Therapy Detail

Therapy Name Idelalisib
Therapy Description

Zydelig (idelalisib) inhibits PI3K-delta, preventing the activation of the PI3K signaling pathway and inhibiting tumor cell proliferation, motility, and survival (NCI Drug Dictionary). Zydelig (idelalisib) is FDA approved for follicular B-cell non-Hodgkin lymphoma, relapsed small lymphocytic lymphoma, and chronic lymphocytic leukemia (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
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 (NCI Drug Dictionary). Zydelig (idelalisib) is FDA approved for follicular B-cell non-Hodgkin lymphoma, relapsed small lymphocytic lymphoma, and chronic lymphocytic leukemia (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown hematologic cancer not applicable Idelalisib Phase I Actionable In a Phase I trial, Zydelig (idelalisib) treatment of patients with hematological malignancies produced an overall response rate of 72% (39/54) (PMID: 24615777). 24615777
Unknown unknown chronic lymphocytic leukemia not applicable Idelalisib Preclinical - Cell culture Actionable In a preclinical study, Zydelig (idelalisib) inhibited proliferation, however, also resulted in increased activation-induced cytidine deaminase (AID) expression and genomic instability in a chronic lymphocytic leukemia cell line in culture (PMID: 28199309). 28199309
Unknown unknown Hodgkin's lymphoma not applicable Idelalisib Phase II Actionable In a Phase II trial, Idelalisib treatment resulted in an overall response rate of 20% (5/25) in Hodgkin's lymphoma patients, with one patient experiencing a complete response and four patients experiencing a partial response (PMID: 28327905). 28327905
Clinical Trial Phase Therapies Title Recruitment Status
NCT03133221 Phase II Idelalisib 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation Recruiting
NCT01732926 Phase III Idelalisib Bendamustine + Rituximab Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Terminated
NCT03126019 Phase II INCB050465 Idelalisib An Open-Label, Randomized Study Comparing INCB050465 to Idelalisib in Relapsed or Refractory Follicular Lymphoma (CITADEL-203) Recruiting
NCT01732913 Phase III Idelalisib Rituximab Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Terminated
NCT01306643 Phase Ib/II Idelalisib Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma Completed
NCT02662296 Phase II Idelalisib Ibrutinib Ibrutinib or Idelalisib in Treating Patients With Persistent or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma After Donor Stem Cell Transplant Withdrawn