Table 1. Basic characteristics of included randomized trials.
| Trial Name Registration Code Year | Study Design | Treatment Design | Cases | Mean Age | Follow up/Analysis | Front-line cases(%)/FCR regimen(%) | CR/PR(%) | Front-line regimens | |
|---|---|---|---|---|---|---|---|---|---|
| CONTINUUM (NCT00774345) 2017 | Phase III, DB, MC, RCT | Lenalidomide v.s. Placebo | Oral 2.5 mg/day (if tolerated, maximal escalated to 5 mg/day) | 160 v.s. 154 | 63.0 v.s. 63.0 | 31.5 months (18.9–50.8) ITT | 28%/98.9% | 23.90%/76.10% | FCR, chlorambucil, alemtuzumab |
| CLLM1 (NCT01556776) 2017 | Phase III, DB, MC, RCT | Lenalidomide v.s. Placebo | Oral 5 mg/day (if tolerated, maximal escalated to 15 mg/day) | 60 v.s. 29 | 64.0 v.s. 64.0 | 17.9 months (9.1–28.1) ITT | 100%/22.1% | 39.30%/60.70% | FCRB |
| CLL 2007 SA (NCT00645606) 2017 | Phase III, OP, MC, RCT | Rituximab v.s. Observation | Intravenous 500 mg/m2 2-monthly intervals for 2 years (maximum of 12 cycles) | 202 v.s. 207 | 71.7 v.s. 71.1 | 47.9 months (32.4–65.1) ITT | 100%/100% | 36.7%/73.30% | FCR |
| AGMT CLL-8a (NCT01118234) 2016 | Phase III, OP, MC, RCT | Rituximab v.s. Observation | Intravenous 375 mg/m2 3-monthly intervals for 2 years | 134 v.s. 129 | 63.0 v.s. 63.0 | 33.4 months (25.7–42.8) ITT | 79.8%/91.9% | 56.3%/43.7% | FCRB |
| PALG-CLL4 (NA) 2018 | Phase III, OP, MC, RCT | Rituximab v.s. Observation | Intravenous 375 mg/m2 3-monthly intervals for 2 years | 33 v.s. 33 | 57.8 v.s. 57.3 | NA (Prematurely terminated) ITT | 100%/0% | 22.7%/50.5% | RCC |
| PROLONG (NCT00802737) 2015 | Phase III, OP, MC, RCT | Ofatumumab v.s. Observation | Intravenous first dose of 300 mg, increased to 1000mg next week, then 2-monthly intervals for 2 years | 238 v.s. 236 | 64.0 v.s. 65.0 | 19.1 months (10.3–28.8) ITT | Only enrolled received second-line/42.8% | 19.20%/80.80% | FCR, FR, BR, R-CVP, Alkylating monotherapy |
CR: Complete response, PR: Partial response, OP: Open label; DB: double blind, MC: Multiple centers, RCT: randomized controlled trial, ITT: intention-to-treat,
RCC: Rituximab, Cladribine and Cyclophosphamide, FCR: Fludarabine, Cyclophosphamide and Rituximab, FR: Fludarabine and Rituximab, BR: Bendamustine and Rituximab, R-CVP: Bendamustine, Cyclophosphamide, Vincristine and Predisone, FCRB: Fludarabine, Cyclophosphamide, Rituximab and Bendamustine