Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02401503 | Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG) | PHASE2 | COMPLETED | 66 | — | — | May 6, 2015 | Dec 17, 2024 | Jun 10, 2025 | 1 | Germany |
Proportion of patients responding according to international working Group on chronic lymphocytic leukemia criteria
| Arm | Type | Description |
|---|---|---|
| Bendamustine + GA101 + ABT-199 | EXPERIMENTAL | Bendamustine: 70mg/m² i.v. GA101: 1000 mg i.v. ABT-199: 20 - 400 mg p.o. Possible Re-treatment of the included patients with GA101: 1000 mg i.v. and ABT-199: 20 - 400 mg p.o. |
| Name | Type | Description |
|---|---|---|
| Bendamustine | DRUG | Debulking: Cycles 1-2, d1 \& 2: 70mg/m² i.v. |
| GA101 | DRUG | Induction: Cycle 1: d1: 100mg, d1(or 2): 900mg, d8 \& 15: 1000mg; Cycle 2-6: d1: 1000mg Maintenance: Cycles 1-8 (Duration 12 weeks): d1: 1000mg |
| ABT-199 | DRUG | Induction: Cycle 2: d1-7: 20mg, d8-14: 50mg, d15-21: 100mg, d22-28: 200mg; Cycle 3-6: d1-28: 400mg Maintenance: Cycles 1-8 (Duration 12 weeks): d1-84: 400mg |
Inclusion Criteria: * documented chronic lymphocytic leukemia (CLL) requiring treatment according to International Working Group on CLL (iwCLL) criteria * adequate renal function: a creatinine clearance ≥30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measur...