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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372057
Recruitment Status : Active, not recruiting
First Posted : December 13, 2017
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
SecuraBio

Tracking Information
First Submitted Date  ICMJE December 1, 2017
First Posted Date  ICMJE December 13, 2017
Last Update Posted Date May 18, 2021
Actual Study Start Date  ICMJE February 22, 2018
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
Objective response rate (ORR) [ Time Frame: From start of treatment to first documented response, assessed up to 2 cycles (58 days) ]
Best response of CR or PR
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • Overall response rate (ORR) [ Time Frame: From start of treatment until disease progression or unacceptable toxicity, assessed up to 2 cycles (58 days) ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Disease control rate (DCR) [ Time Frame: Greater than or equal to 8 weeks ]
  • Overall survival (OS) [ Time Frame: From start of treatment until death, 6 months ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
Official Title  ICMJE 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)
Brief Summary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral T-cell Lymphoma
Intervention  ICMJE
  • Drug: Duvelisib
    Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
  • Drug: Duvelisib
    Duvelisib PO 75 mg BID in 28-day cycles.
  • Drug: Duvelisib
    Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase)
Study Arms  ICMJE
  • Experimental: Dose Optimization Phase: 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.
    Intervention: Drug: Duvelisib
  • Experimental: Dose Optimization Phase: Cohort 2
    Duvelisib 75 mg PO BID, administered in 28-day cycles.
    Intervention: Drug: Duvelisib
  • Experimental: Expansion Phase
    Duvelisib administered in 28-day cycles (dose determined in Optimization Phase)
    Intervention: Drug: Duvelisib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03372057
Other Study ID Numbers  ICMJE VS-0145-225
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SecuraBio
Study Sponsor  ICMJE SecuraBio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Cohan, MD SecuraBio Chief Medical Officer
PRS Account SecuraBio
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP