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 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
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/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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
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 Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 14


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