Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas (NCT04331119) | Clinical Trial Compass
TerminatedPhase 2
Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas
Stopped: Loss of funding
United States17 participantsStarted 2020-07-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 experimen…