Follicular Helper T-Cell LymphomaPhase 2NCT07293403
Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas
A Phase 2 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Follicular Helper T-Cell Lymphoma and Peripheral T-Cell Lymphoma, Not Otherwise Specified, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Helper T-Cell Lymphoma, Peripheral T-Cell Lymphoma, Not Otherwise Specified
- What is being tested?
- Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 17 Sep 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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])
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- 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
- Platelets ≥ 25,000/mm^3
- Hemoglobin ≥ 8 g/dL
- CD4 lymphocyte count ≥ 50/mm^3 (0.05 × 10^9/L)
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (in patients with Gilbert's Syndrome a bilirubin > 1.5 × ULN but ≤ 3 × ULN may be allowed with sponsor approval)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) ≤ 2.5 × ULN
- Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × ULN
- Serum creatinine ≤ 2.0 × ULN or creatinine clearance ≥ 30 mL/min (estimated by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] or Cockcroft-Gault equation or measured)
- Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR patients with presence of hepatitis B core antibody (HBcAb), but absence of hepatitis B surface antigen (HBsAg), are eligible if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable (< 20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
- Women of childbearing potential (WOCBP): negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months. Women who are considered not to be of childbearing potential are not required to have a pregnancy test
- Agreement by females and males of reproductive potential (i.e., not surgically sterile or female patients who are not postmenopausal) must be willing to use a highly effective method of contraception for the duration of study treatment and for at least 1 months after the last dose of duvelisib
Who cannot join
- 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
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- 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
- Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, such as pulmonary disease, including obstructive pulmonary disease and history of bronchospasm, uncontrolled diabetes, severe psychiatric disorder or unstable cardiac disease as defined by one of the following:
- Cardiac events such as myocardial infarction (MI), stroke or unstable angina within the past 6 months
- New York Heart Association (NYHA) heart failure class III-IV
- Uncontrolled atrial fibrillation or hypertension
- History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to duvelisib
- Participants who are receiving other investigational agents
- Female patients who are breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Christina Poh, 626-239-5289, cpoh@coh.org
Christina Poh
About this study
Official title: A Phase II Study of Duvelisib Maintenance After First-Line Therapy for Peripheral T-Cell Lymphoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- Determine the tolerability and preliminary survival outcomes of duvelisib maintenance therapy.
EXPLORATORY OBJECTIVE:
- 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.
- Being tested
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Duvelisib
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow biopsy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
DuvelisibDrug
Also called 8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one, Copiktra, INK-1197, IPI 145
Given PO
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET scan
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Duvelisib; Procedure: Positron Emission Tomography; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Will be estimated by Kaplan-Meier method with a 95% confidence interval.
Measured: At 1 year
Secondary outcomes (5)
Rate of duvelisib discontinuation due to toxicity while receiving therapy (tolerability)
Measured: Up to 2 years
Patient-reported outcomes
As measured by the Patient-Reported Outcomes Measurement Information System, Global Health and Functional Assessment of Chronic Illness Therapy-Item GP5 scale.
Measured: At baseline, day 1 of each cycle and at end of treatment, up to 5 years
Time to next therapy
The Kaplan-Meier method will be used to estimate the time to event.
Measured: From starting duvelisib to the start of next treatment, up to 5 years
Progression free survival
The Kaplan-Meier method will be used to estimate the time to event.
Measured: From starting duvelisib maintenance therapy to disease progression or death, whichever occurs earlier, up to 5 years
Overall survival
The Kaplan-Meier method will be used to estimate the time to event.
Measured: From starting duvelisib to the date of death due to any cause, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start3 Aug 2026
- Primary completion17 Sep 2028 (estimated)
- Study completion17 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Helper T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christina Poh, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293403
- Sponsor's protocol ID
- 25403
- Other IDs
- NCI-2025-09029, 25403, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No