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

NCT03349346 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-12-11

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2021-02-28
Completion
2026-02-28
FDA Drug
Yes

Countries

  • France
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03349346 on ClinicalTrials.gov