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
City of Hope Medical Center
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD)/Recommended Phase 2 dose (RP2D) of brentuximab vedotin in combination with lenalidomide in patients with relapsed/ refractory cutaneous T-cell lymphoma (CTCL). II. Assess safety and tolerability of brentuximab vedotin in combination with lenalidomide in patients with relapsed/ refractory CTCL. SECONDARY OBJECTIVES: I. Estimate the rate of objective global response that lasts at least 4 months (ORR4) , complete response (CR) rate, progression-free survival (PFS) of brentuximab vedotin in combination with lenalidomide in patients with relapsed/ refractory CTCL. II. Estimate the rate and duration of clinically meaningful reduction in pruritus (CMRP). III. Correlate response to baseline CD30 levels in tissue samples. TERTIARY OBJECTIVES: I. Estimate the response endpoints incorporating Lugano response criteria for patients with PET+ disease. II. Explore temporal gene expression profile in skin/ blood samples that may predict response to combination therapy. OUTLINE: This is a dose-escalation study of lenalidomide. Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1 and lenalidomide orally (PO) once daily (QD) on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then up to 12 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
