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

Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma

Phase 2

Recruiting

Conditions: Angioimmunoblastic T-cell Lymphoma
Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Enteropathy-Associated T-Cell Lymphoma
Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
Follicular T-Cell Lymphoma
Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
Peripheral T-Cell Lymphoma, Not Otherwise Specified

Interventions: Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Etoposide
Drug: Duvelisib
Drug: Oral azacitidine

First Posted Date: 2021-03-17

Last Posted Date: 2025-04-02

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 170

Registration Number: NCT04803201

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸
Cedars Sinai Medical Center, Los Angeles, California, United States
🇺🇸
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States

and more 77 locations

A Safety and Efficacy Study of Duvelisib in Relapsed/Refractory Follicular Lymphoma

Phase 2

Conditions: Follicular Lymphoma

Interventions: Drug: Duvelisib

First Posted Date: 2021-01-13

Last Posted Date: 2021-01-13

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

Target Recruit Count: 24

Registration Number: NCT04707079

Locations: 🇨🇳
Shanghai Ruijin Hospital, Shanghai, Shanghai, China

Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma

Phase 1

Active, not recruiting

Conditions: Unresectable Melanoma

Interventions: Drug: Nivolumab
Drug: Duvelisib

First Posted Date: 2020-12-30

Last Posted Date: 2024-08-09

Lead Sponsor: John Kirkwood

Target Recruit Count: 13

Registration Number: NCT04688658

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome

Phase 1

Active, not recruiting

Conditions: Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8
Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Duvelisib
Biological: Nivolumab
Procedure: Positron Emission Tomography
Procedure: Punch Biopsy

First Posted Date: 2020-12-04

Last Posted Date: 2025-03-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 38

Registration Number: NCT04652960

Locations: 🇺🇸
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States

and more 14 locations

Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

Phase 1

Withdrawn

Conditions: Adult T-cell Leukemia/Lymphoma
Extranodal NK-/T-cell Lymphoma, Nasal Type
Enteropathy-Associated T-Cell Lymphoma
Monomorphic Epiteliotrophic Intestinal T-cell Lymphoma
Hepatosplenic T-cell Lymphoma

Interventions: Drug: CC-486 (5-azacitidine)
Drug: Duvelisib
Drug: Romidepsin
Drug: Doxorubicin

First Posted Date: 2020-11-23

Last Posted Date: 2022-11-04

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT04639843

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19)

Phase 2

Completed

Conditions: COVID-19

Interventions: Drug: Placebo
Drug: Duvelisib

First Posted Date: 2020-07-27

Last Posted Date: 2023-04-07

Lead Sponsor: Emory University

Target Recruit Count: 47

Registration Number: NCT04487886

Locations: 🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital, Atlanta, Georgia, United States
🇺🇸
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

Duvelisib to Combat COVID-19

Phase 2

Completed

Conditions: COVID-19

Interventions: Drug: Duvelisib
Drug: Placebo
Procedure: Peripheral blood draw

First Posted Date: 2020-05-04

Last Posted Date: 2023-03-06

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 28

Registration Number: NCT04372602

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

Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL

Terminated

Conditions: Lymphoma, Small Lymphocytic
Lymphoma
Lymphoma, Non-Hodgkin
Chronic Lymphocytic Leukemia
Follicular Lymphoma

Interventions: Drug: PI3K inhibitor
Drug: duvelisib

First Posted Date: 2020-04-10

Last Posted Date: 2021-03-17

Lead Sponsor: SecuraBio

Target Recruit Count: 2

Registration Number: NCT04342117

Locations: 🇺🇸
CARTI Cancer Center, Little Rock, Arkansas, United States
🇺🇸
Joliet Oncology-Hematology Associates, LTD, Joliet, Illinois, United States
🇺🇸
McFarland Clinic,PC, Ames, Iowa, United States

and more 8 locations