Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Emory University
With
PRIMARY OBJECTIVE: I. To assess the increase in CD27+/CD28+ T cells, after 8 to 15 day exposure duvelisib prior to collection of mononuclear cells for chimeric antigen receptor T-cell (CART cell) manufacturing. SECONDARY OBJECTIVES: I. To evaluate patient compliance with duvelisib. II. To evaluate the time required for manufacturing CAR-T using mononuclear cells from duvelisib-treated patients. III. To describe the frequencies of CD27/28 double positive T cells and CD4/8 double negative T cells. IV. To evaluate expansion and persistence of CAR-T cells V. To evaluate overall response rates following CAR-T cell therapy VI.To evaluate survival rates following CAR-T cell therapy VII. To describe the frequency of CRS and neurotoxicity requiring ICU transfer (for CRS or neurotoxicity) and/or treatment VIII. Describe the safety and tolerability profile of duvelisib OUTLINE: Patients receive duvelisib orally (PO) twice daily (BID) for 2 weeks prior to collection of CAR-T cells in the absence of disease progression or unacceptable toxicity. Patients then receive tisagenlecleucel via infusion. Patients are followed up 100 days after CAR-T infusion.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
