A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)
Categories (click each to see list of all clinical trials associated with that category): Child Health Research Institute (CHRIONC), Pediatric (PEDONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Hillary Stevenson
+1 402-836-9305
hillary.stevenson@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04315324?intr=NCT04315324&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVE:
I. To assess the response rate (complete remission [CR] or CR with incomplete count recovery [CRi]) of AKR1C3-activated prodrug OBI-3424 (OBI-3424) in patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL).
SECONDARY OBJECTIVES:
I. To estimate the frequency and severity of toxicities of OBI-3424 in this patient population.
II. To estimate event-free survival (EFS), relapse-free survival (RFS) and overall survival (OS) in this patient population.