drugset / Trial / NCT05848687
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Phase 1/2
Recruiting
90 enrolled
Tanja Andrea Gruber
Amgen · collabCannonball Kid's Cancer · collabKura Oncology, Inc. · collabLucile Packard Foundation for Children's Health · collabThe Pediatric Oncology Experimental Therapeutics Investigators' Consortium · collabUnited States Department of Defense · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.
Timeline
- Start
- 2023-11-03
- Primary completion
- 2028-12
- Completion
- 2033-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Blinatumomab | Monoclonal antibody | 15 ug/m2 | — |
| Subject | Ziftomenib | Small molecule | — | — |
| Background | Bortezomib | Small molecule | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Background | Methotrexate | Small molecule | — | Intravenous |
| Background | Mitoxantrone | Small molecule | — | Intravenous |
| Background | Pegaspargase | Protein / enzyme biologic | — | Intravenous |
| Background | Vorinostat | Small molecule | — | Oral |