progressive disease (PD). Of the 14 eligible patients with Burkitt lymphoma and B-ALL, there were four complete responses (CR), five partial responses (PR), one SD, and four with PD. Thus, the CR/PR rate for the entire group was 12/20 (60%). Following completion of protocol therapy six patients were able to proceed to consolidation with high-dose therapy and stem cell rescue.

CONCLUSIONS: The combination of rituximab and ICE chemotherapy was associated with an encouraging objective response (OR) rate and an acceptable toxicity profile.