Clinical trial · Interventional
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
NCT03349346CI-TRIAL-00036078withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The European Medical Agency granted a Paediatric Investigational Product-specific waiver on the grounds that idelalisib is likely to be unsafe in paediatrics
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Mediastinal B-cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Idelalisib | Drug | Idelalisib | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1- Participants 12 to less than 18 years of age
- description
- 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.
- interventionNames
- Drug: Idelalisib
- Drug: Rituximab
- Drug: Ifosfamide
- Drug: Carboplatin
- Drug: Etoposide
- type
- EXPERIMENTAL
- label
- Cohort 2- Participants 1 to less than 12 years of age
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically confirmed diagnosis of DLBCL or MBCL established by the World Health Organization (WHO) 2008 classification of tumors of hematopoietic and lymphoid tissues * 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 Key Exclusion Criteria: * Prior ifosfamide, carboplatin, etoposide (ICE) therapy, with or without an anti-CD20 antibody, or history of hypersensitivity to any components of RICE * 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 NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.