Condition: B Acute Lymphoblastic Leukemia · B Lymphoblastic Lymphoma · Central Nervous System Leukemia · Sponsor: Children's Oncology Group
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol 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. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with …
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| Children's Hospital of Alabama | Birmingham, Alabama, United States | Recruiting |
| USA Health Strada Patient Care Center | Mobile, Alabama, United States | Recruiting |
| Providence Alaska Medical Center | Anchorage, Alaska, United States | Recruiting |
| Banner Children's at Desert | Mesa, Arizona, United States | Recruiting |
| Phoenix Childrens Hospital | Phoenix, Arizona, United States | Recruiting |
| Banner University Medical Center - Tucson | Tucson, Arizona, United States | Recruiting |
| Arkansas Children's Hospital | Little Rock, Arkansas, United States | Recruiting |
| Kaiser Permanente Downey Medical Center | Downey, California, United States | Recruiting |
| City of Hope Comprehensive Cancer Center | Duarte, California, United States | Recruiting |
| Loma Linda University Medical Center | Loma Linda, California, United States | Recruiting |
| Miller Children's and Women's Hospital Long Beach | Long Beach, California, United States | Recruiting |
| Children's Hospital Los Angeles | Los Angeles, California, United States | Recruiting |
+ 219 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03959085