Status:
WITHDRAWN
Idelalisib With Rituximab, Ifosfamide, Carboplatin, Etoposide (RICE) in Children and Adolescents
Lead Sponsor:
Gilead Sciences
Conditions:
Diffuse Large B-Cell Lymphoma
Mediastinal B-cell Lymphoma
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03349346
Start Date
June 1 2019
End Date
February 1 2026
Last Update
December 11 2018
Active Locations (7)
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1
Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59000
2
Istituto Giannina Gaslini
Genova, Italy, 16147
3
Ospedale Pediatrico Bambino Gesu
Roma, Italy, 00165
4
Infantile Regina Margherita Hospital
Torino, Italy, 10126