A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults

The poor prognosis of older adults with B ALL and their inability to tolerate intensive chemotherapy suitable for children and younger adults necessitates the incorporation of novel agents into the therapeutic regimens of these patients. The encouraging results of therapy with blinatumomab in converting patients who are MRD positive to MRD negative status and the acceptable toxicity profile seen with this bi-specific antibody suggest that it has the potential to improve survival and quality of life of older adults with B ALL. It will also be an important proof of biologic principle that BiTE therapy has the potential to improve outcomes in this challenging patient population. This trial will utilize the chemotherapy program from the UKALLXII/E2993 trial with dosing modifications based on the improved outcomes that are emerging from the completed C10403 AYA trial. Data from the GMALL group suggests that pegaspargase is less well-tolerated in older adults and therefore, will be omitted in patients over age 55 in induction (personal communication, N.Goekbuget)46. These patients also tolerate high-dose corticosteroid doses less well than younger adults and will, therefore, receive shorter courses of corticosteroids in the protocol.
Phase III
Cancer, All Other
Alison Conlin, M.D.
ECOG (Eastern Cooperative Oncology Group)
Laurie Delanty

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