Brief Summary
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug, called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.
Protocol Interventions
Procedure: Biospecimen Collection, Biological: Blinatumomab, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Biological: Inotuzumab Ozogamicin, Procedure: Lumbar Puncture, Drug: Ponatinib
Brief Summary
This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as [intervention], 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 with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.
Protocol Interventions
Drug: Allopurinol, Drug: Cytarabine, Drug: Daunorubicin Hydrochloride, Drug: Vincristine Sulfate, Drug: Dexamethasone, Drug: Pegylated L-Asparaginase, Drug: Methotrexate, Procedure: Bone Marrow Aspiration and Biopsy, Drug: Cyclophosphamide, Drug: Mercaptopurine, Biological: Rituximab, Drug: Doxorubicin, Drug: Thioguanine, Biological: Inotuzumab Ozogamicin, Other: Laboratory Biomarker Analysis
Brief Summary
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
Protocol Interventions
Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
