Back to resultsA Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
Primary Purpose
Peripheral T-cell Lymphoma
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Duvelisib
Duvelisib
Duvelisib
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring Lymphoma, T-cell Lymphoma, Relapse, Refractory, PI3K-δ,γ
Eligibility Criteria
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 (PTCL-NOS);
- Angioimmunoblastic T-cell lymphomas (AITL);
- Anaplastic large cell lymphoma (ALCL); or
- Natural-killer/T-cell lymphoma (NKTL)
Received at least 2 cycles of one prior regimen administered with curative intent and one of the following:
- failed to achieve at least a partial response after 2 or more cycles;
- failed to achieve a complete response after 6 or more cycles; and/or
- progressed after an initial response
- For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
- 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:
- Clinical evidence of transformation to a more aggressive subtype of lymphoma
- Received prior treatment with a phosphoinositide-3-kinase (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 (QD)
- Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening
Sites / Locations
- City of Hope National Medical Center
- University of California - Irvine
- University of California - Los Angeles
- Emory University Winship Cancer Institute
- Northwestern University - Feinberg School of Medicine
- Norton Cancer Institute
- University of Maryland
- Dana Farber Cancer Institute
- Washington University
- Memorial Sloan Kettering Cancer Center
- University of Rochester
- Stony Brook Cancer Center
- Levine Cancer Institute
- Novant Health
- Duke University
- The Ohio State Univeristy
- Toledo Cancer Center
- UPMC Hillman Cancer Center
- Baylor Research Institute - Charles Sammons Cancer Center
- Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV
- Universitätsklinikum Carl Gustav Carus
- ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo
- A.O.di Bologna Policl.S.Orsola
- Ieo, Irccs
- Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore
- Azienda Ospedaliera Santa Maria di Terni
- Christie Hospital NHS Foundation Trust
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dose Optimization Phase: Cohort 1
Dose Optimization Phase: Cohort 2
Expansion Phase
Arm Description
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.
Duvelisib 75 mg PO BID, administered in 28-day cycles.
Duvelisib administered in 28-day cycles (dose determined in Optimization Phase)
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
Best response of CR or PR
Secondary Outcome Measures
Overall response rate (ORR)
Number of participants with Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0
Duration of Response (DOR)
Progression-free survival (PFS)
Disease control rate (DCR)
Overall survival (OS)
Percentage of patients who receive the optimal dose of duvelisib
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03372057
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SecuraBio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma
Keywords
Lymphoma, T-cell Lymphoma, Relapse, Refractory, PI3K-δ,γ
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Optimization Phase: Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose Optimization Phase: Cohort 2
Arm Type
Experimental
Arm Description
Duvelisib 75 mg PO BID, administered in 28-day cycles.
Arm Title
Expansion Phase
Arm Type
Experimental
Arm Description
Duvelisib administered in 28-day cycles (dose determined in Optimization Phase)
Intervention Type
Drug
Intervention Name(s)
Duvelisib
Intervention Description
Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
Intervention Type
Drug
Intervention Name(s)
Duvelisib
Intervention Description
Duvelisib PO 75 mg BID in 28-day cycles.
Intervention Type
Drug
Intervention Name(s)
Duvelisib
Intervention Description
Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase)
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Best response of CR or PR
Time Frame
From start of treatment to first documented response, assessed up to 2 cycles (58 days)
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Time Frame
From start of treatment until disease progression or unacceptable toxicity, assessed up to 2 cycles (58 days)
Title
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
Title
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
Title
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
Title
Disease control rate (DCR)
Time Frame
Greater than or equal to 8 weeks
Title
Overall survival (OS)
Time Frame
From start of treatment until death, 6 months
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 (PTCL-NOS);
Angioimmunoblastic T-cell lymphomas (AITL);
Anaplastic large cell lymphoma (ALCL); or
Natural-killer/T-cell lymphoma (NKTL)
Received at least 2 cycles of one prior regimen administered with curative intent and one of the following:
failed to achieve at least a partial response after 2 or more cycles;
failed to achieve a complete response after 6 or more cycles; and/or
progressed after an initial response
For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
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:
Clinical evidence of transformation to a more aggressive subtype of lymphoma
Received prior treatment with a phosphoinositide-3-kinase (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 (QD)
Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California - Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
University of California - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University - Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Facility Name
Stony Brook Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Novant Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Ohio State Univeristy
City
Columbia
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
Toledo Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Baylor Research Institute - Charles Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
A.O.di Bologna Policl.S.Orsola
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ieo, Irccs
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria di Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
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