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Obinutuzumab · 1 trial · 1 indication
The study is designed to demonstrate that 14 cycles of treatment with GAVe followed by up to 10 cycles maintenance with acalabrutinib for patients with detectable MRD at cycle 14 day 14 prolong PFS as compared to 12 cycles of treatment with GVe in patients with high risk CLL (defined as hav-ing at least one of the following risk factors: 17p-deletion, TP53- mutation or complex karyotype).
| Arm | Type | Description |
|---|---|---|
| GAVe-Arm | EXPERIMENTAL | Acalabrutinib plus Venetoclax plus Obinutuzumab plus (GAVe) |
| GVe-Arm | EXPERIMENTAL | Obinutuzumab plus Venetoclax (GVe) |
| Name | Type | Description |
|---|---|---|
| Obinutuzumab | DRUG | Obinutuzumab i.v. infusion: Cycle 1 Day 1: Obinutuzumab 100 mg i.v. Cycle 1 Day 1 (or 2): Obinutuzumab 900 mg i.v. Cycle 1 Day 8: Obinutuzumab 1000 mg i.v. Cycle 1 Day 15: Obinutuzumab 1000 mg i.v. Cycles 2-6: Day 1: Obinutuzumab 1000 mg i.v. |
| Venetoclax | DRUG | Venetoclax p.o.: Cycle 1: Days 22-28: Venetoclax 20 mg (2 x 10 mg) Cycle 2: Days 1-7: Venetoclax 50 mg (1 x 50 mg) Cycle 2:Days 8-14: Venetoclax 100 mg (1 x 100 mg) Cycle 2:Days: 15-21: Venetoclax 200 mg (2 x 100 mg) Cycle 2:Days: 22-28: Venetoclax 400 mg (4 x 100 mg) Cycles 3-12: Days 1-28: Venetoclax 400 mg (4 x 100 mg) |
| Acalabrutinib | DRUG | Cycles 15-24: Days 1-28: 100 mg acalabrutinib twice daily p.o. approx. every 12 hrs (corresponding to a total daily dose of 200 mg). |
Inclusion Criteria: * Documented CLL/SLL requiring treatment according to iwCLL criteria * Age at least 18 years * At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metapha...
Obinutuzumab is used for the treatment of Chronic Lymphocytic Leukemia (CLL). It is being studied in a Phase 3 clinical trial for previously untreated patients with high-risk CLL, where it is combined with other agents to assess its efficacy in this patient population.
Obinutuzumab is a monoclonal antibody, classified as a -mab (antibody) therapeutic. It is designed to target specific proteins on the surface of cancer cells, thereby helping the immune system to recognize and destroy these malignant cells in conditions like Chronic Lymphocytic Leukemia.
Obinutuzumab is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Chronic Lymphocytic Leukemia.
Obinutuzumab is currently in Phase 3 clinical development. It is being investigated as part of a combination therapy for previously untreated patients with high-risk Chronic Lymphocytic Leukemia, and the trial is actively recruiting participants.
Obinutuzumab is being studied in the clinical trial NCT05197192, a Phase 3 study that compares a combination of Acalabrutinib, Obinutuzumab, and Venetoclax against Obinutuzumab and Venetoclax alone in previously untreated patients with high-risk Chronic Lymphocytic Leukemia. The trial is recruiting in Germany.
Obinutuzumab is a distinct therapeutic agent developed by AstraZeneca. It is a monoclonal antibody used in the treatment of Chronic Lymphocytic Leukemia, and it is not known to be identical to any other drug in the context of its development and clinical investigation.