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Anti-metabolites

Daunorubicin + Cytarabine ± Uproleselan for Acute Myeloid Leukemia

Phase 2 & 3

Waitlist Available

Led By Geoffrey L Uy

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No activating mutation in the Fms-like tyrosine kinase-3 (FLT3) defined as a ratio of mutant to wild-type allele >= 0.05 by capillary electrophoresis or a variant allele fraction of >= 5% by next generation sequencing from either bone marrow or peripheral blood.

No evidence of central nervous system (CNS) involvement of AML.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing whether adding a drug called uproleselan to the standard chemotherapy drugs daunorubicin and cytarabine can improve the treatment of older adult patients with acute myeloid

Who is the study for?

This trial is for older adults with acute myeloid leukemia (AML), excluding those with certain types of AML like acute promyelocytic leukemia. Participants must not have a specific mutation in the FLT3 gene and should show no signs of AML in their central nervous system. They can receive emergency treatments like leukapheresis, hydroxyurea, or a single dose of intrathecal chemotherapy.

What is being tested?

The study compares the effectiveness of two treatment methods for AML: one group receives daunorubicin and cytarabine alone, while another gets these drugs plus uproleselan. The goal is to see if adding uproleselan improves outcomes by preventing cancer from worsening or returning.

What are the potential side effects?

Potential side effects include reactions related to chemotherapy such as nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, and possible heart complications from daunorubicin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer does not have a specific genetic mutation (FLT3).

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My acute myeloid leukemia has not spread to my brain or spinal cord.

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I am 60 years old or older.

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My kidney function is within the required range.

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I have been diagnosed with AML, not including certain types.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival (EFS) (Phase II)

Overall survival (OS) (Phase III)

Secondary study objectives

Consistency of the treatment effect among each subgroup

EFS rate

Transplantation

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (uproleselan, daunorubicin, cytarabine)Experimental Treatment8 Interventions

INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-8, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6. CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.

Group II: Arm I (daunorubicin, cytarabine)Active Control7 Interventions

INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-2 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiography

2013

Completed Phase 4

~11580

Biospecimen Collection

2004

Completed Phase 3

~2020