AALL1821: Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC # 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged ≥ 1 to < 31 Years Old with First Relapse
AALL1821
What is the goal of the study?
This is a phase 2 study for 1st relapse B-ALL. The large goal is to try to induce remission in the highest risk group of patients with immunotherapy and is randomizing patients to blina v blina+nivo based on pre-clinical and early clinical studies showing enhanced blina activity when administered in conjunction with checkpoint blockade. Recent results have shown a highly toxic chemotherapy backbone with toxic death rate of 5% and grade 4 infections of 40%. In addition, for high risk relapse, many patients were still MRD positive at the end of reinduction. Group 1 patients are those who require a HCT and include anyone 18 years or older as well as those who are less than 18 y/o but have recurred <24 months from initial diagnosis. they would receive blina v blina nivo then off protocol hct. group 2 patients are those who have recurred between 24-36 months from diagnosis those who are>36 months but have MRD+ and the end of VXLD and any early IEM (<18 months from diagnosis. these will get vxld re-induction then randomized to blina or blina nivo x 2 cycles then off protocol hct. group 3 includes late relapse>36 months for marrow and >18 months for IEM) who are MRD negative after VXLD, they will be randomized to receive consolidation chemotherapy with blina or blina/nivo. Down’s patients with first relapse will be treated on a single arm pilot study of two cycles of blina+nivo. (Based on results of 1331 – enrollment into both group 2 and 3 is currently closed while consideration for changes to the backbone is undertaken). Objective are to compare the rates of MRD negative CR2 in group 1 patient groups and to compare the EFS post induction for group 3 patients. Secondary aims are to look at EFS in group 2 patients and tool at safety and tolerability of blina/nivo.
Who can participate in the study?
Please contact the study team listed below to learn more.