: The purpose of this study is to test whether blinatumomab in combination with TKI therapy (such as dasatinib) is an effective treatment for people with Ph+ ALL. Researchers want to improve the response to standard-of-care treatment of corticosteroids + TKI therapy by adding the study drug, blinatumomab.
Description: (MRD negativity by flow cytometry and quantitative PCR of BCR-ABL transcripts) at any time during TKI + corticosteroid induction or consolidation with up to 3 cycles of blinatumomab in combination with TKI.Measure: Proportion of evaluable patients achieving complete molecular response Time: 7 months
Description: assessed by NCI CTCAE v5.0 and rates of blinatumomab discontinuation due to toxicity among all patients beginning the consolidation portion of the study on dasatinib. The window for toxicity evaluation for this objective extends from the beginning of consolidation of the study until completion of maintenance or removal from study, whichever is sooner."Measure: Frequency, severity, and co-occurrence of treatment-related grade 3-4 toxicities Time: 13 months
Description: As assessed by sequencing of the ABL kinase gene in bone marrow or peripheral blood, observed in patients experiencing progression of B-ALL following consolidative therapy with blinatumomab in combination with an oral TKI.Measure: Frequency, type, and co-occurrence of ABL kinase mutations Time: 2 years
Description: As assessed by next-generation sequencing of bone marrow or peripheral blood, in patients experiencing progression of B-ALL following consolidative therapy with blinatumomab in combination with an oral TKI.Measure: Frequency, type, and co-occurrence of new somatic mutations Time: 2 years
Single Group Assignment
There is one SNP
- Presence of known ABL kinase mutations conferring resistance to dasatinib at time of study entry, including T315I mutation. --- T315I ---