Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB 9712)

Abstract

Recent studies have suggested that rituximab has clinical activity and modulates antiapoptotic proteins associated with drug resistance in chronic lymphocytic leukemia (CLL). We performed a randomized phase 2 study to determine the efficacy, safety, and optimal administration schedule of rituximab with fludarabine in previously untreated CLL patients. Patients were randomized to receive either 6 monthly courses of fludarabine concurrently with rituximab followed 2 months later by 4 weekly doses of rituximab for consolidation therapy or sequential fludarabine alone followed 2 months later by rituximab consolidation therapy. A total

Rituximab therapy in malignant lymphoma

“…Dose escalation, achieved by a thriceweekly dosing schedule (Byrd et al, 2001), or higher weekly doses, 500-2250 mg/m 2 (O'Brien et al, 2001), is necessary to reach significant clinical activity, with a RR of respectively 45 and 36%, as a single agent. The concurrent administration of rituximab with fludarabine resulted in better results with a RR rate of 90%, with 47% CR (Byrd et al, 2003). Ongoing clinical studies are examining the use of rituximab associated with fludarabine and cyclophosphamide, which has shown great promise in a single-center phase II study (Keating et al, 2005;Wierda et al, 2005).…”

Rituximab‐induced interstitial lung disease

“…Sixteen cases of R-ILD, our 2 patients plus 14 others reported elsewhere, were reviewed and summarized in Table I [4][5][6][7][8][9][10][11][12]. The majority of patients had a diagnosis of NHL (75%) and were elderly (average age 65).…”

Chronic Lymphocytic Leukemia: Recent Advances in Diagnosis and Treatment

“…Single-agent rituximab has rather limited efficacy in CLL. Rituximab has been added to the fludarabine [47] and fludarabine plus cyclophosphamide (FCR) [48] regimens, as well as the pentostatin plus cyclophosphamide (PCR) regimen [49] (Table 1). The addition of rituximab to fludarabine (FR regimen) has been shown to produce higher overall and complete response rates [50], as well as longer disease-free and overall survival times in previously untreated CLL patients [51].…”