A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

This study seeks adult subjects with Relapsed/Refractory (R/R) B-precursor ALL. This is a phase 3 randomized, open label study designed to evaluate the efficacy of blinatumomab versus investigator choice of SOC chemotherapy. Adult subjects with R/R B-precursor ALL will be randomized in a 2:1 ratio to receive blinatumomab or treatment with investigator choice of 1 of 4 protocol defined SOC chemotherapy regimens. Primary Endpoint is Overall Survival.

Who is eligible to participate?

Subjects with Philadelphia negative B-precursor ALL, with any of the following: - refractory to primary induction therapy or refractory to salvage therapy, - in untreated first relapse with first remission duration <12 months - in untreated second or greater relapse - or relapse at any time after allogeneic HSCT - Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy. - Greater than 5% blasts in the bone marrow - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Age ≥ 18 years at the time of informed consent - Subject has provided informed consent or subject's legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.

Last updated:

7/30/2014

NCT ID:

NCT02013167

IRB Number:

13-007120