Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas

NCT07293403 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 25403NCI-2025-09029P30CA033572
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Will be estimated by Kaplan-Meier method with a 95% confidence interval.

  At 1 year

Secondary Outcomes (5)

• Rate of duvelisib discontinuation due to toxicity while receiving therapy (tolerability)

  Up to 2 years

• Patient-reported outcomes

  At baseline, day 1 of each cycle and at end of treatment, up to 5 years

• Time to next therapy

  From starting duvelisib to the start of next treatment, up to 5 years

• Progression free survival

  From starting duvelisib maintenance therapy to disease progression or death, whichever occurs earlier, up to 5 years

• Overall survival

  From starting duvelisib to the date of death due to any cause, up to 5 years

Study Arms (1)

Treatment (duvelisib)

EXPERIMENTAL

Patients receive duvelisib PO 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 PET/CT scans and blood sample collection throughout the study. Patients may also undergo bone marrow aspiration and biopsy on study.

Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Duvelisib; Procedure: Positron Emission Tomography; Other: Survey Administration

Interventions

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Treatment (duvelisib)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Treatment (duvelisib)

Duvelisib DRUG

Given PO

Also known as: 8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one, Copiktra, INK-1197, IPI 145, IPI-145, IPI145

Treatment (duvelisib)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Treatment (duvelisib)

Survey Administration OTHER

Ancillary studies

Treatment (duvelisib)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (duvelisib)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow aspiration

Treatment (duvelisib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative.
• Assent, when appropriate, will be obtained per institutional guidelines
• Age: ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) ≤ 2
• Histologically confirmed nodal T-follicular helper (TFH) cell lymphomas or PTCL-not otherwise specified (NOS). Nodal TFH cell lymphomas encompass three subtypes:
• Angioimmunoblastic T-cell lymphoma (AITL)(World Health Organization 4th edition revised \[WHO4R\])/follicular helper T-cell lymphoma (TFH lymphoma), angioimmunoblastic type (International Consensus Classification \[ICC\])/nodal TFH cell lymphoma, angioimmunoblastic-type (World Health Organization 5th edition \[WHO5\])
• Nodal PTCL with TFH phenotype (nodal PTCL, TFH)(WHO4R)/TFH lymphoma, NOS (ICC)/nodal TFH cell lymphoma, NOS (WHO5)
• Follicular T-cell lymphoma (FTCL)(WHO4R)/TFH lymphoma, follicular type (ICC)/ nodal TFH cell lymphoma, follicular-type (WHO5)
• Completion of first-line multi-agent chemotherapy with a cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP)-based regimen and documentation of complete response (CR) per Lugano criteria within the previous 6 months prior to enrollment. Prior corticosteroid monotherapy is not considered a line of therapy
• Ineligible for or decline consolidative autologous stem cell transplantation. Ineligibility is defined by:
• Patient deemed ineligible for high-dose chemotherapy and ASCT based on physician's assessment
• AND at least one of the following criteria:
• Age ≥ 65 years or
• Age ≥ 18 years and Hematopoietic Cell Transplantation-specific Comorbidity Index score ≥ 3
• Recovery to ≤ grade 1 or baseline for any toxicities due to prior treatments, with the exception of peripheral neuropathy (recovery to ≤ grade 2) or alopecia

You may not qualify if:

• Prior organ transplantation
• Major surgery within 4 weeks prior to enrollment
• Administration of a live vaccine within 30 days of cycle (C) 1 day (D) 1
• Unable to receive prophylactic treatment for pneumocystis at enrollment
• Use of medications or consumption of foods that are strong inducers or inhibitors of CYP3A must be discontinued at least 2 weeks prior to study intervention. Patients who (after enrollment) require use of a strong CYP3A4 inhibitor to treat a fungal/mold infection will require dose reductions
• Known central nervous system involvement by PTCL
• Patients with known diagnosis of
• Active cytomegalovirus (CMV) infection (patients with detectable viral load)
• History of tuberculosis treatment within 2 years prior to enrollment
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for infection, but systemic treatment must be completed by cycle 1 day 1
• If a patient has signs/symptoms suggestive of SARS-CoV-2 infection, the patient must have a negative molecular (e.g., polymerase chain reaction \[PCR\]) test or 2 negative antigen test results at least 24 hours apart. Patients who do not meet SARS-CoV-2 infection eligibility criteria must be screen-failed and may only be rescreened if the following have been met:
• At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms
• History of cirrhosis or chronic alcohol abuse
• Symptomatic inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of duvelisib
• Concurrent active malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver: nonmelanoma skin cancer, carcinoma in situ of the cervix

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

Specimen Handling; Biopsy; duvelisib; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Christina Poh

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 19, 2025
• Study Start (Estimated): June 7, 2026
• Primary Completion (Estimated): November 23, 2027
• Study Completion (Estimated): November 23, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)