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NCT03372057 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2025-03-07

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

DOR as Assessed by the IRC Using the Lugano Criteria

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outcome · POSTED

PFS as Assessed by the IRC Using the Lugano Criteria

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outcome · POSTED

DCR as Assessed by the IRC Using the Lugano Criteria

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Duvelisib
    label
    Dose Optimization Phase: Cohort 1
    type
    EXPERIMENTAL
  2. description
    Duvelisib 75 mg PO BID, administered in 28-day cycles.
    intervention Names
    1. Drug: Duvelisib
    label
    Dose Optimization Phase: Cohort 2
    type
    EXPERIMENTAL
  3. description
    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).
    intervention Names
    1. Drug: Duvelisib
    label
    Expansion Phase
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dose Optimization Phase: Cohort 1
    description
    Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
    name
    Duvelisib
    other Names
    1. IPI-145
    type
    DRUG
  2. arm Group Labels
    1. Dose Optimization Phase: Cohort 2
    description
    Duvelisib PO 75 mg BID in 28-day cycles.
    name
    Duvelisib
    other Names
    1. IPI-145
    type
    DRUG
  3. arm Group Labels
    1. Expansion Phase
    description
    Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase).
    name
    Duvelisib
    other Names
    1. IPI-145
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
156
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria
    time Frame
    56 days (2 cycles; 28-day cycles)
  2. description
    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.
    measure
    ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria
    time Frame
    56 days (2 cycles; 28-day cycles)
secondary Outcomes
  1. description
    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.
    measure
    Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria
    time Frame
    Up to 70 months
  2. description
    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.
    measure
    Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria
    time Frame
    Up to 70 months
  3. description
    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.
    measure
    Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria
    time Frame
    Up to 8 weeks
  4. description
    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.
    measure
    DOR as Assessed by the IRC Using the Lugano Criteria
    time Frame
    Up to 70 months
  5. description
    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.
    measure
    PFS as Assessed by the IRC Using the Lugano Criteria
    time Frame
    Up to 70 months
  6. description
    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.
    measure
    DCR as Assessed by the IRC Using the Lugano Criteria
    time Frame
    Up to 8 weeks
  7. description
    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.
    measure
    Overall Survival (OS)
    time Frame
    Up to 70 months
  8. description
    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).
    measure
    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)
Full study description
brief 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).
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.
Source references
references
  1. citation
    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.
    pmid
    42018969
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
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      query cond
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      query disease state id
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      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
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    Preserved source evidence · Not medical advice