drugset / Trial / NCT05748171
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
RandomizedParallel-groupOpen-labelTreatment
Summary
This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and \<18 years) with High Risk (HR) or very high risk (VHR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.
Timeline
- Start
- 2023-05-17
- Primary completion
- 2033-05-21
- Completion
- 2036-05-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 20 mg/m2 | Oral |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 0.5 mg/m2 | — |
| Comparator | Mitoxantrone | Small molecule | 10 mg/m2 | — |
| Comparator | Pegaspargase | Protein / enzyme biologic | 1000 unknown | Intravenous |
| Comparator | Vincristine | Small molecule | 1.5 mg/m2 | — |
| Comparator | Asparaginase Erwinia chrysanthemi | Protein / enzyme biologic | 20000 unknown | Intravenous |