A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults with Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Study on Reducing Acute Myeloid Leukemia (AML) Recurrence with Additional Treatment

Recruiting
60 years - 100 years
All
1 Location

Brief description of study.

The purpose of this study is to see if we lower the chance of AML returning or getting worse by adding a new drug to the usual combination of drugs.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Myeloid Leukemia
  • Age: 60 years - 100 years
  • Gender: All

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Diagnosis of acute myeloid leukemia (AML) based on 2017 World Health Organization (WHO) criteria excluding acute promyelocytic leukemia with PML-RARA.
    Note: Patients with myeloid sarcoma without bone marrow involvement, acute leukemia of ambiguous lineage or blast transformation of chronic myelogenous leukemia (CML) are not eligible.
  • No evidence of central nervous system involvement of AML.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1904708908 (A041701)

This study investigates whether adding an investigational medication to the usual treatment can lower the chances of acute myeloid leukemia (AML) returning or worsening. AML is a type of cancer that affects the blood and bone marrow, where blood cells are made. The study aims to find out if the additional treatment can improve outcomes for patients with AML.

Participants will receive either the standard treatment alone or the standard treatment plus the investigational medication. The study procedures include regular monitoring of health and responses to the treatment. A placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine, may be used for comparison.

  • Who can participate: Adults diagnosed with acute myeloid leukemia (AML) according to the 2017 WHO criteria can participate, except those with acute promyelocytic leukemia with PML-RARA. Participants must not have AML involvement in the central nervous system.
  • Study details: Participants will be assigned to receive either the usual treatment alone or in combination with the investigational medication. A placebo may be used for comparison, which is an inactive substance that looks like the investigational medication but does not contain any medicine.

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