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Completed

NCT Number: NCT03372057

A Study of Duvelisib in Participants 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).

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Key information

Conditions

Peripheral T-cell Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinikum Carl Gustav Carus, Dresden, Saxony, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Peripheral T-cell lymphoma-not otherwise specified;
  • Angioimmunoblastic T-cell lymphomas;
  • Anaplastic large cell lymphoma (ALCL); or
  • Natural-killer/T-cell lymphoma
  • 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)

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

Treatment and study plan

Duvelisib

Drug

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

Other names: IPI-145

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

Sponsors and collaborators

Lead sponsor

SecuraBio

Industry

Registry information

Official study 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)

Acronym: PRIMO

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2017
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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