Therapy Detail

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Therapy Name Duvelisib
Synonyms
Therapy Description

Copiktra (duvelisib) prevents the activation of the PI3K delta/gamma-mediated signaling pathways, resulting in tumor cell death (PMID: 25258342). Copiktra (duvelisib) is FDA approved for use in adult patients with relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and follicular lymphoma (FDA.gov)

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Duvelisib Copiktra IPI-145|INK1197 PIK3CD inhibitor 24 PIK3CG inhibitor 8 Copiktra (duvelisib) prevents the activation of the PI3K delta/gamma-mediated signaling pathways, resulting in tumor cell death (PMID: 25258342). Copiktra (duvelisib) is FDA approved for use in adult patients with relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and follicular lymphoma (FDA.gov)

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown cutaneous T cell lymphoma not applicable Duvelisib Phase I Actionable In a Phase I trial, Copiktra (duvelisib) treatment resulted in an overall response rate of 31.6% (6/19, 6 partial response) with a median duration of treatment of 12.6 weeks in patients with cutaneous T cell lymphoma (PMID: 29233821; NCT01476657). 29233821
TP53 mutant CLL/SLL sensitive Duvelisib Guideline Actionable Copiktra (duvelisib) 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...
Unknown unknown chronic lymphocytic leukemia not applicable Duvelisib Phase I Actionable In a Phase I trial, Copiktra (duvelisib) demonstrated safety and efficacy in patients with advanced chronic lymphocytic leukemia (PMID: 24501284). 24501284
TP53 loss CLL/SLL sensitive Duvelisib Guideline Actionable Copiktra (duvelisib) 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...
Unknown unknown mantle cell lymphoma not applicable Duvelisib Preclinical - Cell culture Actionable In a preclinical study, Copiktra (duvelisib) inhibited proliferation, and resulted in an increase in activation-induced cytidine deaminase (AID) expression and genomic instability in a mantle cell lymphoma cell line in culture (PMID: 28199309). 28199309
TP53 mutant chronic lymphocytic leukemia predicted - sensitive Duvelisib Phase I Actionable In a Phase I trial, Copiktra (duvelisib) treatment inhibited Akt phosphorylation, resulted in complete response in 2% (1/49), partial response in 53% (26/49), and stable disease in 43% (21/49) of chronic lymphocytic leukemia patients, of which 49% (23/47) carried TP53 mutations (Blood 124 (21): 3334). detail...
Unknown unknown non-Hodgkin lymphoma not applicable Duvelisib Phase I Actionable In a Phase I trial, Copiktra (duvelisib) treatment resulted in complete response in 16% (5/31), partial response in 45% (14/31), minor response in 3% (1/31), and stable disease in 29% (9/31) in non-Hodgkin lymphoma patients (Blood 124(21): 802). detail...
Unknown unknown peripheral T-cell lymphoma not applicable Duvelisib Phase I Actionable In a Phase I trial, Copiktra (duvelisib) treatment resulted in an overall response rate of 50% (8/16, 3 complete response, 5 partial response) with a median duration of treatment of 11.3 weeks in patients with peripheral T-cell lymphoma (PMID: 29233821; NCT01476657). 29233821

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02049515 Phase III Ofatumumab Duvelisib A Phase 3 Extension Study of IPI-145 and Ofatumumab in Patients With CLL/SLL Previously Enrolled in Study IPI-145-07 Completed USA 10
NCT04038359 Phase II Duvelisib A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma. (TEMPO) Recruiting USA 7
NCT02158091 Phase Ib/II Cyclophosphamide + Fludarabine + Rituximab Duvelisib A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL Active, not recruiting USA 0
NCT02576275 Phase III Bendamustine + Rituximab Duvelisib A Study of Duvelisib in Combination With Rituximab and Bendamustine vs Placebo in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma (BRAVURA) Withdrawn USA 0
NCT02004522 Phase III Duvelisib Ofatumumab A Phase 3 Study of IPI-145 Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) Active, not recruiting USA 10
NCT01871675 Phase I Rituximab Duvelisib Bendamustine Phase Ib Study of IPI-145 in Combination With Bendamustine, Rituximab or Bendamustine/Rituximab in Hematologic Malignancies Completed USA 0
NCT03370185 Phase II Duvelisib Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma Withdrawn USA 0
NCT02204982 Phase III Duvelisib Rituximab Study of IPI-145 in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma (DYNAMO + R) Terminated 4
NCT04331119 Phase II Duvelisib Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas Recruiting USA 0
NCT01882803 Phase II Duvelisib A Phase 2 Study of IPI-145 in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO) Active, not recruiting USA | CAN 10
NCT03372057 Phase II Duvelisib A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL) Recruiting USA 3
NCT03961672 Phase II Duvelisib Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Recruiting USA 0


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