Duvelisib Maintenance for T-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByAmanda Cashen, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with certain types of T-cell lymphoma eligible for or have had a stem cell transplant can join. They must be generally healthy, not pregnant, and agree to use contraception. Excluded are those with severe lung disease, recent heart issues, drug allergies similar to duvelisib's components, active infections or other cancers needing treatment.

Inclusion Criteria

I have been diagnosed with a type of T cell non-Hodgkin lymphoma.

I am 18 years old or older.

I am eligible for or have had a stem cell transplant using my own cells within the last month.

I can take care of myself and am up and about more than half of my waking hours.

My kidneys, liver, and blood are functioning within the required ranges.

Exclusion Criteria

I cannot receive preventive treatments for certain infections.

I have no active cancer except for certain skin, cervical, bladder, or prostate cancers that don't need treatment.

I do not have active hepatitis B or C.

I have not received a live vaccine within the last 6 weeks.

I am currently being treated for an infection.

I am not currently on, nor have I been on any experimental therapy in the last 4 weeks.

I am currently taking high doses of steroids or other drugs that weaken my immune system.

I have a history of chronic liver disease.

I do not have any serious ongoing illnesses like heart failure or uncontrolled infections.

I have a lung condition that severely affects my breathing.

Participant Groups

The trial is testing if taking the drug duvelisib after a stem cell transplant is safe and helps patients with T-cell lymphomas live longer without their cancer getting worse. Participants will receive regular doses of duvelisib and undergo blood tests to monitor effects.

1Treatment groups

Experimental Treatment

Group I: Duvelisib MaintenanceExperimental Treatment2 Interventions

* 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.