CompletedNCT03372057PRIMOUpdated Mar 7, 2025Results posted

A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

A Phase 2 interventional study of Duvelisib and Duvelisib in Peripheral T-cell Lymphoma, sponsored by SecuraBio. Completed at 36 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by SecuraBio · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 156
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of phosphoinositide-3-kinase-delta, gamma (PI3K-δ,γ), in participants with relapsed/refractory peripheral T-cell lymphoma (PTCL).

Read the detailed description

The study had 2 phases, a Dose Optimization Phase and an Expansion Phase.

In the Dose Optimization Phase, participants were randomly assigned to 1 of 2 study cohorts, as follows:

Cohort 1: Duvelisib per oral (PO) twice daily (BID) at a starting dose of 25 milligrams (mg), with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
Cohort 2: Duvelisib 75 mg PO BID, administered in 28-day cycles.

A total of 20 participants were to be enrolled in the Dose Optimization Phase, with 10 participants per cohort. Based on the safety and activity data obtained in the Dose Optimization Phase of the study, the Expansion Phase dose of duvelisib was to be determined.

In the Expansion Phase, approximately 100-130 participants were to be enrolled and receive duvelisib dose in 28-day cycles as determined in Dose Optimization Phase.

Conditions studied

Peripheral T-cell Lymphoma

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Keywords

Lymphoma
T-cell Lymphoma
Relapse
Refractory
PI3K-δ,γ

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age ≥ 18 years of age
Diagnosis of one of the following histologic subtypes of PTCL, pathologically confirmed, as defined by the World Health Organization:
1. Peripheral T-cell lymphoma-not otherwise specified;
2. Angioimmunoblastic T-cell lymphomas;
3. Anaplastic large cell lymphoma (ALCL); or
4. Natural-killer/T-cell lymphoma
Received at least 2 cycles of one standard regimen for newly diagnosed advanced PTCL, and one of the following:
1. failed to achieve at least a PR after 2 or more cycles of standard therapy;
2. failed to achieve a CR after completion of standard therapy; and/or
3. persistent or progressive disease after an initial response
For participants with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
Measurable disease as defined by Lugano for PTCL, that is, at least 1 measurable disease lesion > 1.5 centimeters in at least one dimension by conventional techniques (fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography [CT], CT with contrast, magnetic imaging resonance)

Exclusion criteria

Exclusion Criteria:

Primary leukemic PTCL subtypes (that is, T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, adult T-cell leukemia/lymphoma and aggressive NK-cell leukemia) or transformed mycosis fungoides
Received prior allogeneic transplant
Received prior treatment with a PI3K inhibitor
Known central nervous system involvement by PTCL
Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) once daily
Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening
Known hypersensitivity to duvelisib and/or its excipients

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 156 participants (actual)

Study arms

Experimental
Dose Optimization Phase: Cohort 1
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
Drug: Duvelisib
Experimental
Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID, administered in 28-day cycles.
Drug: Duvelisib
Experimental
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with complete response (CR), partial response (PR) or stable disease (SD), in 28-day cycles (dose determined in Optimization Phase).
Drug: Duvelisib

Interventions

DrugDuvelisib
Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
Also known as: IPI-145
DrugDuvelisib
Duvelisib PO 75 mg BID in 28-day cycles.
Also known as: IPI-145
DrugDuvelisib
Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase).
Also known as: IPI-145

What researchers measure

Primary outcomes

Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria
ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.
Time frame: 56 days (2 cycles; 28-day cycles)
ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria
ORR was defined as the percentage of participants with CR + PR, as assessed by the IRC using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.
Time frame: 56 days (2 cycles; 28-day cycles)

Secondary outcomes

Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria
DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of progressive disease (PD) or death due to any cause. Participants who withdraw from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.
Time frame: Up to 70 months
Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria
PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first.
Time frame: Up to 70 months
Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria
DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of stable disease (SD) sustained for at least 8 weeks.
Time frame: Up to 8 weeks
DOR as Assessed by the IRC Using the Lugano Criteria
DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of PD or death due to any cause. Participants who withdrew from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.
Time frame: Up to 70 months
PFS as Assessed by the IRC Using the Lugano Criteria
PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first.
Time frame: Up to 70 months
DCR as Assessed by the IRC Using the Lugano Criteria
DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of SD sustained for at least 8 weeks.
Time frame: Up to 8 weeks
Overall Survival (OS)
OS was defined as the time from the date of first treatment to the date of death due to any cause. Participants without documented death were censored at last alive date.
Time frame: Up to 70 months
Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)
Blood samples were taken for the analyses of duvelisib and IPI-656 in plasma at designated time points. Results are reported as nanograms/milliliter (ng/mL).
Time frame: Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles)

Results

Posted Feb 28, 2025

Participant flow

Regardless of study phase, all participants underwent screening assessments up to 30 days before the first study drug dose.

Dose Optimization Phase

Participant flow — Dose Optimization Phase
Milestone	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2
Started	20	13
Received at least 1 dose of study drug	20	13
Completed	0	0
Not completed	20	13
Withdrew: Withdrawal by subject	1	1
Withdrew: Closure of the study by the sponsor	3	1
Withdrew: Death	16	11

Expansion Phase

Participant flow — Expansion Phase
Milestone	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2	Expansion Phase
Started	0	0	123
Received at least 1 dose of study drug	0	0	123
Completed	0	0	0
Not completed	0	0	123
Withdrew: Withdrawal by subject	0	0	4
Withdrew: Closure of the study by the sponsor	0	0	39
Withdrew: Death	0	0	78
Withdrew: Progressive disease	0	0	1
Withdrew: Adverse event	0	0	1

Outcome measures

PrimaryOverall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria

ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.

Time frame:: 56 days (2 cycles; 28-day cycles)
Reported as:: Number · percentage of participants

Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria
percentage of participants	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2
Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria	53.8 (26.7 to 80.9)	53.8 (26.7 to 80.9)

PrimaryORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria

ORR was defined as the percentage of participants with CR + PR, as assessed by the IRC using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.

Time frame:: 56 days (2 cycles; 28-day cycles)
Reported as:: Number · percentage of participants

ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria
percentage of participants	Expansion Phase
ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria	48.0 (39.1 to 56.8)

SecondaryDuration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria

DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of progressive disease (PD) or death due to any cause. Participants who withdraw from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.

Time frame:: Up to 70 months
Reported as:: Median · month

Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria
month	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2
Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria	4.22 (1.87 to NA)	3.32 (1.77 to NA)

SecondaryProgression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria

PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first.

Time frame:: Up to 70 months
Reported as:: Median · month

Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria
month	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2
Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria	3.55 (1.05 to 8.54)	3.55 (1.81 to 13.14)

SecondaryDisease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria

DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of stable disease (SD) sustained for at least 8 weeks.

Time frame:: Up to 8 weeks
Reported as:: Number · percentage of participants

Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria
percentage of participants	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2
Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria	61.5 (35.1 to 88.0)	61.5 (35.1 to 88.0)

SecondaryDOR as Assessed by the IRC Using the Lugano Criteria

DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of PD or death due to any cause. Participants who withdrew from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.

Time frame:: Up to 70 months
Reported as:: Median · month

DOR as Assessed by the IRC Using the Lugano Criteria
month	Expansion Phase
DOR as Assessed by the IRC Using the Lugano Criteria	7.9 (6.4 to 21.00)

SecondaryPFS as Assessed by the IRC Using the Lugano Criteria

PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first.

Time frame:: Up to 70 months
Reported as:: Median · months

PFS as Assessed by the IRC Using the Lugano Criteria
months	Expansion Phase
PFS as Assessed by the IRC Using the Lugano Criteria	3.4 (1.8 to 3.9)

SecondaryDCR as Assessed by the IRC Using the Lugano Criteria

DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of SD sustained for at least 8 weeks.

Time frame:: Up to 8 weeks
Reported as:: Number · percentage of participants

DCR as Assessed by the IRC Using the Lugano Criteria
percentage of participants	Expansion Phase
DCR as Assessed by the IRC Using the Lugano Criteria	49.6 (40.8 to 58.4)

SecondaryOverall Survival (OS)

OS was defined as the time from the date of first treatment to the date of death due to any cause. Participants without documented death were censored at last alive date.

Time frame:: Up to 70 months
Reported as:: Median · month

Overall Survival (OS)
month	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2	Expansion Phase
Overall Survival (OS)	6.70 (5.22 to NA)	10.58 (6.67 to 44.62)	12.4 (8.4 to 22.7)

SecondaryPlasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)

Blood samples were taken for the analyses of duvelisib and IPI-656 in plasma at designated time points. Results are reported as nanograms/milliliter (ng/mL).

Time frame:: Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles)
Reported as:: Mean · ng/mL

Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)
ng/mL	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2	Expansion Phase
Duvelisib: Cycle 1, Day 15	1238.1 ± 787.53	2070.0 ± 889.39	2873.7 ± 1709.15
Duvelisib: Cycle 2, Day 15	1492.5 ± 1019.10	—	2648.2 ± 1336.94
Metabolite (IPI-156): Cycle 1, Day 15	1310.4 ± 1408.99	1580.9 ± 772.13	2387.5 ± 1919.33
Metabolite (IPI-156): Cycle 2, Day 15	894.8 ± 441.55	—	2427.0 ± 1655.89

Adverse events

Collected over From start of treatment (Day 1) to end of study (70 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dose Optimization Phase: Cohort 1	16/20 (80%)	14/20 (70%)	19/20 (95%)
Dose Optimization Phase: Cohort 2	11/13 (84.6%)	9/13 (69.2%)	13/13 (100%)
Expansion Phase	78/123 (63.4%)	60/123 (48.8%)	121/123 (98.4%)

Most frequent serious events

Showing 10 of 86

Most frequent serious events
Event	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2	Expansion Phase
PyrexiaGeneral disorders	1/20	3/13	6/123
PneumoniaInfections and infestations	4/20	0/13	4/123
DiarrhoeaGastrointestinal disorders	1/20	2/13	9/123
ColitisGastrointestinal disorders	1/20	2/13	2/123
Disease progressionGeneral disorders	3/20	0/13	10/123
SepsisInfections and infestations	3/20	1/13	3/123
Aspartate aminotransferase increasedInvestigations	2/20	0/13	3/123
Respiratory failureRespiratory, thoracic and mediastinal disorders	2/20	1/13	1/123
DyspnoeaRespiratory, thoracic and mediastinal disorders	2/20	1/13	0/123
Febrile neutropeniaBlood and lymphatic system disorders	0/20	1/13	2/123

Most frequent other events

Showing 10 of 130

Most frequent other events
Event	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2	Expansion Phase
DiarrhoeaGastrointestinal disorders	9/20	9/13	41/123
Platelet count decreasedInvestigations	11/20	6/13	34/123
Alanine aminotransferase increasedInvestigations	4/20	7/13	47/123
NauseaGastrointestinal disorders	9/20	6/13	31/123
FatigueGeneral disorders	7/20	6/13	38/123
PyrexiaGeneral disorders	6/20	6/13	28/123
Neutrophil count decreasedInvestigations	8/20	3/13	41/123
AnaemiaBlood and lymphatic system disorders	7/20	5/13	34/123
Aspartate aminotransferase increasedInvestigations	4/20	5/13	45/123
White blood cell count decreasedInvestigations	7/20	3/13	25/123

Baseline characteristics

Safety Analysis Set: all participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2	Expansion Phase	Total
Mean	64.0 ± 14.81	65.0 ± 7.22	62.9 ± 13.59	63.2 ± 13.29

Sex: Female, Male
Sex: Female, Male(Participants)	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2	Expansion Phase	Total
Female	6	4	56	66
Male	14	9	67	90

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2	Expansion Phase	Total
Hispanic or Latino	2	0	12	14
Not Hispanic or Latino	18	12	111	141
Unknown or Not Reported	0	1	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2	Expansion Phase	Total
American Indian or Alaska Native	0	0	0	0
Asian	1	1	18	20
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	2	0	9	11
White	16	12	92	120
More than one race	0	0	0	0
Unknown or Not Reported	1	0	4	5

Eastern Cooperative Oncology Group (ECOG) Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status(participants)	Dose Optimization Phase: Cohort 1	Dose Optimization Phase: Cohort 2	Expansion Phase	Total
0	8	5	49	62
1	8	7	64	79
2	3	1	10	14
3	0	0	0	0
4	0	0	0	0
5	0	0	0	0
Missing	1	0	0	1

Study locations

36 sites

City of Hope National Medical Center
Duarte, California 91010, United States
University of California - Irvine
Irvine, California 92691, United States
University of California - Los Angeles
Los Angeles, California 90404, United States
Emory University Winship Cancer Institute
Atlanta, Georgia 30322, United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois 60611, United States
Norton Cancer Institute
Louisville, Kentucky 40207, United States
University of Maryland
Baltimore, Maryland 20742, United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215, United States
Washington University
Saint Louis, Missouri 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York 10021, United States
University of Rochester
Rochester, New York 14627, United States
Stony Brook Cancer Center
Stony Brook, New York 11794, United States
Levine Cancer Institute
Charlotte, North Carolina 28204, United States
Novant Health
Charlotte, North Carolina 28204, United States
Duke University
Durham, North Carolina 27710, United States
The Ohio State University
Columbia, Ohio 43202, United States
Toledo Cancer Center
Toledo, Ohio 43623, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232, United States
Baylor Research Institute - Charles Sammons Cancer Center
Dallas, Texas 75246, United States
Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV
Halle, Sachsen-Anhalt 06120, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen 01307, Germany
ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo
Bergamo, 24127, Italy
A.O.di Bologna Policl.S.Orsola
Bologna, 40138, Italy
Ieo, Irccs
Milano, 20141, Italy
Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore
Roma, 00168, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, 05100, Italy
Japanese Site 8
Fukuoka, Japan
Japanese Site 5
Kobe, Japan
Japanese Site 3
Miyagi, Japan
Japanese Site 6
Nagoya, Japan
Japanese Site 7
Niigata, Japan
Japanese Site 1
Okayama, Japan
Japanese Site 2
Tokyo, Japan
Japanese Site 4
Tokyo, Japan
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom

References and documents

Study documents

Study protocol · Nov 24, 2021
Statistical analysis plan · Aug 7, 2023

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03372057
Lead sponsor: SecuraBio
Responsible party: Sponsor
First posted: Dec 13, 2017
Start date: Feb 22, 2018
Primary completion: Dec 22, 2023
Completion: Dec 22, 2023
Results posted: Feb 28, 2025
Last update: Mar 7, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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