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).
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
Drug | Synonyms | Arms |
---|
Duvelisib | | Dose Optimization Phase: Cohort 1 |
Duvelisib | | Dose Optimization Phase: Cohort 2 |
Duvelisib | | Expansion 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
Name | Type | Description | Interventions |
---|
Dose Optimization Phase: Cohort 1 | Experimental | 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. | |
Dose Optimization Phase: Cohort 2 | Experimental | Duvelisib 75 mg PO BID, administered in 28-day cycles. | |
Expansion Phase | Experimental | Duvelisib administered in 28-day cycles (dose determined in Optimization Phase) | |
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: | Active, not recruiting |
Lead Sponsor: | SecuraBio |
Trial Keywords
- Lymphoma
- T-cell Lymphoma
- Relapse
- Refractory
- PI3K-δ,γ
Last Updated
May 18, 2021