Acute Myeloid Leukemia Clinical Trial

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

Summary

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.

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Full Description

PRIMARY OBJECTIVES:

I. Compare the event-free survival (EFS) of daunorubicin, cytarabine plus uproleselan versus daunorubicin and cytarabine in subjects >= age 60 with previously untreated acute myeloid leukemia. (Phase II) II. Compare the overall survival (OS) of the daunorubicin, cytarabine plus uproleselan to daunorubicin and cytarabine in this patient population. (Phase III)

SECONDARY OBJECTIVES:

I. Determine the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), complete remission with incomplete hematopoietic recovery (CRh) and cytogenetic complete remission (CCyR) for each chemotherapy regimen.

II. Determine the overall survival (OS), and remission duration of patients for each chemotherapy regimen.

III. Describe the frequency and severity of adverse events for patients for each chemotherapy regimen.

IV. Describe the interaction of pretreatment disease and patient characteristics including morphology, cytogenetics, molecular genetic features, white blood cell (WBC) count and hemogram, and performance status on clinical outcomes.

CORRELATIVE SCIENCE OBJECTIVES:

I. Correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters and with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens.

II. Correlate specific karyotype groups with selected molecular abnormalities and with measurable residual disease.

III. To determine karyotype changes at end of consolidation and the influence of the type of change (or no change) in karyotype at the end of consolidation on subsequent clinical course.

IV. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse on subsequent clinical course.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: INDUCTION: Patients receive daunorubicin intravenously (IV) on days 1-3 and cytarabine via continuous intravenous infusion (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 1-3 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.

ARM 2: 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.

After completion of study treatment, patients are followed up every 2 months for 1 year, every 3 months in year 2, and then every 6 months for up to 5 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion 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 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 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.
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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

670

Study ID:

NCT03701308

Recruitment Status:

Suspended

Sponsor:

National Cancer Institute (NCI)

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There are 171 Locations for this study

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University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Community Cancer Institute
Clovis California, 93611, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
Loma Linda University Medical Center
Loma Linda California, 92354, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford Connecticut, 06105, United States
Yale University
New Haven Connecticut, 06520, United States
Delaware Clinical and Laboratory Physicians PA
Newark Delaware, 19713, United States
Helen F Graham Cancer Center
Newark Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett Idaho, 83617, United States
Idaho Urologic Institute-Meridian
Meridian Idaho, 83642, United States
Saint Alphonsus Medical Center-Nampa
Nampa Idaho, 83686, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls Idaho, 83854, United States
Kootenai Cancer Clinic
Sandpoint Idaho, 83864, United States
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States
Illinois CancerCare-Canton
Canton Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale Illinois, 62902, United States
SIH Cancer Institute
Carterville Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States
Centralia Oncology Clinic
Centralia Illinois, 62801, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Illinois
Chicago Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston Illinois, 60201, United States
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg Illinois, 61401, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview Illinois, 60026, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park Illinois, 60035, United States
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox Illinois, 60451, United States
Cancer Care Center of O'Fallon
O'Fallon Illinois, 62269, United States
University of Chicago Medicine-Orland Park
Orland Park Illinois, 60462, United States
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
Illinois CancerCare-Peru
Peru Illinois, 61354, United States
Valley Radiation Oncology
Peru Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States
Springfield Clinic
Springfield Illinois, 62702, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Southwest Illinois Health Services LLP
Swansea Illinois, 62226, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Mary Greeley Medical Center
Ames Iowa, 50010, United States
McFarland Clinic PC - Ames
Ames Iowa, 50010, United States
McFarland Clinic PC-Boone
Boone Iowa, 50036, United States
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge Iowa, 50501, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
McFarland Clinic PC-Jefferson
Jefferson Iowa, 50129, United States
McFarland Clinic PC-Marshalltown
Marshalltown Iowa, 50158, United States
Siouxland Regional Cancer Center
Sioux City Iowa, 51101, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Lafayette Family Cancer Center-EMMC
Brewer Maine, 04412, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Hickman Cancer Center
Adrian Michigan, 49221, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Mercy Health Saint Mary's
Grand Rapids Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Ascension Borgess Cancer Center
Kalamazoo Michigan, 49009, United States
Toledo Clinic Cancer Centers-Monroe
Monroe Michigan, 48162, United States
Mercy Health Mercy Campus
Muskegon Michigan, 49444, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores Michigan, 49444, United States
Spectrum Health Reed City Hospital
Reed City Michigan, 49677, United States
Marie Yeager Cancer Center
Saint Joseph Michigan, 49085, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Metro Health Hospital
Wyoming Michigan, 49519, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Essentia Health Cancer Center
Duluth Minnesota, 55805, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
Health Partners Inc
Minneapolis Minnesota, 55454, United States
Monticello Cancer Center
Monticello Minnesota, 55362, United States
New Ulm Medical Center
New Ulm Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud Minnesota, 56303, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming Minnesota, 55092, United States
Parkland Health Center-Bonne Terre
Bonne Terre Missouri, 63628, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau Missouri, 63703, United States
Siteman Cancer Center at West County Hospital
Creve Coeur Missouri, 63141, United States
Parkland Health Center - Farmington
Farmington Missouri, 63640, United States
Capital Region Southwest Campus
Jefferson City Missouri, 65109, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Siteman Cancer Center-South County
Saint Louis Missouri, 63129, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Siteman Cancer Center at Christian Hospital
Saint Louis Missouri, 63136, United States
Siteman Cancer Center at Saint Peters Hospital
Saint Peters Missouri, 63376, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve Missouri, 63670, United States
Missouri Baptist Sullivan Hospital
Sullivan Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills Missouri, 63127, United States
Community Hospital of Anaconda
Anaconda Montana, 59711, United States
Billings Clinic Cancer Center
Billings Montana, 59101, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
Saint Peter's Community Hospital
Helena Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Saint Patrick Hospital - Community Hospital
Missoula Montana, 59802, United States
Community Medical Hospital
Missoula Montana, 59804, United States
Nebraska Methodist Hospital
Omaha Nebraska, 68114, United States
OptumCare Cancer Care at Charleston
Las Vegas Nevada, 89102, United States
OptumCare Cancer Care at Fort Apache
Las Vegas Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas Nevada, 89169, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Overlook Hospital
Summit New Jersey, 07902, United States
Northwell Health/Center for Advanced Medicine
Lake Success New York, 11042, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11040, United States
Mount Sinai Hospital
New York New York, 10029, United States
University of Rochester
Rochester New York, 14642, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
East Carolina University
Greenville North Carolina, 27834, United States
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro North Carolina, 28659, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58122, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Mercy Health Perrysburg Cancer Center
Perrysburg Ohio, 43551, United States
Mercy Health - Saint Anne Hospital
Toledo Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo Ohio, 43623, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Saint Alphonsus Medical Center-Baker City
Baker City Oregon, 97814, United States
Saint Alphonsus Medical Center-Ontario
Ontario Oregon, 97914, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland Oregon, 97225, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre Pennsylvania, 18711, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Saint Francis Hospital
Greenville South Carolina, 29601, United States
Saint Francis Cancer Center
Greenville South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Marshfield Clinic-Minocqua Center
Minocqua Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond Wisconsin, 54017, United States
Marshfield Medical Center-Rice Lake
Rice Lake Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point Wisconsin, 54482, United States
Marshfield Medical Center - Weston
Weston Wisconsin, 54476, United States
Billings Clinic-Cody
Cody Wyoming, 82414, United States
Welch Cancer Center
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

670

Study ID:

NCT03701308

Recruitment Status:

Suspended

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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