NCT03349346

Idelalisib With Rituximab, Ifosfamide, Carboplatin, Etoposide (RICE) in Children and Adolescents

Phase 1b Trial Evaluating Idelalisib in Children and Adolescents With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Mediastinal B-cell Lymphoma in Combination With RICE

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Diffuse Large B-Cell Lymphoma
• Mediastinal B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Idelalisib	Tablet (s) or dispersible tablets for suspension administered orally twice daily
DRUG	Rituximab	375 mg/m\^2 administered intravenously
DRUG	Ifosfamide	3 mg/m\^2 administered intravenously
DRUG	Carboplatin	635 mg/m\^2 administered intravenously
DRUG	Etoposide	100 mg/m\^2 administered intravenously

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-02-01
• Completion: 2026-02-01
• First posted: 2017-11-21
• Last updated: 2018-12-11

Locations

7 sites across 4 countries: France, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study