Clinical Trials /

A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)

NCT03372057

Description:

This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of PI3K-δ,γ, in patients with relapsed or refractory Peripheral T cell Lymphoma (PTCL).

Related Conditions:
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-Cell Lymphoma
  • Natural Killer Cell Lymphoblastic Leukemia/Lymphoma
  • Peripheral T-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: VS-0145-225
  • NCT ID: NCT03372057

Conditions

  • Peripheral T-cell Lymphoma

Interventions

DrugSynonymsArms
DuvelisibDose Optimization Phase: Cohort 1
DuvelisibDose Optimization Phase: Cohort 2
DuvelisibExpansion Phase

Purpose

This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of PI3K-δ,γ, in patients with relapsed or refractory Peripheral T cell Lymphoma (PTCL).

Detailed Description

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

      In the Dose Optimization Phase, patients will be randomly assigned to 1 of 2 study cohorts,
      as follows:

        -  Cohort 1: Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a
           per-patient basis to 50 mg and then 75 mg, based on the patient'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 patients will be enrolled in the Dose Optimization Phase, with 10 patients per
      cohort. Based on the safety and activity data obtained in the Dose Optimization Phase of the
      study, the Expansion Phase dose of Duvelisib will be determined.

      In the Expansion Phase, approximately 90-100 patients may be enrolled and will receive
      Duvelisib dose in 28-day cycles as determined in Dose Optimization Phase.
    

Trial Arms

NameTypeDescriptionInterventions
Dose Optimization Phase: Cohort 1ExperimentalDuvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-patient basis to 50 mg and then 75 mg, based on the patient's response to and tolerance of therapy, in 28-day cycles.
  • Duvelisib
Dose Optimization Phase: Cohort 2ExperimentalDuvelisib 75 mg PO BID, administered in 28-day cycles.
  • Duvelisib
Expansion PhaseExperimentalDuvelisib administered in 28-day cycles (dose determined in Optimization Phase)
  • Duvelisib

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 (PTCL-NOS);

               2. Angioimmunoblastic T-cell lymphomas (AITL);

               3. Anaplastic large cell lymphoma (ALCL); or

               4. Natural-killer/T-cell lymphoma (NKTL)

          3. Received at least 2 cycles of one prior regimen administered with curative intent and
             one of the following:

               1. failed to achieve at least a partial response after 2 or more cycles;

               2. failed to achieve a complete response after 6 or more cycles; and/or

               3. progressed after an initial response

          4. For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab
             vedotin

          5. Measurable disease as defined by IWG for PTCL, i.e., at least 1 measurable disease
             lesion > 1.5 cm in at least one dimension by 18FDG-PET-CT, MRI, or diagnostic CT

        Exclusion Criteria:

          1. Clinical evidence of transformation to a more aggressive subtype of lymphoma

          2. Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor

          3. Known central nervous system involvement by PTCL

          4. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic
             steroids > 20 mg of prednisone (or equivalent) once daily (QD)

          5. Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:From start of treatment to first documented response, assessed up to 2 cycles (58 days)
Safety Issue:
Description:Best response of CR or PR

Secondary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:From start of treatment until disease progression or unacceptable toxicity, assessed up to 2 cycles (58 days)
Safety Issue:
Description:
Measure:Number of participants with Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0
Time Frame:From start of treatment to end of treatment plus 30 days; 7 months
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:Time from the first documentation of response to first documentation of progressive disease or death due to any cause, 6 months
Safety Issue:
Description:
Measure:Progression-free survival (PFS)
Time Frame:Time from start of treatment to first documentation of progression or date of death from any cause, whichever came first, 4 months
Safety Issue:
Description:
Measure:Disease control rate (DCR)
Time Frame:Greater than or equal to 8 weeks
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:From start of treatment until death, 6 months
Safety Issue:
Description:
Measure:Percentage of patients who receive the optimal dose of duvelisib
Time Frame:From start of treatment to end of cycle 1 (each cycle is 28 days)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Verastem, Inc.

Trial Keywords

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

Last Updated

October 18, 2019