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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02445131 | Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG) | PHASE2 | COMPLETED | 48 | — | — | May 28, 2015 | Mar 9, 2022 | May 9, 2024 | 1 | Germany |
Proportion of patients responding according to international working Group on chronic lymphocytic leukemia criteria
| Arm | Type | Description |
|---|---|---|
| Bendamustine + GA101 + CAL-101 | EXPERIMENTAL | Bendamustine: 70 mg/m2 i.v. GA101: 1000 mg CAL-101: 150 mg p.o. |
| Name | Type | Description |
|---|---|---|
| Bendamustine | DRUG | Debulking: Cycles 1 - 2, d1 \& 2: 70 mg/m2 i.v. |
| GA101 | DRUG | Induction: Cycle 1: d1: 100mg, d1(or2): 900mg, d8 \& 15: 1000mg; Cycle 2-6: d1: 1000mg Maintenance: Cycle 1-8 (Duration 12 weeks): d1 1000 mg. |
| CAL-101 | DRUG | Induction: Cycle 2-6: d1-28: 150 mg p.o. Maintenance: Cycles 1-8 (Duration 12 weeks): d1-84 150 mg p.o. |
Inclusion Criteria: * documented chronic lymphocytic leukemia (CLL) requiring treatment according to International Working Group on CLL (iwCLL) criteria * adequate hematologic function: platelets ≥ 25.000/µl, neutrophils ≥ 1.000/µl and hemoglobin ≥8.0 g/dL, unless directly attributable to the patie...