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

The standard treatment for B-cell acute lymphoblastic leukemia (B-ALL) is chemotherapy, but it has side effects. Doctors are seeking new ways to minimize the size effects of treatment, either by using new drugs or reducing the intensity of treatment without decreasing its effectiveness.

In this study, researchers are assessing the use of the drug blinatumomab in place of some of the chemotherapy drugs 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 is already used to treat pediatric leukemia. It works by enabling white blood cells called T cells to recognize and kill cancerous B cells. 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 and to inquire about eligibility for this study, please contact Dr. Kavitha Ramaswamy at 212-639-8451.

Protocol

19-481

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators