Duvelisib for Peripheral T-Cell Lymphoma

(PRIMO Trial)

Recruiting at36 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: SecuraBio

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of phosphoinositide-3-kinase-delta, gamma (PI3K-δ,γ), in participants with relapsed/refractory peripheral T-cell lymphoma (PTCL).

Research Team

David Cohan, MD

Principal Investigator

SecuraBio Chief Medical Officer

Eligibility Criteria

This trial is for adults with relapsed or refractory Peripheral T Cell Lymphoma (PTCL) who have tried at least one treatment without success. They must have a specific type of PTCL confirmed by pathology and measurable disease. People can't join if they've had prior PI3K inhibitor treatments, CNS lymphoma involvement, are on high-dose steroids or immunosuppressants, or have an active systemic infection.

Inclusion Criteria

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

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

Exclusion Criteria

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

Known central nervous system involvement by PTCL

Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor

Treatment Details

Interventions

• Duvelisib (PI3K Inhibitor)

Trial Overview The study tests Duvelisib, an oral medication targeting certain enzymes in cancer cells (PI3K-δ,γ), to see its effectiveness in patients with PTCL that has not responded well to previous treatments. It's a Phase 2 trial conducted across multiple centers where all participants receive the drug.

Participant Groups

Group I: Expansion Phase Experimental Treatment 1 Intervention

Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with complete response (CR), partial response (PR) or stable disease (SD), in 28-day cycles (dose determined in Optimization Phase).

Group II: Dose Optimization Phase: Cohort 2 Experimental Treatment 1 Intervention

Duvelisib 75 mg PO BID, administered in 28-day cycles.

Group III: Dose Optimization Phase: Cohort 1 Experimental Treatment 1 Intervention

Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.

Who Is Running the Clinical Trial?

SecuraBio

Lead Sponsor

Trials

29

Recruited

2,400+