This study focuses on individuals who have been diagnosed with either standard risk B-cell lymphoblastic leukemia (B-ALL) or B-cell lymphoblastic leukemia and who have Down syndrome (DS B-ALL) of any risk level. B-ALL is a cancer of the white blood cells. The term risk refers to the chance of the cancer coming back after treatment. The purpose of Part I of this study is to collect information on the leukemia and how it responds to the first phase of treatment (called “induction”). Researchers will collect blood and bone marrow tests to evaluate how quickly the leukemia is responding to treatment, in addition to determining the risk group of the patient’s leukemia. Patients may be offered the chance to take part in Part II of the study after induction once their risk group is known. Participants may then be randomly assigned to receive an investigational medicine called blinatumomab plus standard treatment. All patients will be treated with the same length of therapy in Part II of the study, regardless of gender. (The standard duration of treatment in ALL trials has been gender-based, with boys receiving an additional year of treatment. However, recent analyses have shown that the additional year of therapy for boys may not lead to improvements in their outcome.) Researchers hope that eliminating the additional year of therapy for boys on this study will result in fewer long term side effects.
What is the full name of this clinical trial?
AALL1731: A Phase 3 Trial Investigating Blinatumomab in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma ^