drugset / Trial / NCT05645718
Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
To learn if cyclophosphamide, vincristine, and dexamethasone (called mini hyper-CVD) in combination with intrathecal (delivered into the spine) chemotherapy (methotrexate, hydrocortisone, cytarabine) and compressed rituximab, blinatumomab, and inotuzumab ozogamicin (called cRIB) can help to control the disease.
Timeline
- Start
- 2023-07-14
- Primary completion
- 2027-12-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Blinatumomab | Monoclonal antibody | — | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Dexamethasone | Small molecule | — | Intravenous |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | — | Intravenous |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Intravenous |
| Subject | Methotrexate | Small molecule | — | Intravenous |
| Subject | Prednisone | Other / unclassified | — | Oral |
| Subject | Rituximab | Monoclonal antibody | — | Intravenous |
| Subject | Vincristine | Small molecule | — | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | Intravenous |