AALL1331 Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND# 117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
Johns Hopkins Kimmel Cancer Center in Baltimore
AALL1331 is a randomized Phase III study to test whether incorporation of blinatumomab into the treatment of patients with childhood B-Lymphoblastic Leukemia (B-ALL) at first relapse will improve disease free survival. Blinatumomab is being tested in this population based on its demonstrated safety profile and single agent activity (induction of MRD-negative remissions in children with multiple relapsed refractory B-ALL). AALL1331 risk stratification is determined based on site of relapse, time to relapse and minimal residual disease (MRD) status following a uniform first block of chemotherapy.
First relapse of B-ALL with or without disease outside of the bone marrow; Patients equal to 1 year and less than 31 years of age at the time of relapse;Patients must not have had a prior stem cell transplant or rescue;Must have adequate organ function;Ph+ ALL, T-ALL or mature B-cell leukemia are not eligible;Patients with known optic nerve and/or retinal involvement are not eligible.
High risk (HR) and intermediate risk (IR) patients will be eligible for randomization to either a control arm with two additional blocks of chemotherapy, or an experimental arm with two blocks of blinatumomab. Both arms will proceed to protocol-specified hematopoietic stem cell transplant (HSCT) that includes a rapid taper of immune suppression for patients with residual disease and no graft vs. host disease (GVHD). Low risk (LR) patients will be eligible for randomization to either a control arm with two blocks of chemotherapy followed by continuation and maintenance chemotherapy, or an experimental arm with one block of chemotherapy, 2 blocks of blinatumomab, each followed by continuation and a third additional block of blinatumomab followed by maintenance.
03/05/2019 05:03 AM