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 |
|---|---|---|---|---|---|---|
| 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 |
| NCT03370185 | Phase II | Duvelisib | Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma | Withdrawn | 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 |
| 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 |
| NCT03961672 | Phase II | Duvelisib | Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | 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) | Completed | USA | NZL | ITA | GBR | FRA | ESP | DEU | BEL | AUT | 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 |
| 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 |
| NCT04331119 | Phase II | Duvelisib | Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas | Recruiting | USA | 0 |
| NCT05044039 | Phase I | Duvelisib | Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy | Recruiting | USA | 0 |
| 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 |
| 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 |
| 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 |
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