This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, cytarabine, mercaptopurine, methotrexate, and prednisone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving blinatumomab, inotuzumab ozogamicin, and combination chemotherapy may work better in treating patients with B acute lymphoblastic leukemia than chemotherapy alone.
Patients with newly diagnosed, previously untreated B-lineage ALL or lymphoblastic lymphoma, or having achieved complete remission (CR) with one course of induction chemotherapy; patients who require steroids, cytarabine (ara-c) or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible
Failure to one induction course of chemotherapy (these patients will be analyzed separately); patients who require steroids, ara-c or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible
Performance status of 0-3
Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)
Pregnant or nursing women
Known to be human immunodeficiency virus (HIV)-positive
Philadelphia chromosome (Ph)-positive ALL
Active and uncontrolled disease/infection as judged by the treating physician, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record
Single group
Blinatumomab
Biological/VaccineGiven IV
Cyclophosphamide
DrugGiven IV
Cytarabine
DrugGiven IT and IV
Dexamethasone
DrugGiven PO
Doxorubicin Hydrochloride
DrugGiven IV
Inotuzumab Ozogamicin
Biological/VaccineGiven IV
Laboratory Biomarker Analysis
Other interventionCorrelative studies
Mercaptopurine
DrugGiven PO
Methotrexate
DrugGiven IT, IV, and PO
Ofatumumab
Biological/VaccineGiven IV
Prednisone
DrugGiven PO
Rituximab
Biological/VaccineGiven IV
Vincristine Sulfate
DrugGiven IV
Relapse-free survival (RFS)
Will be estimated using the method of Kaplan and Meier. Will compute the Bayesian posterior probability. Will perform a competing risk analysis treating stem cell transplant as a competing event for RFS.
Overall survival
Will be estimated using the method of Kaplan and Meier.
Overall response rate
Will be estimated along with the exact 95% confidence intervals.
Minimal residual disease negativity rate
Will be estimated along with the exact 95% confidence intervals.
Incidence of adverse events
Will be summarized by organ type, grade and attribution to study treatment.
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
