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Lymphoma drug duvelisib tested after transplant – trial ends early

NCT ID NCT04331119

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested the drug duvelisib (Copiktra) as a maintenance therapy after an autologous stem cell transplant in 17 people with T-cell lymphoma. The goal was to see if it could safely delay the cancer from coming back. The study was terminated early, so the full results are not available, but the approach aimed to improve progression-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Duvelisib (Copiktra)
What this could lead to
If successful, this could point toward a way to keep T-cell lymphoma from returning after a stem cell transplant.
What could go wrong
This was a small, early-phase trial that was terminated, so results are limited. Duvelisib can cause serious side effects like infections and liver problems.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

17 people

The number who actually took part.

Started

Jul 2020

Finished

Apr 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of T cell non-Hodgkin lymphoma, T cell lymphomas included are peripheral T cell lymphoma not otherwise specified, angioimmunoblastic T cell lymphoma, and systemic anaplastic large cell lymphoma. * Eligible for autologous stem cell transplantation as determined by the treating physician or completed autologous transplant within the last 30 days. * At least 18 years of age at time of enrollment * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Adequate organ function as defined below: * Serum creatinine ≤ 1.5 times institutional upper limit of normal (IULN) * Total bilirubin ≤ 1.5 x IULN. Patients with Gilbert's Syndrome may have a bilirubin \> 1.5 x IULN * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count ≥ 1.0 x 109/L * Platelet count ≥ 75 x 109/L * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN * Women of childbearing potential and men must agree to use highly effective contraception prior to study entry and for the duration of study participation and for 3 months after the last dose of duvelisib. Negative serum β human chorionic gonadotropin (βHCG) pregnancy test within 7 days before first treatment is required if the patient is a woman of childbearing potential. * Participants or a participant's legally authorized representative must be able to understand and willing to sign an IRB approved written informed consent document Exclusion Criteria: * Currently receiving any other experimental therapy or has received experimental therapy within 4 weeks prior to study treatment * History of allergic reaction attributed to compounds of similar chemical or biologic composition to duvelisib or other agents used in the study. * Prior history of drug-induced colitis or drug-induced pneumonitis * History of concurrent interstitial lung disease or severely impaired lung function * History of chronic liver disease or veno-occlusive disease * History of tuberculosis within 2 years prior to enrollment * Administration of a live or live attenuated vaccine within 6 weeks of first duvelisib dose * Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids \> 20 mg of prednisone (or equivalent) per day * Ongoing treatment for systemic bacterial, fungal, or viral infections at screening. Note: patients on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded is all other inclusion/exclusion criteria are met * Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening * Infection with HBV, HCV. Subjects with a positive HBsAg or HCV Ab on pre-transplant infection screening will be excluded. Subjects with a positive HBcAb must have negative HBV DNA to be eligible and must be periodically monitored for HBV reactivation by institutional guidelines. * Baseline QTcF \> 500 milliseconds. This does not apply to subjects with right or left bundle branch blocks * Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment. * Clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea,vomiting, or any other condition that will interfere significantly with drug absorption * Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention. * Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (i.e., subjects with detectable viral load) * History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or unstable cardiac arrhythmia. * Pregnant or breastfeeding. * Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) are contraindicated).

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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.

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.