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

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ClinicalTrials.gov Identifier: NCT03372057
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

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).

Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphoma Drug: Duvelisib Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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.
Drug: Duvelisib
Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.

Experimental: Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID, administered in 28-day cycles.
Drug: Duvelisib
Duvelisib PO 75 mg BID in 28-day cycles.

Experimental: Expansion Phase
Duvelisib administered in 28-day cycles (dose determined in Optimization Phase)
Drug: Duvelisib
Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: From start of treatment until disease progression or unacceptable toxicity, assessed up to 2 cycles (58 days) ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Disease control rate (DCR) [ Time Frame: Greater than or equal to 8 weeks ]
  6. Overall survival (OS) [ Time Frame: From start of treatment until death, 6 months ]
  7. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372057


Contacts
Contact: Jasminder Soto 781-292-4250 jsoto@verastem.com
Contact: Deborah Lloyd 781-292-4230 dlloyd@verastem.com

Locations
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Rosemarie Abary    626-218-8087    rabary@coh.org   
Principal Investigator: Jasmine Zain, MD         
United States, Illinois
Northwestern University - Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Nick Cornicelli    312-695-0706    nicholas.cornicelli@northwestern.edu   
Principal Investigator: Barbara Pro, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Erin Jeter    617-632-6218    Erin_Jeter@DFCI.HARVARD.EDU   
Principal Investigator: Eric Jacobsen, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kristen McDaniels, BS    314-747-1207    k.mcdaniels@wustl.edu   
Principal Investigator: Neha Mehta-Shah, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Nasrin Ahmed    646-449-1311    ahmedn1@mskcc.org   
Principal Investigator: Steven Horwitz, MD         
University of Rochester Recruiting
Rochester, New York, United States, 14627
Contact: Yelena Lerman    585-276-8333    ylerman@urmc.rochester.edu   
Contact: Erin Cebula       erin_cebula@urmc.rochester.edu   
Principal Investigator: Carla Casulo, MD         
United States, Ohio
The Ohio State Univeristy Recruiting
Columbia, Ohio, United States, 43202
Contact: Pamela Heeter    614-293-9627    pam.heeter@osumc.edu   
Principal Investigator: Jonathan Brammer, MD         
Sponsors and Collaborators
Verastem, Inc.
Investigators
Study Chair: Hagop Youssoufian, MD Verastem, Inc.

Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT03372057     History of Changes
Other Study ID Numbers: VS-0145-225
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Verastem, Inc.:
Lymphoma
T-cell Lymphoma
Relapse
Refractory
PI3K-δ,γ

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin