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

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