A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

Conditions

• Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex

ALL

Age

1 Year - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  Participants will receive Ibrutinib (dose 240 mg/m\^2 /329 mg/m\^2 per day) during part 1 and part 2.
• Rituximab — DRUG
  Participants will receive a cumulative dose of rituximab 750 mg/m\^2 as a part of RICE/RVICI regimen in part 1 and part 2 per cycle.
• Ifosfamide — DRUG
  Participants will receive a cumulative dose of Ifosfamide 9 g/m\^2 and 10 g/m\^2 as a part of RICE and RVICI regimen respectively in part 1 and part 2 per cycle.
• Carboplatin — DRUG
  Participants will receive a cumulative dose of carboplatin 635 mg/m\^2 and 800 mg/m\^2 as a part of RICE and RVICI regimen respectively in part 1 and part 2 per cycle.
• Etoposide — DRUG
  Participants will receive a cumulative dose of etoposide 300 mg/m\^2 in part 1 and part 2 as a part of RICE regimen per cycle.
• Vincristine — DRUG
  Participants will receive a cumulative dose of vincristine 1.6 mg/m\^2 in part 1 and part 2 as a part of RVICI regimen per cycle.
• Idarubicin — DRUG
  Participants will receive a cumulative dose of idarubicin 20 mg/m\^2 in part 1 and part 2 as a part of RVICI regimen per cycle.
• Dexamethasone — DRUG
  Participants will receive a cumulative dose of dexamethasone 100 mg/m\^2 in part 1 and part 2 as a part of RICE/RVICI regimen per cycle.

Study Details

The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival \[EFS\]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).

Key Dates

Start date

Jul 1, 2016

Status verified

Nov 2022

Primary completion

Jun 11, 2021

Completion

Jun 11, 2021

Study Design

Enrollment

72 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Ibrutinib
  The first 2 participants enrolled in each age group (1-5 years, 6-11 years and 12-17 years) will receive starting dose of Ibrutinib 240 milligram per square meter (mg/m\^2) for the first cycle, followed by dose escalation at the start of Cycle 2 as long as all pharmacokinetic assessments are within the expected range and there are no safety concerns. For participants being treated at 240 mg/m\^2 dose level during the first cycle, the maximum dose should not exceed a total of 420 mg/day. All participants will receive rituximab, ifosfamide, carboplatin, etoposide and dexamethasone (RICE) or ituximab, vincristine, ifosfamide, carboplatin, idarubicin and dexamethasone (RVICI) background therapy (investigator's choice), during treatment phase. Participants with PR or better only will receive Ibrutinib for 3 cycles or until PD, unacceptable toxicity or until initiating antilymphoma therapy or a conditioning regimen for stem cell transplantation during post-treatment phase.
• Experimental: Part 2: Ibrutinib
  Participants will either receive ibrutinib and RICE/RVICI background therapy or RICE/RVICI background therapy alone, until 3 cycles are completed or until PD or unacceptable toxicity during the treatment phase. Participants who received ibrutinib and RICE/RVICI background therapy and with PR or better only will receive ibrutinib alone for 3 cycles during post-treatment phase.

Primary Outcome Measure

Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib [ Time Frame: Up to Cycle 3 (each cycle of 21 or 28 days) ]

Locations (17)

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