Inotuzumab Ozogamicin and Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of vincristine sulfate liposome (liposomal vincristine) and inotuzumab ozogamicin combination therapy in adult patients with relapsed and/or refractory B lineage acute lymphoblastic leukemia (B-ALL). II. To evaluate the overall response rate (ORR consisting of complete remission \[CR\], morphologic CR with incomplete blood count recovery \[CRi\], of combination therapy with liposomal vincristine and inotuzumab ozogamicin in adult patients with relapsed and/or refractory B lineage acute lymphoblastic leukemia. SECONDARY OBJECTIVES: I. To evaluate the leukemia-free survival (LFS) and overall survival (OS) of patients treated with this combination. II. To evaluate the number of patients able to proceed onto subsequent hematopoietic stem cell transplantation (HSCT) following combination therapy following combination therapy. III. To evaluate the overall incidence of unique toxicities associated with these agents, specifically peripheral neuropathy following vincristine sulfate liposome and veno-occlusive disease of the liver (VOD) following inotuzumab ozogamicin therapy. EXPLORATORY OBJECTIVES: I. To explore minimal residual disease (MRD) as a potential correlative biomarker of response to combination vincristine sulfate liposome and inotuzumab ozogamicin therapy. II. To explore potential biomarkers of response to vincristine sulfate liposome and inotuzumab ozogamicin therapy. III. To perform an analysis of the estimated cost of outpatient administration of vincristine sulfate liposome and inotuzumab ozogamicin. IV. To evaluate quality of life (QOL) of patients with relapsed/refractory B-ALL treated with vincristine sulfate liposome and inotuzumab ozogamicin. OUTLINE: This is a phase Ib, dose-escalation study of inotuzumab ozogamicin followed by a phase II study. INDUCTION/RE-INDUCTION: Patients receive vincristine sulfate liposome intravenously (IV) over 1 hour and inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve clinical benefit, defined as stable disease (SD), PR or CR, or CRi after 1-2 cycles, will continue on to maintenance therapy for up to 4-5 cycles. Patients who do not achieve clinical benefit after cycle 1 but do not experience dose-limiting toxicities (DLTs) receive a second cycle of vincristine sulfate liposome and inotuzumab ozogamicin. MAINTENANCE: Patients receive vincristine sulfate liposome IV over 1 hour on days 1 and 15 and inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 4-5 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 12 months.