14 completed, 8 terminated, 3 withdrawn, 1 active not recruiting. 12 Phase 1, 12 Phase 2, 5 Phase 3.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides Duvelisib - Mycosis Fungoides, Cutaneous T-cell Lymphoma | Phase 1 | Not yet recruiting | SecuraBio | 30 | 2027-01-01 | 2026-07-20 |
| A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype Duvelisib, Gemcitabine, Bendamustine - Lymphoma | Phase 3 | Recruiting | SecuraBio | 124 | 2025-05-19 | 2026-04-06 |
| Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy Duvelisib, CAR T-cells - Non-Hodgkin Lymphoma, Acute Lymphocytic Leukemia | Phase 1 | Active not recruiting | Washington University School of Medicine | 42 | 2022-02-28 | 2026-09-24 |
| Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas Duvelisib, Peripheral blood draw - T-Cell Lymphoma | Phase 2 | Terminated | Washington University School of Medicine | 17 | 2020-07-23 | 2026-05-06 |
| A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer Duvelisib, Pembrolizumab - Head and Neck Squamous Cell Carcinoma | Phase 1 / Phase 2 | Terminated | SecuraBio | 2 | 2020-06-01 | 2023-09-21 |
| Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL duvelisib, PI3K inhibitor - Lymphoma, Small Lymphocytic, Lymphoma | Terminated | SecuraBio | 2 | 2020-04-23 | 2021-03-17 | |
| A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma Duvelisib - Indolent Non-Hodgkin Lymphoma | Phase 2 | Completed | SecuraBio | 103 | 2019-09-24 | 2024-09-19 |
| A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) Duvelisib - Peripheral T-cell Lymphoma | Phase 2 | Completed | SecuraBio | 156 | 2018-02-22 | 2025-03-07 |
| Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma Duvelisib - Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma | Phase 2 | Withdrawn | SecuraBio | 2018-02-12 | 2023-02-28 | |
| Panobinostat, Carfilzomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma Carfilzomib, Chemosensitivity Assay, Dexamethasone - Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma | Phase 2 | Terminated | University of Washington | 9 | 2018-02-08 | 2022-05-09 |
| A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145) Duvelisib - Hematologic Malignancy | Phase 2 | Completed | SecuraBio | 19 | 2016-04-01 | 2023-09-11 |
| 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) Duvelisib, Placebo, Rituximab - Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma | Phase 3 | Withdrawn | SecuraBio | 2015-12-01 | 2021-03-17 | |
| Duvelisib With Rituximab vs R-CHOP in Subjects With Relapsed/Refractory Follicular Lymphoma (FRESCO) Duvelisib, Rituximab, R-CHOP - Lymphoma | Phase 2 | Withdrawn | SecuraBio | 2015-12-01 | 2021-03-17 | |
| Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY) IPI-145 (duvelisib), Obinutuzumab - Lymphocytic Leukemia, Chronic, Lymphoma, Small Lymphocytic | Phase 1 | Terminated | SecuraBio | 3 | 2015-02-01 | 2023-02-27 |
| A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO) Duvelisib, Rituximab, Obinutuzumab - CD20+ Follicular Lymphoma | Phase 1 / Phase 2 | Terminated | SecuraBio | 55 | 2014-12-01 | 2023-09-28 |
| Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145 IPI-145 (duvelisib), IPI-145 - Healthy | Phase 1 | Completed | SecuraBio | 103 | 2014-11-01 | 2021-03-17 |
| Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma Duvelisib, Placebo, Rituximab - Follicular Lymphoma | Phase 3 | Terminated | SecuraBio | 13 | 2014-09-01 | 2023-09-28 |
| Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects IPI-145 - Hepatic Impairment | Phase 1 | Completed | SecuraBio | 24 | 2014-03-01 | 2021-03-17 |
| A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07 IPI-145, Ofatumumab - Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma | Phase 3 | Completed | SecuraBio | 99 | 2013-12-01 | 2023-09-21 |
| A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) Duvelisib, Ofatumumab - Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma | Phase 3 | Completed | SecuraBio | 319 | 2013-11-01 | 2023-09-21 |
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Leukemia, Lymphocytic, Chronic, B-Cell (6) · Lymphoma (5) · Lymphoma, Follicular (4) · Recurrence (3) · Hematologic Neoplasms (2) · Hereditary Sensory and Autonomic Neuropathies (2) · Lymphoma, Non-Hodgkin (2) · Lymphoma, T-Cell (2) · Lymphoma, T-Cell, Peripheral (2) · Arthritis, Rheumatoid (1) · Asthma (1) · Head and Neck Neoplasms (1) · Immunoblastic Lymphadenopathy (1) · Leukemia (1) · Lymphoma, B-Cell, Marginal Zone (1)
duvelisib (27) · Rituximab (4) · Bendamustine Hydrochloride (2) · obinutuzumab (2) · ofatumumab (2) · Calcium Dobesilate (1) · Dexamethasone (1) · Gemcitabine (1) · Immune Checkpoint Inhibitors (1) · Immunotherapy, Adoptive (1) · Midazolam (1) · Panobinostat (1) · Prednisone (1) · R-CHOP protocol (1) · Rifampin (1)
United States (22) · Italy (9) · United Kingdom (8) · Germany (7) · France (6) · Belgium (5) · Spain (5) · Hungary (4) · Poland (4) · Australia (3) · Czechia (3) · Netherlands (3) · New Zealand (3) · Austria (2) · Bulgaria (2)
Hagop Youssoufian, MD (14) · Amanda Cashen, M.D. (1) · Andrew Cowan (1) · Armin Ghobadi, M.D. (1) · Reuven Chantre, MD (1)
PMID 28017967, PMID 29191916, PMID 29233821, PMID 30287523, PMID 30742566, PMID 42018969
2019 (2), 2014 (1), 2015 (1), P30CA015704 (1)