Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Blinatumomab · 1 trial · 2 indications
Defined as the number of participants who achieve CR according to National Comprehensive Cancer Network (NCCN) Guidelines for Acute Lymphoblastic Leukemia (ALL), Version 2.2015
| Arm | Type | Description |
|---|---|---|
| Treatment (ibrutinib, blinatumomab) | EXPERIMENTAL | INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Blinatumomab | BIOLOGICAL | Given IV |
| Ibrutinib | DRUG | Given PO |
Inclusion Criteria: * Pathologically confirmed diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia/lymphoma with measurable bone marrow lymphoblasts or biopsy-proven extramedullary site measurable by computed tomography (CT) or positron emission tomography (PET)/CT imaging; Phil...
Blinatumomab is an investigational monoclonal antibody being studied for the treatment of Adult B Acute Lymphoblastic Leukemia, specifically in patients with relapsed or refractory disease that is Philadelphia Chromosome Positive. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Blinatumomab targets CD19, CD3E, CD3G, and CD3D. It is a cross-linking agent that works by bringing T cells and B cells together, which helps the immune system attack cancer cells. This mechanism is being evaluated in clinical trials for B Acute Lymphoblastic Leukemia.
Blinatumomab 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 Adult B Acute Lymphoblastic Leukemia.
Blinatumomab is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA for any use. The drug is being studied in a completed Phase 2 trial for Adult B Acute Lymphoblastic Leukemia, and its safety and efficacy have not yet been fully established.
Blinatumomab has been studied in one clinical trial, NCT02997761, titled 'Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia.' This Phase 2 trial was completed in the United States and enrolled 19 adult patients with Philadelphia Chromosome Positive disease.
Blinatumomab is a distinct investigational monoclonal antibody. It is not known to be the same as any other approved drug. Its unique mechanism of cross-linking CD19 and CD3 proteins sets it apart from other therapies being studied for B Acute Lymphoblastic Leukemia.