Clinical Trials

Numerous clinical trials evaluate IPI-145 (Duvelisib) from Early Phase 1 through Phase 3, with statuses ranging from completed studies to actively recruiting trials testing novel combination regimens. Sponsored by industry partners like SecuraBio and AbbVie alongside cooperative networks such as the National Cancer Institute and the Alliance for Clinical Trials in Oncology, research primarily targets hematologic malignancies, including chronic lymphocytic leukemia, small lymphocytic lymphoma, peripheral T-cell lymphoma, mycosis fungoides, and Sezary syndrome. Additional studies evaluate its utility in rheumatoid arthritis, unresectable melanoma, and hepatic impairment.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07001384 RECRUITING
Anaplastic Lymphoma Kinase; Anaplastic Large Cell Lymphoma
Memorial Sloan Kettering Cancer Center
 2025-08-08 PHASE1
NCT06810778 RECRUITING
T-cell-prolymphocytic Leukemia; Cutaneous T-Cell Lymphoma Refractory
Jonsson Comprehensive Cancer Center
 2025-05-02 PHASE1; PHASE2
NCT07714187 NOT_YET_RECRUITING
Mycosis Fungoides; Cutaneous T-cell Lymphoma
SecuraBio
 2027-01 PHASE1
NCT06522737 RECRUITING
Lymphoma
SecuraBio
 2025-05-19 PHASE3
NCT07293403 RECRUITING
Follicular Helper T-Cell Lymphoma; Peripheral T-Cell Lymphoma, Not Otherwise Specified
City of Hope Medical Center
 2026-10-01 PHASE2
NCT05010005 RECRUITING
T-cell Lymphomas; NK-Cell Lymphomas; T-cell Prolymphocytic Leukemia; T-cell Large Granular Lymphocyte Leukemia
Memorial Sloan Kettering Cancer Center
 2021-08-12 PHASE1
NCT04803201 RECRUITING
Angioimmunoblastic T-cell Lymphoma; Enteropathy-Associated T-Cell Lymphoma; Follicular T-Cell Lymphoma; Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma; Nodal Peripheral T-Cell Lymphoma With TFH Phenotype; Peripheral T-Cell Lymphoma, Not Otherwise Specified
Alliance for Clinical Trials in Oncology
 2021-10-08 PHASE2
NCT04652960 ACTIVE_NOT_RECRUITING
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8
National Cancer Institute (NCI)
 2021-10-21 PHASE1
NCT05976997 RECRUITING
Newly Diagnosed Peripheral T-cell Lymphoma
Liling Zhang
 2023-05-08 PHASE2
NCT05675813 RECRUITING
Peripheral T Cell Lymphoma
Ruijin Hospital
 2023-02-13 PHASE1; PHASE2
NCT04331119 TERMINATED
T-Cell Lymphoma
Washington University School of Medicine
 2020-07-23 PHASE2
NCT02783625 COMPLETED
Lymphoma; Relapsed/Refractory T-cell Lymphomas
Memorial Sloan Kettering Cancer Center
 2016-05-23 PHASE1
NCT05044039 ACTIVE_NOT_RECRUITING
Non-hodgkin Lymphoma; Acute Lymphocytic Leukemia
Washington University School of Medicine
 2022-02-28 PHASE1
NCT03534323 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia; Richter Syndrome
Dana-Farber Cancer Institute
 2018-07-12 PHASE1; PHASE2
NCT05508659 UNKNOWN
Advanced Solid Tumors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2022-09-20 PHASE1; PHASE2
NCT04890236 COMPLETED
Recurrent Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma
Emory University
 2022-01-13 EARLY_PHASE1
NCT04688658 TERMINATED
Unresectable Melanoma
John Kirkwood
 2021-10-06 PHASE1; PHASE2
NCT03892044 COMPLETED
Chronic Lymphocytic Leukemia; Recurrent Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Richter Syndrome; Small Lymphocytic Lymphoma; Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma; Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma; Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma
David Bond, MD
 2019-11-05 PHASE1
NCT05065866 COMPLETED
Non Hodgkin Lymphoma; Hodgkin Lymphoma; Myeloma; Lymphocytic Leukemia
H. Lee Moffitt Cancer Center and Research Institute
 2021-11-18 PHASE1
NCT04836832 WITHDRAWN
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; Refractory Marginal Zone Lymphoma; Refractory Nodal Marginal Zone Lymphoma; Refractory Splenic Marginal Zone Lymphoma
Narendranath Epperla
 2022-07-01 PHASE1
NCT03372057 COMPLETED
Peripheral T-cell Lymphoma
SecuraBio
 2018-02-22 PHASE2
NCT05057247 COMPLETED
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
Glenn J. Hanna
 2021-10-14 PHASE2
NCT03961672 ACTIVE_NOT_RECRUITING
Recurrent Chronic Lymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Small Lymphocytic Lymphoma
City of Hope Medical Center
 2020-05-13 PHASE2
NCT04038359 COMPLETED
Indolent Non-Hodgkin Lymphoma
SecuraBio
 2019-09-24 PHASE2
NCT04639843 WITHDRAWN
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
National Cancer Institute (NCI)
 2022-11-03 PHASE1
NCT04372602 COMPLETED
COVID-19
Washington University School of Medicine
 2020-10-12 PHASE2
NCT04707079 UNKNOWN
Follicular Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2019-12-18 PHASE2
NCT04487886 COMPLETED
COVID-19
Emory University
 2020-11-18 PHASE2
NCT04209621 TERMINATED
Small Lymphocytic Leukemia (SLL); Chronic Lymphocytic Leukemia (CLL)
National Heart, Lung, and Blood Institute (NHLBI)
 2020-07-31 PHASE2
NCT04193293 TERMINATED
Head and Neck Squamous Cell Carcinoma
SecuraBio
 2020-06-01 PHASE1; PHASE2
NCT01882803 COMPLETED
Indolent Non-Hodgkin Lymphoma
SecuraBio
 2013-06-17 PHASE2
NCT02049515 COMPLETED
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
SecuraBio
 2013-12 PHASE3
NCT03370185 WITHDRAWN
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
SecuraBio
 2018-02-12 PHASE2
NCT02711852 COMPLETED
Hematologic Malignancy
SecuraBio
 2016-04 PHASE2
NCT02640833 WITHDRAWN
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Non-Hodgkin Lymphoma
AbbVie
 2016-07 PHASE1
NCT02158091 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia
Dana-Farber Cancer Institute
 2014-06-27 PHASE1; PHASE2
NCT02004522 COMPLETED
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
SecuraBio
 2013-11 PHASE3
NCT02391545 TERMINATED
CD20+ Follicular Lymphoma
SecuraBio
 2014-12 PHASE1; PHASE2
NCT02598570 COMPLETED
Lymphoma
AbbVie
 2015-11 PHASE1
NCT01476657 TERMINATED
Hematologic Malignancies
SecuraBio
 2011-10 PHASE1
NCT02204982 TERMINATED
Follicular Lymphoma
SecuraBio
 2014-09 PHASE3
NCT02028039 WITHDRAWN
Leukemia
M.D. Anderson Cancer Center
 2013-12 PHASE2
NCT02576275 WITHDRAWN
Indolent Non-Hodgkin's Lymphoma; Follicular Lymphoma; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma
SecuraBio
 2015-12 PHASE3
NCT02605694 WITHDRAWN
Lymphoma
SecuraBio
 2015-12 PHASE2
NCT02292225 TERMINATED
Lymphocytic Leukemia, Chronic; Lymphoma, Small Lymphocytic
SecuraBio
 2015-02 PHASE1
NCT01871675 COMPLETED
Lymphoma; Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma; T-cell Lymphoma
SCRI Development Innovations, LLC
 2013-05 PHASE1
NCT02307461 COMPLETED
Healthy
SecuraBio
 2014-11 PHASE1
NCT01851707 COMPLETED
Rheumatoid Arthritis
SecuraBio
 2013-04 PHASE2
NCT02307461 Completed
Healthy
SecuraBio
 2014-11 Phase 1
NCT01653756 COMPLETED
Asthma
SecuraBio
 2012-07 PHASE2
NCT02095587 COMPLETED
Hepatic Impairment
SecuraBio
 2014-03 PHASE1
NCT02095587 Completed
Hepatic Impairment
SecuraBio
 2014-03 Phase 1
NCT01947777 COMPLETED
Healthy
SecuraBio
 2013-10 PHASE1
NCT01947777 Completed
Healthy
SecuraBio
 2013-10 Phase 1
NCT01925911 COMPLETED
Healthy
SecuraBio
 2013-08 PHASE1
NCT01925911 Completed
Healthy
SecuraBio
 2013-08 Phase 1
NCT01836861 COMPLETED
Healthy
SecuraBio
 2013-03 PHASE1
NCT01836861 Completed
Healthy
SecuraBio
 2013-03 Phase 1
NCT01549106 COMPLETED
Healthy Volunteers
SecuraBio
 2011-08 PHASE1
NCT01549106 Completed
Healthy Volunteers
SecuraBio
 2011-08 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-05-26)

Check the IPI-145 (Duvelisib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Duvelisib (IPI-145) acts as a potent, isoform-selective inhibitor of phosphoinositide 3-kinase (PI3K) delta and gamma, thereby blocking downstream AKT phosphorylation and cellular survival pathways. By disrupting these downstream signaling cascades, the compound suppresses immune cell activation and induces apoptosis in malignant B and T lymphocytes, demonstrating clinical relevance in trials for chronic lymphocytic leukemia, small lymphocytic lymphoma, and peripheral T-cell lymphomas.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.