Wednesday, December 11, 2019 This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and rituximab with or without lenalidomide or cyclophosphamide work in treating patients with symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving fludarabine phosphate and rituximab together with lenalidomide or cyclophosphamide may be an effective treatment for chronic lymphocytic leukemia. Byrd JC, Ruppert AS, Heerema NA, Halvorson AE, Hoke E, Smith MR, Godwin JE, Couban S, Fehniger TA, Thirman MJ, Tallman MS, Appelbaum FR, Stone RM, Robinson S, Chang JE, Mandrekar SJ, Larson RA. Lenalidomide consolidation benefits patients with CLL receiving chemoimmunotherapy: results for CALGB 10404 (Alliance). Blood Adv 2: 1705-18, 2018. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6058242/ A total of 418 patients enrolled on this study between March 2008 and August 2012. As depicted in the CONSORT diagram (Figure 1), 400 patients are included in this analysis. Of the 18 patients not included, 7 never started treatment, 2 were ineligible, 1 withdrew consent for use of all data, and 8 with del(11q) had no reassignment to arm D (they were assigned to arm A or B prior to an amendment adding arm D). In addition, 15 patients did not have interphase cytogenetics results; a sample was not received by the central laboratory in 12, and a FISH result was not obtained in 3. These patients were included in the analysis within the arms to which they were initially randomized. Thus, central assignment of treatment by interphase cytogenetics by the second cycle of therapy was feasible in 385 patients (96%).
