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Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia
Sponsor: M.D. Anderson Cancer Center
Summary
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.
Official title: Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2016-11-01
Completion Date
2026-11-01
Last Updated
2025-11-06
Healthy Volunteers
No
Interventions
Blinatumomab
Given IV
Cyclophosphamide
Given IV
Cytarabine
Given IT and IV
Dexamethasone
Given PO
Doxorubicin Hydrochloride
Given IV
Inotuzumab Ozogamicin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Mercaptopurine
Given PO
Methotrexate
Given IT, IV, and PO
Ofatumumab
Given IV
Prednisone
Given PO
Rituximab
Given IV
Vincristine Sulfate
Given IV
Locations (1)
M D Anderson Cancer Center
Houston, Texas, United States