Idelalisib With Rituximab, Ifosfamide, Carboplatin, Etoposide (RICE) in Children and Adolescents
NCT ID: NCT03349346
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2019-06-30
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Idelalisib
Tablet (s) or dispersible tablets for suspension administered orally twice daily
Rituximab
375 mg/m\^2 administered intravenously
Ifosfamide
3 mg/m\^2 administered intravenously
Carboplatin
635 mg/m\^2 administered intravenously
Etoposide
100 mg/m\^2 administered intravenously
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.
Idelalisib
Tablet (s) or dispersible tablets for suspension administered orally twice daily
Rituximab
375 mg/m\^2 administered intravenously
Ifosfamide
3 mg/m\^2 administered intravenously
Carboplatin
635 mg/m\^2 administered intravenously
Etoposide
100 mg/m\^2 administered intravenously
Interventions
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Idelalisib
Tablet (s) or dispersible tablets for suspension administered orally twice daily
Rituximab
375 mg/m\^2 administered intravenously
Ifosfamide
3 mg/m\^2 administered intravenously
Carboplatin
635 mg/m\^2 administered intravenously
Etoposide
100 mg/m\^2 administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Relapsed or refractory disease
* Measurable or evaluable disease based on imaging or bone marrow examination
* Karnofsky ≥ 60% for participants \> 16 years of age or Lansky ≥ 60 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
* A negative serum pregnancy test is required for females of child bearing potential.
* Participants of child bearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception .
* Lactating females must agree to discontinue nursing before idelalisib is administered
* Adequate bone marrow function as defined in the protocol
* Adequate renal function as defined in the protocol
Exclusion Criteria
* Known active central nervous system or leptomeningeal lymphoma or within 4 weeks from the last intrathecal therapy prior to the required diagnostic lumbar puncture (LP) for this study
* Disease progression within 6 months from last anti-CD20 therapy
* Ongoing toxicity from prior cytotoxic therapy (last dose at least 3 weeks prior to study entry)
* Less than 4 half-lives from the last dose of previous targeted therapy and ongoing acute toxicity of prior targeted therapy
* Active infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), hepatitis B virus (HBV), or hepatitis C virus (HCV) based on screening serology and polymerase chain reaction (PCR) results
* Evidence of systemic bacterial, fungal, or viral infection at the time of treatment start (Day 1)
* Ongoing or history of drug-induced pneumonitis
* Ongoing or history of inflammatory bowel disease
* Pregnancy or breastfeeding
* Currently receiving other anti-cancer or other investigational drug
* Prior solid organ transplantation
* Prior allogeneic stem cell transplantation within 60 days or active acute graft versus host disease (GVHD) Grade 3 or higher
* Known hypersensitivity to idelalisib, the metabolites, or formulation excipients
* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the study requirements
1 Year
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Centre Hospitalier Régional Universitaire de Lille
Lille, , France
Istituto Giannina Gaslini
Genova, , Italy
Ospedale Pediatrico Bambino Gesu
Roma, , Italy
Infantile Regina Margherita Hospital
Torino, , Italy
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , Poland
Hospital Vall d´Hebrón
Barcelona, , Spain
Hospital Universitario HM Monteprincipe
Madrid, , Spain
Countries
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Other Identifiers
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2017-001468-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-313-1090
Identifier Type: -
Identifier Source: org_study_id