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 27 PIK3CG inhibitor 10 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
TP53 mutant chronic lymphocytic leukemia/small lymphocytic lymphoma 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...
TP53 loss chronic lymphocytic leukemia/small lymphocytic lymphoma 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...
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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02004522 Phase III Duvelisib Ofatumumab A Phase 3 Study of IPI-145 Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) Completed USA | NZL | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS 1
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) Completed USA | ITA | GBR | FRA | ESP | CAN | BEL 5
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 ITA | FRA | AUS 1
NCT04890236 Phase I Tisagenlecleucel Duvelisib Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study Recruiting USA 0
NCT04038359 Phase II Duvelisib A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma. (TEMPO) Completed USA | ITA | GBR | DEU 4
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
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
NCT03370185 Phase II Duvelisib Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma Withdrawn USA 0
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 | NZL | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS 1
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
NCT03372057 Phase II Duvelisib A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL) Completed USA | ITA | GBR | DEU 0
NCT05044039 Phase I Duvelisib Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy Recruiting USA 0
NCT03961672 Phase II Duvelisib Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Active, not recruiting USA 0


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