Idelalisib With Rituximab, Ifosfamide, Carboplatin, Etoposide (RICE) in Children and Adolescents

Korábbi kezelés

• 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
• 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
• 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
• 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.

Más betegség

• Disease progression within 6 months from last anti-CD20 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
• Known hypersensitivity to idelalisib, the metabolites, or formulation excipients

Egyéb

• Pregnancy or breastfeeding

• 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