T-Cell Lymphoma
Conditions
Brief 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.
Interventions
DRUGDuvelisib
SecuraBio will supply duvelisib
PROCEDUREPeripheral blood draw
-Prior to transplant, cycle 1 day 1 of duvelisib, and at the time of all imaging studies
Sponsors
Washington University School of Medicine
SecuraBio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerabilty as measured by number of study treatment related adverse events | From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months) | -Adverse events will be assessed using CTCAE v5.0 criteria |
| Safety and tolerabilty as measured by discontinuations due to treatment-related adverse events | From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months) | — |
| Overall response rate (ORR) | 100 days after transplant | -Defined as the percentage of patients with a confirmed complete or partial response, monitored with PET/CT scans. |
| Overall survival (OS) | 2 years | -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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmanda Cashen, M.D.
Washington University School of Medicine
Outcome results
None listed