ABOUT THIS STUDY
- Patients must have a confirmed diagnosis of CD22-positive, Philadelphia chromosome (Ph)-positive or Ph-negative B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. CD22 expression will be determined by multiparameter flow cytometry (MFC) or immunohistochemistry.
- Relapsed or refractory disease, as defined by any of the following:
- Unable to achieve complete response (CR) despite >= 4 weeks of initial course of systemic therapy.
- Recurrence of disease at any point after CR was achieved.
- (Note: patients with Ph-positive disease must have received >= 1 second- or third-generation ABL kinase inhibitor as part of their prior treatment to be eligible.)
- Detectable disease, as defined by any of the following:
- Presence of >= 5% abnormal blasts in the bone marrow or peripheral blood by morphology or MFC.
- Patients with isolated extramedullary disease will be permitted if there is >= 1 site of disease that measures >= 1.5 cm in longest diameter on cross-sectional imaging.
- Absolute neutrophil count (ANC) >= 1,000/uL.
- Hemoglobin >= 8 g/dL.
- Platelets >= 50,000/uL.
- Note: Transfusions and growth factor support will be permitted within 3 days of initiation of study treatment to reach these thresholds. As patients with relapsed/refractory ALL frequently have cytopenias due to marrow infiltration by the disease, no hematologic parameters will be required for enrollment if cytopenias can be attributed to disease.
- Total serum bilirubin =< 1.5 x upper limit of normal (ULN); (unless due to Gilbert syndrome or hemolysis; =< 2 x ULN for hepatic abnormalities considered disease-related).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN.
- Serum creatinine =< 1.5 x ULN or serum creatinine level associated with a measured or calculated creatinine clearance of >= 40 mL/min.
- Corrected QT (QTc) interval =< 500 msec; if assessed, left ventricular ejection fraction >= 40%.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Must agree to the use of effective contraception while on study treatment, unless they are highly unlikely to conceive (defined as  surgically sterilized, or  women who are and men whose sexual partner[s] is/are postmenopausal [i.e., a woman who is > 50 years old or who has not had menses for >= 1 year], or  not heterosexually active for the duration of the study).
- Patients with a circulating blast count of > 50,000/uL; systemic therapy with either
hydroxyurea, vincristine, and/or corticosteroids will be permitted within 3 days of
initiation of study treatment to reduce the blast count.
- Except for management of circulating blasts noted above, adequate duration from prior
therapy must be achieved before initiation of study treatment, as defined below:
- No cytotoxic or targeted systemic therapy < 2 weeks or 5 half-lives (whichever is
- No blinatumomab < 2 weeks.
- No radiation therapy < 4 weeks.
- No monoclonal antibody therapy < 6 weeks (except for prior InO, as discussed
- Patients previously treated with InO will be eligible, unless they meet ANY of the
- > 6 individual doses (e.g., > 2 standard cycles) were administered.
- Any documented hepatic toxicity observed was grade 3 or higher.
- The most recent dose was administered < 3 months from the initiation of study
- For patients that have received prior allogeneic HCT, they must be >= 4 months from
the date of stem cell infusion, with no prior history of sinusoidal obstruction
syndrome/veno-occlusive disease (SOS/VOD), and off all treatment for graft-vs-host
disease (GVHD) for >= 2 weeks. Patients with minimal active symptoms that can be
controlled with topical therapies and/or the equivalent of prednisone =< 10 mg/day
will be eligible.
- For patients that have received other forms of cellular immunotherapy (e.g., chimeric
antigen receptor-modified [CAR] T cells), they must be >= 21 days from cell infusion,
and any specific manifestations of cytokine release syndrome or neurologic toxicity
attributable to the cellular therapy have completely resolved (i.e., < grade 1)
- Patients with a known history of chronic liver disease, including but not limited to
cirrhosis, steatohepatitis, and chronic viral hepatitis. Patients with a history of
GVHD of the liver will be permitted, provided they meet all of the other eligibility
- Patients with isolated testicular or central nervous system disease.
- Known hypersensitivity or intolerance to any of the agents under investigation.
- May not be pregnant or nursing.
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