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

March 5, 2025 updated by: SecuraBio

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years of age

  2. 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

  3. 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
  4. For participants with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
  5. 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:

  1. 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
  2. Received prior allogeneic transplant
  3. Received prior treatment with a PI3K inhibitor
  4. Known central nervous system involvement by PTCL
  5. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) once daily
  6. Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening
  7. Known hypersensitivity to duvelisib and/or its excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID, administered in 28-day cycles.
Drug: Duvelisib
Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
Other Names:
  • IPI-145
Drug: Duvelisib
Duvelisib PO 75 mg BID in 28-day cycles.
Other Names:
  • IPI-145
Drug: Duvelisib
Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase).
Other Names:
  • IPI-145
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
Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
Other Names:
  • IPI-145
Drug: Duvelisib
Duvelisib PO 75 mg BID in 28-day cycles.
Other Names:
  • IPI-145
Drug: Duvelisib
Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase).
Other Names:
  • IPI-145
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
Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
Other Names:
  • IPI-145
Drug: Duvelisib
Duvelisib PO 75 mg BID in 28-day cycles.
Other Names:
  • IPI-145
Drug: Duvelisib
Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase).
Other Names:
  • IPI-145

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria
Time Frame: 56 days (2 cycles; 28-day cycles)
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.
56 days (2 cycles; 28-day cycles)
ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria
Time Frame: 56 days (2 cycles; 28-day cycles)
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.
56 days (2 cycles; 28-day cycles)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria
Time Frame: Up to 70 months
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.
Up to 70 months
Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria
Time Frame: Up to 70 months
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.
Up to 70 months
Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria
Time Frame: Up to 8 weeks
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.
Up to 8 weeks
DOR as Assessed by the IRC Using the Lugano Criteria
Time Frame: Up to 70 months
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.
Up to 70 months
PFS as Assessed by the IRC Using the Lugano Criteria
Time Frame: Up to 70 months
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.
Up to 70 months
DCR as Assessed by the IRC Using the Lugano Criteria
Time Frame: Up to 8 weeks
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.
Up to 8 weeks
Overall Survival (OS)
Time Frame: Up to 70 months
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.
Up to 70 months
Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)
Time Frame: Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles)
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).
Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SecuraBio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VS-0145-225
  • 2019-001123-13 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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