Comparing Inotuzumab Combined With Low Intensity Chemotherapy Plus Blinatumomab to Usual Chemotherapy Plus Blinatumomab in Older Adults With CD22+ B-cell Acute Lymphoblastic Leukemia
Summary
This phase II trial compares the combination of inotuzumab ozogamicin and low intensity chemotherapy and blinatumomab to the usual chemotherapy with blinatumomab in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. 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 CalichDMH to kill them. Chemotherapy drugs 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. A monoclonal antibody, such as blinatumomab, 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). Giving inotuzumab ozogamicin with chemotherapy and blinatumomab may help shrink the cancer and stop it from returning.
Timeline
- Start
- 2023-06-09
- Primary completion
- 2027-04-01
- Completion
- 2029-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Doxorubicin | Other / unclassified | — | Intravenous |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Intravenous |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Background | Methotrexate | Small molecule | — | Intravenous |
| Background | Methylprednisolone | Other / unclassified | — | Intravenous |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Vincristine | Small molecule | — | Intravenous |