T-Cell LymphomaPhase 2NCT04331119
Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas
A Phase 2 study testing Duvelisib and Peripheral blood draw in people with T-Cell Lymphoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators hypothesize that duvelisib maintenance after autologous stem cell transplant in patients with T-cell lymphomas will be safe and well tolerated, and will improve progression free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-Cell Lymphoma
- What is being tested?
- Duvelisib and Peripheral blood draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2020to 22 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase II Trial With Safety Lead in of Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas
The investigators hypothesize that duvelisib maintenance after autologous stem cell transplant in patients with T-cell lymphomas will be safe and well tolerated, and will improve progression free survival.
- Conditions
- T-Cell Lymphoma
- Being tested
- Duvelisib, Peripheral blood draw
- 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.
DuvelisibDrug
Also called Copiktra
SecuraBio will supply duvelisib
Peripheral blood drawProcedure or surgery
-Prior to transplant, cycle 1 day 1 of duvelisib, and at the time of all imaging studies
| Study group | Role | What they receive |
|---|---|---|
| Duvelisib Maintenance | Experimental | * Duvelisib maintenance at 25 mg PO BID after count recovery (approximately 30 days after transplant) for one year. If the patient is in a complete remission at day +100, with no evidence of disease on PET/CT, then the dosing schedule of duvelisib may be changed to 25 mg BID for 14 days, then 14 days off in 28 day cycles (at the treating physician's discretion). If the patient has residual disease, duvelisib will continue at 25 mg BID until they have a negative PET CT. PET CTs will be completed every 3 months for patients with residual disease. Duvelisib maintenance will be continued for one year post-transplant.
* Starting on 06/10/2021, all new participants will be enrolled to take 25 mg BID of duvelisib on days 1-14 of a 28 day cycle. Receives: Drug: Duvelisib; Procedure: Peripheral blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The PFS time will be calculated as the duration of time from autologous stem cell transplant (day 0) to the date of earliest progression or death, whichever occurs first.
Measured: 2 years
Secondary outcomes (4)
Safety and tolerabilty as measured by number of study treatment related adverse events
-Adverse events will be assessed using CTCAE v5.0 criteria
Measured: From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months)
Safety and tolerabilty as measured by discontinuations due to treatment-related adverse events
Measured: From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months)
Overall response rate (ORR)
-Defined as the percentage of patients with a confirmed complete or partial response, monitored with PET/CT scans.
Measured: 100 days after transplant
Overall survival (OS)
-Defined as the duration of time from the date of first dose of study treatment to death from any cause. Patients who are alive by the data cutoff date will be censored at the last follow up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start23 Jul 2020
- Primary completion22 Apr 2026
- Study completion22 Apr 2026
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- SecuraBio
- Responsible party
- Sponsor
- Investigators
- Amanda Cashen, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331119
- Sponsor's protocol ID
- 202005165
- Status last verified
- May 2026
- First submitted
- 30 Mar 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial With Safety Lead in of Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT04331119
- Acronym / sponsor ID
- 202005165
- Conditions
- T-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- SecuraBio
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that duvelisib maintenance after autologous stem cell transplant in patients with T-cell lymphomas will be safe and well tolerated, and will improve progression free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duvelisib Maintenance | Experimental | Drug: Duvelisib, Procedure: Peripheral blood draw* Duvelisib maintenance at 25 mg PO BID after count recovery (approximately 30 days after transplant) for one year. If the patient is in a complete remission at day +100, with no evidence of disease on PET/CT, then the dosing schedule of duvelisib may be changed to 25 mg BID for 14 days, then 14 days off in 28 day cycles (at the treating physician's discretion). If the patient has residual disease, duvelisib will continue at 25 mg BID until they have a negative PET CT. PET CTs will be completed every 3 months for patients with residual disease. Duvelisib maintenance will be continued for one year post-transplant. * Starting on 06/10/2021, all new participants will be enrolled to take 25 mg BID of duvelisib on days 1-14 of a 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuvelisibAlso: CopiktraSecuraBio will supply duvelisib | Drug | Duvelisib Maintenance |
| Peripheral blood draw-Prior to transplant, cycle 1 day 1 of duvelisib, and at the time of all imaging studies | Procedure or surgery | Duvelisib Maintenance |
Primary outcome
Progression-free survival (PFS)
Time frame: 2 years
The PFS time will be calculated as the duration of time from autologous stem cell transplant (day 0) to the date of earliest progression or death, whichever occurs first.
4 secondary outcomes
Safety and tolerabilty as measured by number of study treatment related adverse events
Time frame: From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months)
Safety and tolerabilty as measured by discontinuations due to treatment-related adverse events
Time frame: From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months)
Overall response rate (ORR)
Time frame: 100 days after transplant
Overall survival (OS)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for T-Cell Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Cashen, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duvelisib and Peripheral blood draw in people with T-Cell Lymphoma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Loss of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.