Therapy Detail

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Therapy Name Idelalisib + Rituximab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Idelalisib Zydelig CAL-101|GS-1101 PIK3CD inhibitor 27 Zydelig (idelalisib) inhibits PI3K-delta, preventing the activation of the PI3K signaling pathway and inhibiting tumor cell proliferation, motility, and survival (PMID: 24450857). Zydelig (idelalisib) is FDA approved for follicular B-cell non-Hodgkin lymphoma, relapsed small lymphocytic lymphoma, and in combination with Rituxan (rituximab) for relapsed chronic lymphocytic leukemia (FDA.gov).
Rituximab Rituxan IDEC-C2B8|MabThera CD20 Antibody 21 Rituxan (rituximab) is a chimeric mononclonal antibody that binds to CD20 on B-cells, resulting in induction of complement-dependent and antibody-dependent cytotoxicity, and potentially leading to decreased B-cell tumor growth (PMID: 28983798). Rituxan (rituximab) is FDA approved for use as monotherapy or in combination with chemotherapy in CD20-positive B-cell non-Hodgkin lymphoma, in combination with fludarabine and cyclophosphamide in CD20-positive chronic lymphocytic leukemia, and in combination with chemotherapy in pediatric patients (6 month to 18 years of age) with treatment-naive, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia (B-AL) (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
TP53 mutant chronic lymphocytic leukemia/small lymphocytic lymphoma sensitive Idelalisib + Rituximab Guideline Actionable Zydelig (idelalisib) combined with Rituxan (rituximab) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). detail...
TP53 loss chronic lymphocytic leukemia/small lymphocytic lymphoma sensitive Idelalisib + Rituximab Guideline Actionable Zydelig (idelalisib) combined with Rituxan (rituximab) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). detail...
TP53 mutant chronic lymphocytic leukemia sensitive Idelalisib + Rituximab Guideline Actionable Zydelig (idelalisib) and Rituxan (rituximab) combination therapy is included in the guidelines as first-line therapy for patients with advanced chronic lymphocytic leukemia harboring TP53 mutations and for patients with relapsed or refractory disease (PMID: 33091559; ESMO.org). detail... 33091559

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06205290 Phase III Idelalisib + Rituximab Lisocabtagene maraleucel Cyclophosphamide + Fludarabine Bendamustine + Rituximab A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies Withdrawn USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT 2
NCT04666038 Phase III Idelalisib + Rituximab Pirtobrutinib Bendamustine + Rituximab Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With CLL or SLL Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 14
NCT02044822 Phase II Idelalisib + Rituximab Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion Terminated USA | ITA | GBR | FRA | ESP | BEL | AUT | AUS 6


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