Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Acute Myeloid Leukemia

In brief

This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

Key facts

Study ID

NCT03701308

Run by

National Cancer Institute (NCI)

People needed

267

Starts

2019-03-28

Expected to finish

2026-10-26

Last updated by the study team

2026-01-21

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.
• No prior chemotherapy for myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN) or AML including hypomethylating agents (e.g. azacitidine and decitabine), ruxolitinib or lenalidomide with the following exceptions:
• Emergency leukapheresis
• Hydroxyurea
• Growth factor/cytokine support
• All-trans retinoic acid (ATRA)
• Single dose of intrathecal cytarabine and/or methotrexate for patients undergoing lumbar puncture to evaluate for CNS involvement.
• Age >= 60 years.
• Total bilirubin =< 3 x upper limit of normal (ULN)
• Creatinine < 3 x upper limit of normal (ULN) OR creatinine clearance >= 30 mL/min/1.73m\^2

Where it is running

• Community Cancer Institute — Clovis, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Delaware Clinical and Laboratory Physicians PA — Newark, Delaware, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
• Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho, United States
• Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
• Walter Knox Memorial Hospital — Emmett, Idaho, United States
• Idaho Urologic Institute-Meridian — Meridian, Idaho, United States
• Saint Alphonsus Cancer Care Center-Nampa — Nampa, Idaho, United States
• Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
• Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Illinois CancerCare-Canton — Canton, Illinois, United States
• Memorial Hospital of Carbondale — Carbondale, Illinois, United States
• SIH Cancer Institute — Carterville, Illinois, United States
• Illinois CancerCare-Carthage — Carthage, Illinois, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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