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Peripheral T-cell LymphomaPhase 2PRIMONCT03372057

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

A Phase 2 study testing Duvelisib in people with Peripheral T-cell Lymphoma, run by SecuraBio at 36 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral T-cell Lymphoma
What is being tested?
Duvelisib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
36 sitesin 5 countries
Study dates
22 Feb 2018to 22 Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years of age
  • Diagnosis of one of the following histologic subtypes of PTCL, pathologically confirmed, as defined by the World Health Organization:
  • Peripheral T-cell lymphoma-not otherwise specified;
  • Angioimmunoblastic T-cell lymphomas;
  • Anaplastic large cell lymphoma (ALCL); or
  • Natural-killer/T-cell lymphoma
Show all 12Show fewer
  • Received at least 2 cycles of one standard regimen for newly diagnosed advanced PTCL, and one of the following:
  • failed to achieve at least a PR after 2 or more cycles of standard therapy;
  • failed to achieve a CR after completion of standard therapy; and/or
  • 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)

Who cannot join

  • 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

Trial locations and contacts

36 sites in 5 countries.

36 sites in 5 countries

United States19 sites

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 20742

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Novant Health

    Charlotte, North Carolina, 28204

  • Northwestern University - Feinberg School of Medicine

    Chicago, Illinois, 60611

  • The Ohio State University

    Columbia, Ohio, 43202

  • Baylor Research Institute - Charles Sammons Cancer Center

    Dallas, Texas, 75246

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University

    Durham, North Carolina, 27710

  • University of California - Irvine

    Irvine, California, 92691

  • University of California - Los Angeles

    Los Angeles, California, 90404

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • University of Rochester

    Rochester, New York, 14627

  • Washington University

    St Louis, Missouri, 63110

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

  • Toledo Cancer Center

    Toledo, Ohio, 43623

Other trials in United States

Japan8 sites

  • Japanese Site 8

    Fukuoka

  • Japanese Site 5

    Kobe

  • Japanese Site 3

    Miyagi

  • Japanese Site 6

    Nagoya

  • Japanese Site 7

    Niigata

  • Japanese Site 1

    Okayama

  • Japanese Site 2

    Tokyo

  • Japanese Site 4

    Tokyo

Other trials in Japan

Italy5 sites

  • ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo

    Bergamo, 24127

  • A.O.di Bologna Policl.S.Orsola

    Bologna, 40138

  • Ieo, Irccs

    Milan, 20141

  • Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore

    Roma, 00168

  • Azienda Ospedaliera Santa Maria di Terni

    Terni, 05100

Other trials in Italy

Germany2 sites

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Saxony, 01307

  • Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV

    Halle, Saxony-Anhalt, 06120

Other trials in Germany

United Kingdom2 sites

  • Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

Other trials in United Kingdom

About this study

Official title: A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

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.

Being tested
Duvelisib
Keywords
Lymphoma, T-cell Lymphoma, Relapse, Refractory, PI3K-δ,γ
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, Lymphoma, T-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DuvelisibDrug

    Also called IPI-145

    Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.

  • DuvelisibDrug

    Also called IPI-145

    Duvelisib PO 75 mg BID in 28-day cycles.

  • DuvelisibDrug

    Also called IPI-145

    Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase).

Study groups in NCT03372057
Study groupRoleWhat they receive
Dose Optimization Phase: Cohort 1ExperimentalDuvelisib 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.
Receives: Drug: Duvelisib
Dose Optimization Phase: Cohort 2ExperimentalDuvelisib 75 mg PO BID, administered in 28-day cycles.
Receives: Drug: Duvelisib
Expansion PhaseExperimentalDuvelisib 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).
Receives: Drug: Duvelisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 56 days (2 cycles; 28-day cycles)

  2. 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.

    Measured: 56 days (2 cycles; 28-day cycles)

Secondary outcomes (8)

  1. 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.

    Measured: Up to 70 months

  2. 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.

    Measured: Up to 70 months

  3. 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.

    Measured: Up to 8 weeks

  4. 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.

    Measured: Up to 70 months

  5. 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.

    Measured: Up to 70 months

  6. 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.

    Measured: Up to 8 weeks

  7. 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.

    Measured: Up to 70 months

  8. 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).

    Measured: Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2017
  2. Study start22 Feb 2018
  3. Primary completion22 Dec 2023
  4. Study completion22 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03372057
Sponsor's protocol ID
VS-0145-225
Other IDs
2019-001123-13, 2019
Acronym
PRIMO
Status last verified
Mar 2025
First submitted
1 Dec 2017
Last updated
7 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Mehta-Shah N, Zinzani PL, Jacobsen ED, Zain J, Mead M, Casulo C, Gritti G, Pinter-Brown L, Izutsu K, Sidransky D, Bentur OS, Pro B, Fox CP, Brammer JE, Horwitz SM. Duvelisib Induces Deep Responses in Peripheral T-Cell Lymphoma: Final Results of the Phase II PRIMO Trial of Duvelisib in Relapsed/Refractory Peripheral T-Cell Lymphoma. J Clin Oncol. 2026 Jul 10;44(20):1889-1898. doi: 10.1200/JCO-25-03120. Epub 2026 Apr 22.

    PubMed 42018969

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Duvelisib in people with Peripheral T-cell Lymphoma, run by SecuraBio at 36 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Japan, Italy, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria (time frame: 56 days (2 cycles; 28-day cycles)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03372057, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.

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