drugset / Trial / NCT03349346
Idelalisib With Rituximab, Ifosfamide, Carboplatin, Etoposide (RICE) in Children and Adolescents
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objectives of this study are to evaluate safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of idelalisib; and to establish recommended phase 2 doses (RP2D) of idelalisib in combination with rituximab, ifosfamide, carboplatin, etoposide (RICE) in children and adolescents with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mediastinal B-cell lymphoma (MBCL)
Timeline
- Start
- 2019-06
- Primary completion
- 2021-02
- Completion
- 2026-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Idelalisib | Small molecule | 55 mg/m2 | Oral |
| Subject | Idelalisib | Small molecule | 85 mg/m2 | Oral |
| Subject | Idelalisib | Small molecule | 125 mg/m2 | Oral |
| Background | Carboplatin | Small molecule | 635 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Background | Ifosfamide | Small molecule | 3 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |