Study on Daunorubicin and Cytarabine With or Without Uproleselan for Treating Older Adults with Acute Myeloid Leukemia

Program Overview

The purpose of this study is to find out if adding uproleselan to the chemotherapy drugs daunorubicin and cytarabine can help treat older adults with acute myeloid leukemia (AML) more effectively. Chemotherapy drugs like daunorubicin and cytarabine work by stopping cancer cells from growing, dividing, or spreading. Uproleselan may help prevent the cancer from coming back or getting worse. This study will compare the effectiveness of the combination of these drugs to the standard treatment of daunorubicin and cytarabine alone.

Description

The study is divided into two phases. In Phase II, researchers will compare how long patients live without the cancer getting worse when treated with daunorubicin, cytarabine, and uproleselan versus daunorubicin and cytarabine alone. In Phase III, the focus will be on comparing the overall survival of patients receiving the two different treatments.

Secondary goals include:

• Determining the rates of complete remission and other types of remission for each treatment.
• Evaluating the overall survival and remission duration for each treatment.
• Describing the frequency and severity of side effects for each treatment.
• Examining how different patient and disease characteristics affect treatment outcomes.

The study will also explore how specific genetic features of the cancer relate to treatment response and survival.

Participants will be randomly assigned to one of two groups:

• Group 1 (Standard Treatment):

  • Induction Phase: Receive daunorubicin intravenously (IV) on days 1-3 and cytarabine continuously IV over 7 days. If cancer remains, a second round of treatment is given.
  • Consolidation Phase: Receive cytarabine IV over 3 hours on days 1-5, repeated every 28 days for up to 3 cycles if the cancer does not progress or cause unacceptable side effects.

• Group 2 (Experimental Treatment):

  • Induction Phase: Receive uproleselan IV on day 1 and then every 12 hours on days 2-10, along with daunorubicin IV on days 2-4 and cytarabine continuously IV over 7 days. If cancer remains, a second round of treatment is given.
  • Consolidation Phase: If remission is achieved, receive uproleselan IV on day 1 and every 12 hours on days 2-8, and cytarabine IV over 3 hours on days 2-6, repeated every 28 days for up to 3 cycles if the cancer does not progress or cause unacceptable side effects.

All participants will undergo heart scans and bone marrow tests throughout the study. After completing the treatment, patients will have follow-up visits every 2 months for the first year, every 3 months in the second year, and every 6 months for up to 5 years.

Eligibility Criteria

Locations