Table 1.
Clinical trials in asymptomatic CLL patients.
| Trial | Trial Status | Phase | Setting | Interventions | N. of patients | PFS | OS |
|---|---|---|---|---|---|---|---|
| Ibrutinib versus placebo in patients with asymptomatic, treatment-naïve early stage Chronic Lymphocytic Leukemia (CLL): primary endpoint results of the phase 3 double-blind randomized CLL12 trial [54] | Active, not recruiting | 3 | Untreated patients with stage A CLL with intermediate, high or very high risk of progression | Ibrutinib | 182 | Median PFS: not reached at median observation time of 31 months | - |
| Placebo | 181 | Median PFS: 14.8 months | - | ||||
| Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia [53] | Completed | 3 | Untreated patients with stage A CLL aged 18 years or older | High Risk Patients - Fludarabine | 93 | Median PFS: 30.1 months | Median OS: 126.8 months |
| High Risk Patients - Watch & Wait | 96 | Median PFS: 12.9 months | Median OS: not reached at median observation time of 8.5 years | ||||
| Chlorambucil in Indolent Chronic Lymphocytic Leukemia [52] | Completed | 3 | Untreated patients with stage A CLL | No treatment | 308 | - | 5 years: 80% 10 years: 54% |
| Chlorambucil (0.1 mg/Kg/die) | 301 | - | 5 years: 76% 10 years: 47% |
||||
| Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia [59] | Completed | 3 | Untreated patients with stage A CLL aged 18 years or older | High Risk Patients- FCR | 100 | Median PFS: not reached at median observation time of 55.6 months 5 years PFS: 55.2% |
5 years: 82.9% |
| High Risk Patients- Watch & Wait | 101 | Median PFS: 18.6 5 years PFS: 12.6% |
5 years: 79.9% | ||||
| Low Risk Patients - Watch & Wait | 599 | Median PFS: 84.3 5 years PFS: 77.1% |
5 years: 97.2% | ||||
| Alemtuzumab and Rituximab in Treating Patients With High-Risk, Early-Stage Chronic Lymphocytic Leukemia [NCT00436904] | Completed | 2 | Untreated patients with high-risk Rai stage 0-II CLL aged 18 years or older | Alemtuzumab + Rituximab | 30 | - | - |
| Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia [NCT01649791] | Terminated | - | Untreated patients with high-risk Rai-stage 0-II CLL aged 18 years or older | Lenalidomide | 8 | - | - |
| Rituximab, Alemtuzumab, and GM-CSF As First-Line Therapy in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia [NCT00562328] | Completed | 2 | Untreated patients with high-risk Rai-stage 0-II CLL aged 18 years or older | Alemtuzumab + Rituximab + GM-CSF | 33 | - | - |
| Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) [NCT01243190] | Active, not recruiting | 2 | Untreated patients with high-risk Rai-stage 0-II CLL aged 18 years or older | Ofatumumab | 44 (Estimated Enrollment) | - | - |
| Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A [NCT03766763] | Recruiting | 2 | Untreated patients with high-risk Binet Stage A CLL aged 18 years or older | Venetoclax | 82 (Estimated Enrollment) | - | - |
OS: overall survival.