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Table 2 Ongoing key clinical trials in elderly or unfit patients with CLL

From: Therapeutic potential of new B cell-targeted agents in the treatment of elderly and unfit patients with chronic lymphocytic leukemia

Study Design Treatment Patients Primary outcome
NCT01722487 Phase 3, randomized, multicenter, open-label (RESONATE-2) Ibrutinib vs chlorambucil Frontline CLL/SLL, ≥65 years PFS
NCT01886872 Phase 3, randomized, multicenter, open-label Ibrutinib vs ibrutinib + rituximab vs bendamustine + rituximab Frontline CLL, ≥65 years PFS
NCT01203930 Phase 2, single-arm, multicenter, open-label Idelalisib or idelalisib + rituximab Frontline CLL/SLL, ≥65 years OR
NCT00645606 Phase 3, randomized, multicenter, open-label Rituximab vs observation as maintenance after FCR Frontline CLL, >65 years PFS
NCT01263704 Phase 2, single-arm, multicenter, open-label Rituximab + low dose fludarabine + cyclophosphamide Frontline CLL, ≥65 years OR
NCT01832922 Phase 1, nonrandomized, multicenter, open-label, dose-ranging Bendamustine + rituximab CLL/SLL, multiple comorbidities ± renal insufficiency AEs, MTD
NCT02015208 Phase 1/2, single-center, single-arm, open-label Ruxolitinib Frontline CLL, ≥65 years or ≥18 years with 17p deletion OR
NCT01444716 Phase 2, single-center, single-arm, open-label Ofatumumab Frontline CLL, ≥65 years, unfit OR
NCT01809847 Phase 2, multicenter, single-arm, open-label Ofatumumab + dexamethasone (induction) and ofatumumab (maintenance) Poor-risk CLL, >55 years OR, rate of MRD-negative status
  1. AE adverse event, CLL chronic lymphocytic leukemia, CR complete response, FCR fludarabine, cyclophosphamide, rituximab, MRD minimum residual disease, MTD maximum tolerated dose, OR overall response, OS overall survival, PFS progression-free survival, PS performance status, SLL small lymphocytic lymphoma