New drug may keep rare lymphoma at bay after first treatment
NCT ID NCT07293403
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This phase II trial is testing whether the drug duvelisib can help prevent peripheral T-cell lymphoma from coming back after initial therapy. About 25 adults with certain types of T-cell lymphoma will take duvelisib as maintenance treatment. The study will track how long patients stay cancer-free and how well they tolerate the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- duvelisib (a kinase inhibitor)
- What this could lead to
- If successful, this could provide a way to keep peripheral T-cell lymphoma from coming back after initial treatment, potentially extending remission.
- What could go wrong
- This is a small, early-phase (phase II) trial with only 25 participants, so results may not apply broadly. Duvelisib can cause side effects like infections or liver issues, and some patients may need to stop treatment due to toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
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