Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT199 · 1 trial · 1 indication
Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).
| Arm | Type | Description |
|---|---|---|
| ABT199 | EXPERIMENTAL | ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles |
| Name | Type | Description |
|---|---|---|
| ABT199 | DRUG | Oral BCL-2 antagonist |
Inclusion Criteria: * Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia (Owen 2003; Kyle 2003). * Measurable disease, defined as presence of ser...
ABT-199 is an investigational small molecule being studied for use in several blood cancers and autoimmune conditions, including chronic lymphocytic leukemia, non-Hodgkin lymphoma, small lymphocytic lymphoma, mantle-cell lymphoma, acute myelogenous leukemia, and lupus erythematosus. It is being developed by AbbVie Inc. and is currently in Phase 2 clinical development.
ABT-199 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational small molecule in Phase 2 clinical development for oncology and autoimmune indications.
ABT-199 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for multiple conditions, including chronic lymphocytic leukemia, non-Hodgkin lymphoma, and lupus erythematosus.
ABT-199 has completed three Phase 1 clinical trials. NCT01328626 evaluated safety and pharmacokinetics in 222 patients with relapsed or refractory chronic lymphocytic leukemia and non-Hodgkin lymphoma. NCT01682616 studied ABT-199 in combination with rituximab in 49 patients with relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma. NCT01686555 evaluated the drug in 97 female patients with systemic lupus erythematosus.
Yes, ABT-199 is being studied in mantle-cell lymphoma. A completed Phase 1 trial, NCT02419560, evaluated optimal dosing of ABT-199 in combination with ibrutinib in 37 patients with recurrent mantle-cell lymphoma. The trial was conducted in the United States.
ABT-199 has been studied in lupus erythematosus. A completed Phase 1 trial, NCT01686555, evaluated the safety, tolerability, and pharmacokinetics of ABT-199 in 97 female patients with systemic lupus erythematosus. The trial was conducted in the United States, Germany, Mexico, and Puerto Rico.