Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
1–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
