Pembro + Blina Combination in Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemia or Lymphoma
Status:
Withdrawn
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
This study combines the immune checkpoint inhibitor pembrolizumab with the BITE antibody
blinatumomab for the treatment of relapsed/refractory pre-B cell ALL. Pembrolizumab at the
proposed dosing schedule has been very well tolerated in adult studies, including elderly and
unfit patients, as well as in pediatric patients. Both blinatumomab and pembrolizumab are
FDA-approved for use in children as well as adults. Phase I/II trials in adult patients have
demonstrated safety and activity of pembrolizumab in combination with multiple agents. In
this trial, the combination of pembrolizumab and blinatumomab will be investigated for
toxicity as well as possible synergy in the treatment of relapsed/refractory pre-B cell ALL.
This is a single institution investigator-initiated pilot study designed to test the safety
and feasibility of combining pembrolizumab and blinatumomab immunotherapies in children,
adolescents, and young adults with CD19 positive hematologic malignancies. The investigator
will define the toxicity profile of the combination in two safety strata based on whether or
not a patient has had a prior allogeneic hematopoietic stem cell transplant (HSCT), as they
hypothesize that the immune toxicities may differ between strata. In addition, the overall
response rate (CR/CRh) to this therapy will be estimated. Additional biologic correlates will
be conducted to delineate the effect of the combination therapy on the patient's
leukemia/lymphoma and T-cell populations and how this may influence response to therapy.