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 24 | 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 guidelines as first-line therapy for patients with advanced chronic lymphocytic leukemia harboring TP53 mutations and for patients with relapsed or refractory disease (PMID: 38969011; ESMO.org). | detail... 38969011 |
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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 | ROU | POL | ITA | HUN | GBR | FRA | ESP | DNK | CZE | BEL | AUT | AUS | 1 |
| 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 | TUR | POL | ITA | ISR | IRL | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 6 |
| 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 | SWE | NOR | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT | 0 |
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