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Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia
Sponsor: M.D. Anderson Cancer Center
Summary
This phase II trial studies how well combination chemotherapy and inotuzumab ozogamicin work in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute lymphoblastic leukemia.
Official title: Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4
Start Date
2018-03-28
Completion Date
2020-04-02
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
Cyclophosphamide
Given IV
Cytarabine
Given IT or IV
Dexamethasone
Given IV or PO
Doxorubicin Hydrochloride
Given IV
Inotuzumab Ozogamicin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Leucovorin Calcium
Given IV
Mercaptopurine
Given PO
Methotrexate
Given IT, IV or 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