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Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
Sponsor: M.D. Anderson Cancer Center
Summary
This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy 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 inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
Official title: Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
276
Start Date
2011-08-26
Completion Date
2027-12-25
Last Updated
2025-12-18
Healthy Volunteers
No
Conditions
Interventions
Blinatumomab
Given CIVI
Cyclophosphamide
Given IV
Cytarabine
Given IT and IV
Dexamethasone
Given IV or PO
Inotuzumab Ozogamicin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Mercaptopurine
Given PO
Methotrexate
Given IT, IV, and PO
Prednisone
Given PO
Rituximab
Given IV
Vincristine
Given IV
Locations (1)
M D Anderson Cancer Center
Houston, Texas, United States