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 + 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...
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 GA101 induction and maintenance therapy. The drug is currently in Phase 2 clinical development.
GA101 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate the safety and efficacy of GA101 in patients with Chronic Lymphocytic Leucemia.
GA101 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 2 trial for GA101 has been completed, with results expected to inform further development.
GA101 has been studied in one completed Phase 2 clinical trial registered as NCT02445131. The trial, titled "Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG)," enrolled 48 patients with Chronic Lymphocytic Leucemia in Germany. The study was uncontrolled and not randomized or double-blinded.
GA101 and CAL-101 are distinct drugs being studied in combination. The clinical trial NCT02445131 evaluates a sequential regimen that includes both CAL-101 and GA101 for the treatment of Chronic Lymphocytic Leucemia. GA101 is a separate investigational agent from CAL-101.