Therapy Detail

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Therapy Name Idelalisib
Synonyms
Therapy Description

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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Idelalisib Zydelig CAL-101|GS-1101 PIK3CD inhibitor 25 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
TP53 mutant CLL/SLL sensitive Idelalisib Guideline Actionable Zydelig (idelalisib) 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 CLL/SLL sensitive Idelalisib Guideline Actionable Zydelig (idelalisib) 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...
PIK3CA Q1033R PIK3CA H1047R Burkitt lymphoma predicted - sensitive Idelalisib Case Reports/Case Series Actionable In a clinical case study, Zydelig (idelalisib) treatment resulted in tumor shrinkage and decreased plasma LDH that continued for 10 months before recurrence in a patient with relapsed Burkitt lymphoma harboring PIK3CA H1047R and PIK3CA Q1033R (PMID: 32193631). 32193631
BRAF V600E/K PIK3CA wild-type melanoma no benefit Idelalisib Preclinical Actionable In a preclinical study, Zydelig (idelalisib) did not inhibit proliferation of melanoma cell lines harboring BRAF V600E/K and wild-type PIK3CA in culture (PMID: 26137449). 26137449

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03133221 Phase II Idelalisib 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation Active, not recruiting USA 0
NCT03126019 Phase II Parsaclisib Idelalisib An Open-Label, Randomized Study Comparing INCB050465 to Idelalisib in Relapsed or Refractory Follicular Lymphoma (CITADEL-203) Active, not recruiting USA | CAN 11
NCT02536300 Phase III Idelalisib Dose Optimization Study of Idelalisib in Follicular Lymphoma Recruiting USA | CAN 9
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 USA 0
NCT03151057 Phase I Idelalisib Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies Active, not recruiting USA 0
NCT01732913 Phase III Idelalisib Rituximab Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Terminated USA 18
NCT04699461 Phase II Idelalisib Loncastuximab tesirine-lpyl Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or Refractory Follicular Lymphoma (LOTIS 6) Recruiting USA 0
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 USA | CAN 13
NCT01306643 Phase Ib/II Idelalisib Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma Completed USA 0
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Recruiting USA 0


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