A Phase III Study of Uproleselan plus Chemotherapy versus Chemotherapy Alone in Patients with Recurrent or Persistent Acute Myeloid Leukemia

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Full Title

A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered with Chemotherapy versus Chemotherapy Alone in Patients with Relapsed/Refractory Acute Myeloid Leukemia (WIRB)

Purpose

The purpose of this study is to see if adding the investigational drug uproleselan to standard chemotherapy is more effective than standard chemotherapy alone for patients with acute myeloid leukemia (AML) that has come back or continued to grow despite prior treatment.

Uproleselan works by preventing a protein called E-selectin from binding with cancer cells in the bone marrow. It is designed to disrupt the mechanisms by which leukemia cells become resistant to therapy. It is hoped that uproleselan can make AML cells more vulnerable to the cancer-killing effects of chemotherapy.

Patients in this study will be randomly assigned to receive chemotherapy plus either uproleselan or a placebo (saline solution). Treatments are given intravenously (by vein).

Eligibility

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

  • Patients must have recurrent or persistent AML.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 to 75.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 212-639-3842.

Protocol

19-389

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators