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

Sponsor
Gilead Sciences
Study ID
NCT03349346
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Jun 30, 2019
Status verified
Dec 2018
Primary completion
Feb 28, 2021
Completion
Feb 28, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1- Participants 12 to less than 18 years of age
    Participants will receive idelalisib monotherapy (from day 1 to day 21), followed by combination therapy with RICE. Upon enrollment, participants will be assigned to one of the 3 dose levels during idelalisib monotherapy (Dose level 1 = 55 mg/m\^2 twice daily (BID), Dose level 2 = 85 mg/m\^2 BID, Dose level 3 = 125 mg/m\^2 BID) administered as 50 mg, 100 mg or 150 mg tablets as appropriate, or as 10 mg dispersible tablets for oral suspension for participants who cannot swallow tablets. * Day 1: single dose of idelalisib * Day 2 up to Day 21: initiate and continue idelalisib BID dosing * Day 22 for up to 12 months: idelalisib twice per day in combination with RICE. Cycles of RICE will be administered over 5 days every 3 weeks (Day 1: rituximab; Day 3: rituximab, ifosfamide, carboplatin, etoposide; Days 4 and 5: ifosfamide, etoposide) starting day 22 (or earlier if there is evidence of clinical progression while on idelalisib monotherapy) for up to 12 months.
  • Experimental: Cohort 2- Participants 1 to less than 12 years of age
    Participants will receive one of the 3 doses of idelalisib monotherapy (from day 1 to day 21) followed by combination therapy with RICE. Idelalisib will be administered as as 50 mg, 100 mg or 150 mg tablets as appropriate, or as 10 mg dispersible tablets for oral suspension for participants who cannot swallow tablets. Participants will will be enrolled at dose level 1 once tolerability is demonstrated in the older cohort (Cohort 1). Thereafter, both age cohorts will be dose escalated independently. * Day 1: single dose of idelalisib * Day 2 up to Day 21: initiate and continue idelalisib BID * Day 22 for up to 12 months: idelalisib twice per day in combination with RICE. Cycles of RICE will be administered over 5 days every 3 weeks (Day 1: rituximab; Day 3: rituximab, ifosfamide, carboplatin, etoposide; Days 4 and 5: ifosfamide, etoposide) starting day 22 (or earlier if there is evidence of clinical progression while on idelalisib monotherapy) for up to 12 months.

Primary Outcome Measure

Incidence Rate of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 21 ]

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