Print this page

A Phase 2 Study of Blinatumomab in Combination with Nivolumab, a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged < 1 to < 31 Years Old with First Relapse.

- To compare rate of minimal residual disease (MRD) negative second remission after up to two cycles of Reinduction with blinatumomab vs. blinatumomab/nivolumab in Group 1 patients aged; 1 to < 31 years old with first relapse of CD19+ B-ALL.

- To compare EFSPI (EFS post-Induction) between Consolidation with blinatumomab vs. blinatumomab/nivolumab in Group 3 patients aged; 1 to <31 years old with first relapse of CD19+ B-ALL.

- To evaluate the safety and tolerability of blinatumomab/nivolumab in patients aged 1 to < 31 years old with first relapse of CD19+ B ALL.

- To compare EFSPI between blinatumomab vs. blinatumomab/nivolumab in Group 2 patients aged; 1 to < 31 years old with first relapse of CD19+ B-ALL. In Group 1 patients, compare EFS between blinatumomab monotherapy and blinatumomab/nivolumab arms as compared to similar patients treated on the predecessor trial AALL1331.

In Group 1 patients: compare toxicity as defined by Grade 3 or greater adverse events during the first cycle of blinatumomab or blinatumomab/nivolumab to similar patients treated with Block 1 of cytotoxic chemotherapy on the predecessor trial AALL1331.

In Group 2 patients with MRD; 0.1% after VXLD, compare MRD negative second remission (Rem-2) rate after the first cycle of immunotherapy between blinatumomab monotherapy and blinatumomab/nivolumab arms.
In patients with Down syndrome (DS) with first relapse of B-ALL, describe the safety, tolerability and efficacy (as defined by MRD negative second remission, Rem-2) after up to two cycles of blinatumomab/nivolumab.

Protocol Number: 112011
Phase: Phase II
Applicable Disease Sites: Any Site
Drugs Involved: Blinatumomab (AMG103)
Opdivo (Nivolumab)
Principal Investigator: Richard Drachtman M.D.
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
  • RWJBarnabas Health
    • Newark Beth Israel Medical Center
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.