Finding studies
Finding studies
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Lead
City of Hope Medical Center
With
PRIMARY OBJECTIVE: I. Evaluate the safety and tolerability of the combination of brentuximab vedotin (BV) plus MDR1 inhibitors cyclosporine (CsA)/verapamil hydrochloride (verapamil \[VRP\]). SECONDARY OBJECTIVES: I. Obtain estimates of overall response rate (ORR), complete response (CR) rate, and response duration in patients treated with the combination of BV plus CsA/VRP. II. Estimate overall and progression-free survival in patients treated with the combination of BV plus CsA/VRP. III. Characterize pharmacokinetics of plasma monomethyl auristatin E (MMAE) in cycle 1 (for expansion cohort only). OUTLINE: This is a dose-escalation study of brentuximab vedotin and cyclosporine. Patients receive cyclosporine orally (PO) twice daily (BID) on days 1-5, verapamil hydrochloride PO four times daily (QID) on days 1-5, and brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients who have not progressed are followed up every 6 months until disease progression, start of a new lymphoma therapy, 2 years post treatment, or study completion, whichever is earlier. Patients who progress are followed up periodically.
Age
15–any
Sex
ALL
Healthy volunteers
Not accepted
