Hypotheses: The Investigator hypothesizes that targeting ALL cells with 2 different
modalities, ie liposomal vincristine sulfate as a microtubule inhibitor and blinatumomab as a
BITE immuno-oncology therapy, will have at least additive benefits and allow an effective,
safe therapeutic option for patients. Further, the Investigator hypothesizes that the
combination will result in a high rate of response and thus allow enhanced immunologic
recovery.
Primary Objectives To evaluate whether the combination will result in a median
progression-free survival (PFS) of at least 1 year.
To evaluate if the complete remission/complete remission with incomplete hematological
recovery (CR/CRi*) rate is ≧ 75% following 2 cycles in adult subjects with R/R Ph- ALL and
duration of remission Secondary Objectives To evaluate the rate of Minimal Residual Disease
(MRD) and duration To evaluate the proportion of patients who are able to progress to
allogeneic transplantation To evaluate the safety of blinatumomab and liposomal vincristine
sulfate in combination To evaluate the effect of the combination and response on measures of
immune reconstitution