A Phase III Study of Blinatumomab for Newly Diagnosed BCR/ABL-Negative B-Cell Acute Lymphoblastic Leukemia

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A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults (E1910) (CIRB)

Purpose

The standard sequence of treatments for acute lymphoblastic leukemia (ALL) includes induction therapy (intensive initial chemotherapy), consolidation therapy, and maintenance therapy. In some patients, stem cell transplantation is recommended after initial therapy. In this study, researchers want to know if using the drug blinatumomab in addition to standard consolidation chemotherapy is more effective than the standard consolidation alone in patients newly diagnosed with B-cell ALL that is negative for the BCR/ABL gene fusion. (The BCR/ABL gene fusion is an abnormality that fuels the growth of some leukemias.)

Blinatumomab is a form of immunotherapy. It is already FDA approved to treat recurrent or chemotherapy-resistant B-cell ALL, and to treat patients with B-cell ALL who are in remission but have persistent low-level leukemia (called minimal residual disease). It is given intravenously (by vein).

In this study, patients who have persistent low-level leukemia after initial treatment will receive blinatumomab. Patients who are in remission without detectable leukemia after initial treatment will be randomly assigned to receive blinatumomab or not to receive blinatumomab, in addition to standard ALL treatment, as part of consolidation therapy.

Eligibility

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

  • Patients must be newly diagnosed with B-cell ALL that is negative for the BCR/ABL fusion.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients aged 30 to 70.

For more information about this study and to inquire about eligibility, please contact Dr. Mark Geyer at 212-639-3290.

Protocol

18-440

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators