Duvelisib

Generic Name: Duvelisib

Brand Names: Copiktra

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₁₇ClN_₆O

CAS Number: 1201438-56-3

Unique Ingredient Identifier: 610V23S0JI

Background: Duvelisib, also known as IPI-145 and INK-1197, is a small-molecule inhibitor of phosphoinositide-3 kinases that was designed initially to prove that simultaneous inhibition of the isoforms delta and gamma can produce a broad adaptative and innate immune cell inhibitory activity. All the work around duvelisib showed that this agent is a potent inhibitor of both forms. Duvelisib was developed by Verastem, Inc and FDA approved on September 24, 2018.

Indication: Duvelisib is indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have trialed at least two prior therapies.

Associated Conditions: Refractory Small Lymphocytic Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia (CLL), Relapsed Small Lymphocytic Lymphoma

Clinical Trials

Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Phase 1

Not yet recruiting

Conditions: T-cell-prolymphocytic Leukemia
Cutaneous T-Cell Lymphoma Refractory

Interventions: Drug: Duvelisib
Drug: Venetoclax

First Posted Date: 2025-02-06

Last Posted Date: 2025-04-15

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 12

Registration Number: NCT06810778

Locations: 🇺🇸
David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, California, United States

A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype

Phase 3

Recruiting

Conditions: Lymphoma

Interventions: Drug: Duvelisib
Drug: Gemcitabine
Drug: Bendamustine

First Posted Date: 2024-07-26

Last Posted Date: 2025-04-25

Lead Sponsor: SecuraBio

Target Recruit Count: 124

Registration Number: NCT06522737

Locations: 🇬🇧
The Christie NHS Foundation Trust, Manchester, United Kingdom

(CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)

Not yet recruiting

Conditions: Marginal Zone Lymphoma
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Peripheral T Cell Lymphoma
Diffuse Large B Cell Lymphoma
Richter Syndrome
Follicular Lymphoma

Interventions: Drug: Duvelisib

First Posted Date: 2023-06-28

Last Posted Date: 2023-10-23

Lead Sponsor: Ruijin Hospital

Target Recruit Count: 200

Registration Number: NCT05923502

A Study of Duvelisib Combined With SG001 Injection in Patient With Advanced Solid Tumors

Phase 1

Not yet recruiting

Conditions: Advanced Solid Tumors

Interventions: Drug: SG001
Drug: Duvelisib

First Posted Date: 2022-08-19

Last Posted Date: 2022-08-19

Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Target Recruit Count: 128

Registration Number: NCT05508659

Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy

Phase 1

Completed

Conditions: Non Hodgkin Lymphoma
Hodgkin Lymphoma
Myeloma
Lymphocytic Leukemia

Interventions: Drug: BMS-986345
Drug: Duvelisib

First Posted Date: 2021-10-04

Last Posted Date: 2025-05-06

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 14

Registration Number: NCT05065866

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC

Phase 2

Active, not recruiting

Conditions: Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Recurrent Squamous Cell Carcinoma of the Head and Neck
Metastatic Head and Neck Cancer
Advanced Head and Neck Cancer
Advanced Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Duvelisib
Drug: Docetaxel

First Posted Date: 2021-09-27

Last Posted Date: 2025-03-05

Lead Sponsor: Glenn J. Hanna

Target Recruit Count: 26

Registration Number: NCT05057247

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy

Phase 1

Recruiting

Conditions: Non-hodgkin Lymphoma
Acute Lymphocytic Leukemia

Interventions: Drug: Duvelisib

First Posted Date: 2021-09-14

Last Posted Date: 2024-11-05

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 43

Registration Number: NCT05044039

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

A Study of Ruxolitinib and Duvelisib in People With Lymphoma

Phase 1

Recruiting

Conditions: T-cell Lymphomas
NK-Cell Lymphomas
T-cell Prolymphocytic Leukemia
T-cell Large Granular Lymphocyte Leukemia

Interventions: Drug: Ruxolitinib
Drug: Duvelisib

First Posted Date: 2021-08-18

Last Posted Date: 2025-02-10

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 70

Registration Number: NCT05010005

Locations: 🇺🇸
University of Miami (Data Collection Only), Miami, Florida, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York, United States

and more 6 locations

Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study

Early Phase 1

Completed

Conditions: Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma

Interventions: Drug: Duvelisib
Biological: Tisagenlecleucel

First Posted Date: 2021-05-18

Last Posted Date: 2025-01-20

Lead Sponsor: Emory University

Target Recruit Count: 4

Registration Number: NCT04890236

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Acalabrutinib and Duvelisib for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Phase 1

Withdrawn

Conditions: Refractory Marginal Zone Lymphoma
Refractory Nodal Marginal Zone Lymphoma
Refractory Splenic Marginal Zone Lymphoma
Recurrent Follicular Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Nodal Marginal Zone Lymphoma
Recurrent Splenic Marginal Zone Lymphoma
Refractory Follicular Lymphoma
Refractory Indolent Non-Hodgkin Lymphoma

Interventions: Drug: Acalabrutinib
Drug: Duvelisib

First Posted Date: 2021-04-08

Last Posted Date: 2022-06-07

Lead Sponsor: Narendranath Epperla

Registration Number: NCT04836832

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