NCT07293403

Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas

A Phase II Study of Duvelisib Maintenance After First-Line Therapy for Peripheral T-Cell Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests how well duvelisib works as treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy (maintenance) for patients with peripheral T-cell lymphomas. Duvelisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells.

Detailed description

PRIMARY OBJECTIVE: I. Determine the efficacy of duvelisib maintenance therapy in peripheral T-cell lymphoma (PTCL) patients who have achieved a complete response (CR) following first-line treatment and are either ineligible for or decline consolidative autologous stem cell transplantation (ASCT). SECONDARY OBJECTIVE: I. Determine the tolerability and preliminary survival outcomes of duvelisib maintenance therapy. EXPLORATORY OBJECTIVE: I. Examine the association between biomarkers (e.g., minimal residual disease \[MRD\]) and clinical outcomes (overall response rate \[ORR\], progression free survival \[PFS\]). OUTLINE: Patients receive duvelisib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients who remain in continuous complete response may continue to receive duvelisib for an additional 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and biopsy during screening, as well as positron emission tomography (PET)/computed tomography (CT) scans and blood sample collection throughout the study. Patients may also undergo bone marrow aspiration and biopsy on study. After completion of study treatment, patients are followed up at 4-6 weeks, then periodically for up to 5 years.

Conditions

• Follicular Helper T-Cell Lymphoma
• Peripheral T-Cell Lymphoma, Not Otherwise Specified

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow biopsy
PROCEDURE	Computed Tomography	Undergo CT scan
DRUG	Duvelisib	Given PO
PROCEDURE	Positron Emission Tomography	Undergo PET scan
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2026-06-07
• Primary completion: 2027-11-23
• Completion: 2027-11-23
• First posted: 2025-12-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study