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 25 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 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
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
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
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 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

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03370185 Phase II Duvelisib Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma Suspended
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 Enrolling by invitation
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
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
NCT03961672 Phase II Duvelisib Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Recruiting
NCT04331119 Phase II Duvelisib Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas Recruiting
NCT04038359 Phase II Duvelisib A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma. (TEMPO) Recruiting
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
NCT01882803 Phase II Duvelisib A Phase 2 Study of IPI-145 in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO) Active, not recruiting
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
NCT01871675 Phase I Rituximab Duvelisib Bendamustine Phase Ib Study of IPI-145 in Combination With Bendamustine, Rituximab or Bendamustine/Rituximab in Hematologic Malignancies Completed
NCT03372057 Phase II Duvelisib A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL) Recruiting


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