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

Peripheral T-cell Lymphoma Clinical Trial

— PRIMO  

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 Details — Status: Completed

Administrative data

• NCT number: NCT03372057
• Other study ID #: VS-0145-225
• Secondary ID: 2019-001123-13
• Status: Completed
• Phase: Phase 2
• Start date: February 22, 2018
• Est. completion date: December 22, 2023

Study information

• Verified date: January 2024
• Source: SecuraBio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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/refractory Peripheral T-cell Lymphoma (PTCL).

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 100-130 patients may be enrolled and will receive Duvelisib dose in 28-day cycles as determined in Dose Optimization Phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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 patients 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 cm in at least one dimension by conventional techniques (18FDG-PET-CT, CT with contrast, MRI)

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 phosphoinositide-3-kinase (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 (QD)

6. Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening

7. Known hypersensitivity to duvelisib and/or its excipients

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

Drug:
• Duvelisib
Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
• Duvelisib
Duvelisib PO 75 mg BID in 28-day cycles.
• Duvelisib
Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase)

Locations

Country	Name	City	State
Germany	Universitätsklinikum Carl Gustav Carus	Dresden	Sachsen
Germany	Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV	Halle	Sachsen-Anhalt
Italy	ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo	Bergamo
Italy	A.O.di Bologna Policl.S.Orsola	Bologna
Italy	Ieo, Irccs	Milano
Italy	Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore	Roma
Italy	Azienda Ospedaliera Santa Maria di Terni	Terni
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Novant Health	Charlotte	North Carolina
United States	Northwestern University - Feinberg School of Medicine	Chicago	Illinois
United States	The Ohio State University	Columbia	Ohio
United States	Baylor Research Institute - Charles Sammons Cancer Center	Dallas	Texas
United States	City of Hope National Medical Center	Duarte	California
United States	Duke University	Durham	North Carolina
United States	University of California - Irvine	Irvine	California
United States	University of California - Los Angeles	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	Washington University	Saint Louis	Missouri
United States	Stony Brook Cancer Center	Stony Brook	New York
United States	Toledo Cancer Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
SecuraBio

Countries where clinical trial is conducted

United States,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	Best response of CR or PR	From start of treatment to first documented response, assessed up to 2 cycles (58 days)
Secondary	Number of Participants with Treatment-emergent Adverse events (TEAEs) as Assessed by CTCAE v4.0		From start of treatment to end of treatment plus 30 days; 7 months
Secondary	Duration of Response (DOR)		Time from the first documentation of response to first documentation of progressive disease or death due to any cause, 6 months
Secondary	Progression-free Survival (PFS)		Time from start of treatment to first documentation of progression or date of death from any cause, whichever came first, 4 months
Secondary	Disease Control Rate (DCR)		Greater than or equal to 8 weeks
Secondary	Overall Survival (OS)		From start of treatment until death, 6 months
Secondary	Plasma Concentration of Duvelisib and Metabolites		Days 1, 8, and 15 (Predose, up to 6 hours post dose) of Cycles 1, 2, 3, and 5 (each cycle is 28 days)