Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GA101 · 1 trial · 1 indication
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...
GA101 is an investigational small molecule being studied for the treatment of Chronic Lymphocytic Leucemia (CLL). It is being evaluated as part of a sequential regimen that includes bendamustine debulking followed by ABT-199 and GA101 induction and maintenance therapy. The drug is currently in Phase 2 clinical development.
GA101 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Chronic Lymphocytic Leucemia.
GA101 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a completed Phase 2 trial for the treatment of Chronic Lymphocytic Leucemia, with results expected to inform further development.
GA101 has been studied in one clinical trial with the identifier NCT02401503. This Phase 2 trial, titled 'Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG)', was conducted in Germany and enrolled 66 patients with Chronic Lymphocytic Leucemia. The trial has been completed.
No, GA101 is not the same as ABT-199. In the clinical trial NCT02401503, GA101 and ABT-199 are used as separate components of a sequential treatment regimen. GA101 is the investigational drug being developed by AbbVie, while ABT-199 is a different agent used in combination within the study protocol.