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Protocol No.AALL1331Principal InvestigatorYork, Teresa
PhasePhase III
Age GroupBoth
TitleAALL1331: Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND# 117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
DescriptionThis randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer growth by finding cancer cells and helping to kill them or carrying cancer-killing substances to them. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.
TreatmentAll patients receive Block 1 over 4 weeks. High Risk and Intermediate Risk patients are randomized to 1 of 2 treatment arms: ARM A: Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT. ARM B: Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT. Low Risk patients are randomized to 1 of 2 treatment arms: ARM C: Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance. ARM D: Patients receive Block 2 over 4 weeks, Blinatumomab Block 2 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Block 3 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Block 3 over 5 weeks, and then Maintenance.
Key EligibilityInclusion Criteria:
-Age 1 year to 30 years
-First relapse of B-ALL with or without extramedullary disease
-No waiting period for patients who relapse while receiving standard maintenance therapy
-Patients who relapse on frontline therapy in phases other than maintenance must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
-Cytotoxic therapy: at least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy, or maintenance chemotherapy
-Biologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
-Stem cell transplant or rescue: patients has not had a prior stem cell transplant or rescue
-Patient has not had prior treatment with blinatumomab
-Patient has not received prior relapse-directed therapy (i.e., this protocol is intended as INITIAL treatment of first relapse)
-Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

For exclusion criteria, please call study site contact(s) for more information.
Applicable Disease SitesLymphoid Leukemia
Therapies InvolvedChemotherapy (NOS)
Immunotherapy
Drugs Involved6-mercaptopurine
Blinatumomab
Calcium Leucovorin
Cytarabine (Cytosine Arabinoside)
Dexamethasone
Hydrocortisone
L-Asparaginase
Methotrexate
Mitoxantrone
Peg-asparaginase
Thioguanine
VP-16 (etoposide)
Vincristine
cyclophosphamide
etoposide
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02101853
ContactGreenebaum Cancer Center Natalie McNally, MS, CCRP Phone:410-328-2808
Pager:410-328-2337 #7041
Email:nmcnally@umm.edu
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