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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
liposomal vincristine 2.25 mg/m2 weekly x 3 per cycle (weeks 3-5 in cycle 1 and 2-4 in subsequent cycles)
Moffitt Cancer Center
Tampa, Florida, United States
Duke University
Durham, North Carolina, United States
Novant Health Cancer Institute and Innovation Center
Winston-Salem, North Carolina, United States
Progression-free survival (PFS)
patient report
Time frame: At 1 year
Complete remission/complete remission with incomplete hematological recovery (CR/CRi*) rate
lab reports
Time frame: End of Cycle 2 (1 cycle is 6 weeks in duration)
Minimal Residual Disease (MRD) and duration
Flow Measurement
Time frame: End of Cycle 2 (1 cycle is 6 weeks in duration)
Minimal Residual Disease (MRD) and duration
Flow Measurement
Time frame: End of Therapy (up to 58 weeks)
Proportion of patients able to progress to allogeneic transplantation
Investigator reported
Time frame: End of study (up to 58 weeks)
Safety of blinatumomab and liposomal vincristine sulfate in combination, as measured by rate of toxicity
Investigator report of toxicities
Time frame: Through all cycles of therapy (up to 58 weeks)
Immune reconstitution, as measured by the immune reconstitution panel
immune reconstitution panel
Time frame: End of study (up to 58 weeks)
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