A Phase III Study of Blinatumomab in Combination with Chemotherapy in Patients with Newly Diagnosed Standard-Risk or Down Syndrome B-Lymphoblastic Leukemia and Patients with Localized B-Lymphoblastic Lymphoma

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Full Title

A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy) AALL1731 (CIRB)

Purpose

Doctors are seeking new ways to minimize the size effects of chemotherapy in patients with B-cell acute lymphoblastic leukemia (B-ALL). In this study, researchers are assessing the use of the drug blinatumomab in place of some of the chemotherapy drugs used to treat patients with Down syndrome and high-risk B-ALL and in patients with standard-risk B-ALL. They are also evaluating less intensive chemotherapy regimens for patients with standard-risk B-ALL, localized B-ALL, and B-lymphoblastic lymphoma (B-LLy).

There are multiple parts in this study; researchers will assess patients’ response to initial “induction” chemotherapy to determine which treatment they will receive. Blinatumomab may induce changes in the body’s immune system and interfere with the ability of cancer cells to grow and spread. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is for patients who have Down syndrome with B-ALL or B-LLy and patients with localized B-LLy.
  • Patients may not have received any prior anticancer treatment.
  • Patients without Down syndrome must be at least 1 year of age and under age 10. Those with Down syndrome and patients with localized B-ALL must be age 1-31 years.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

19-481

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators