Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Venetoclax · 1 trial · 1 indication
Percentage of Participants With Best Overall Response (OR)(Defined as Complete Response \[CR\], Initial CR \[CRi\], Nodular Partial Response \[nPR\], PR) as Assessed by Investigator Determined Using iwCLL Guidelines
| Arm | Type | Description |
|---|---|---|
| Venetoclax + Rituximab | EXPERIMENTAL | Participants will be initially placed in a venetoclax 5 weeks ramp-up period, and will be administered an initial 20 mg oral tablet dose once daily (QD), incrementing weekly up to a maximum dose of 400 mg. Participants will then continue taking venetoclax 400 mg QD from Week 5 onwards, as directed by the investigator in combination with rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1 followed by 13.4 mL of rituximab SC 1,600 mg/26,800 Units vial (1,600 mg rituximab and 26,800 Units hyaluronidase human) on Day 1 of Cycle 2-6. |
| Name | Type | Description |
|---|---|---|
| Venetoclax | DRUG | Venetoclax will be administered as described in the reporting arm. |
| Rituximab | DRUG | Rituximab (IV) will be administered as described in the reporting arm. |
| Rituximab/Hyaluronidase Human | DRUG | Rituximab/Hyaluronidase Human (SC) ill be administered as described in the reporting arm. |
Inclusion Criteria: * Signed Informed Consent Form * Ability and willingness to comply with the requirements of the study protocol * Patient must have diagnosis of CLL that meets published 2008 IWCLL NCI-WG criteria. * Patient must have relapsed/refractory disease with an indication for treatment. ...
Venetoclax is being studied for the treatment of Chronic Lymphocytic Leukemia (CLL). It is an investigational small molecule in Phase 2 clinical development for this indication. The drug is being evaluated in patients with relapsed or refractory CLL, meaning the disease has returned or has not responded to prior treatment.
Venetoclax targets the B-cell lymphoma 2 (BCL-2) protein, which plays a role in cancer cell survival. By inhibiting BCL-2, the drug is designed to promote apoptosis, or programmed cell death, in cancer cells. This mechanism is being studied in the context of Chronic Lymphocytic Leukemia.
Venetoclax is being developed by Meridian Bioscience Inc, a company traded on the stock exchange under the ticker VIVO. The company is conducting clinical research on this drug for the treatment of Chronic Lymphocytic Leukemia.
Venetoclax is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is studying the drug in patients with relapsed or refractory Chronic Lymphocytic Leukemia.
Venetoclax is being studied in a Phase 2 clinical trial with the identifier NCT03467867. The trial is titled 'A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL' and is active but not recruiting participants. The study is enrolling 25 patients with Chronic Lymphocytic Leukemia in the United States.
Venetoclax is also known by the brand name Venclexta. In clinical trials, it is sometimes referred to by its investigational name ABT-199. These names refer to the same drug, which is being studied for the treatment of Chronic Lymphocytic Leukemia.