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Therapy Name | Bendamustine + Idelalisib + Rituximab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Bendamustine | Treanda | Ribomustin|SyB L-0501|SDX-105 | Chemotherapy - Alkylating 14 | Treanda (bendamustine) is an alkylating agent with unique mechanisms, resulting in increased DNA damage and base-excision DNA repair pathway induction, and potentially leading to decreased growth of tumors, including those resistant to other alkylating agents (PMID: 18172283, PMID: 19117340, PMID: 19224851). Treanda (bendamustine) is FDA approved for use in chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma (FDA.gov). |
Idelalisib | Zydelig | CAL-101|GS-1101 | PIK3CD inhibitor 24 | 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 11 | 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, and in combination with fludarabine and cyclophosphamide in CD20-positive chronic lymphocytic leukemia (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
Unknown unknown | chronic lymphocytic leukemia | not applicable | Bendamustine + Idelalisib + Rituximab | Phase III | Actionable | In a Phase III trial, addition of Zydelig (idelalisib) to Bendamustine and Rituximab resulted in improved median progression-free survival (20.8 vs 11.1 months, HR=0.33, p<0.0001) compared to placebo in patients with relapsed or refractory chronic lymphocytic leukemia, although treatment associated adverse events were also increased (PMID: 28139405). | 28139405 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT01980888 | Phase III | Bendamustine + Idelalisib + Rituximab | Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia | Terminated | USA | CAN | 11 |
NCT02970318 | Phase III | Bendamustine + Idelalisib + Rituximab Acalabrutinib | A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL | Active, not recruiting | USA | CAN | 23 |