Clincosm LogoSign in Get a demo

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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Suspended
CT.gov ID
NCT03701308
Collaborator
(none)
670
Enrollment
188
Locations
2
Arms
82.5
Anticipated Duration (Months)
3.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:

  1. 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.

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

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

  4. 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:

  1. 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.

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

  3. 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.

  4. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
670 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy
Actual Study Start Date :
Jan 16, 2019
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (daunorubicin, cytarabine)

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 1-3 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.

Drug: Cytarabine
Given IV
Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Beta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453

    • Drug: Daunorubicin
    Given IV
    Other Names:
  • Daunomycin
  • Daunorrubicina
  • DNR
  • Leukaemomycin C
  • Rubidomycin
  • Rubomycin C

    		•
    Experimental: Arm II (uproleselan, daunorubicin, cytarabine)

    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.

    Drug: Cytarabine
    Given IV
    Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Beta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453

    • Drug: Daunorubicin
    Given IV
    Other Names:
  • Daunomycin
  • Daunorrubicina
  • DNR
  • Leukaemomycin C
  • Rubidomycin
  • Rubomycin C

    • Drug: Uproleselan
    Given IV
    Other Names:
  • GMI-1271

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Event-free survival (EFS) (Phase II) [Up to 5 years]

      EFS is defined as the time from the date of randomization to the first of failure to achieve a complete remission (CR)/ CR with incomplete blood count recovery (CRi) during induction, relapse, or death due to any cause, with patients last known to be alive and event-free censored at the date of last contact.

    2. Overall survival (OS) (Phase III) [Up to 5 years]

      Will be measured from the date of randomization to death from any cause, with patients last known to be alive censored at the date of last contact.

    Secondary Outcome Measures

    1. EFS rate [Up to 1 year]

      Will be formally tested hierarchically in a confirmatory setting at an overall one sided alpha of 0.025 level at the same time as the primary endpoint. Both hazard ratio and p-value for EFS will be presented.

    2. Impact of off-protocol transplantation [Up to 5 years]

      Sensitivity analyses will be conducted. In addition, the proportion of patients who received transplantation in the two arms will be summarized and compared using a chi-square test.

    3. Consistency of the treatment effect among each subgroup [From baseline up to 5 years]

      Non-parametric methods such as Kaplan-Meier and log-rank tests will be used within each subgroup. Univariate/multivariate Cox models will be fit within each subgroups; hazard ratios will be used to quantify the treatment effect within each subgroup, along with the 95% confidence intervals.

    4. Disease-free survival (DFS) [Time from achieving a complete response to time of relapse or death, assessed up to 5 years]

    5. Complete remission (CR) and overall response rate [Up to 5 years]

    6. Incidence of adverse events [Up to 5 years]

      Will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 5.0. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

    7. Prediction of CR, EFS, DFS, and OS by pretreatment characteristics such as age, morphology, cytogenetics, immunophenotype, molecular genetic features, WBC count and hemogram, and performance status with clinical outcomes [Up to 5 years]

      The associations between these baseline factors and CR, EFS, DFS, and OS will be analyzed using Kaplan-Meier curves, log-rank test, contingency table and chi-square test whenever appropriate. Multivariable analysis including Cox proportional hazards models and logistic regression models will be used as well to evaluate the associations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 Community Cancer Institute Clovis California United States 93611
    3 UC San Diego Moores Cancer Center La Jolla California United States 92093
    4 Loma Linda University Medical Center Loma Linda California United States 92354
    5 Cedars Sinai Medical Center Los Angeles California United States 90048
    6 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    7 Yale University New Haven Connecticut United States 06520
    8 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
    9 Helen F Graham Cancer Center Newark Delaware United States 19713
    10 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    11 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    12 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    13 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    14 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    15 Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho United States 83814
    16 Walter Knox Memorial Hospital Emmett Idaho United States 83617
    17 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
    18 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    19 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
    20 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
    21 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    22 Illinois CancerCare-Canton Canton Illinois United States 61520
    23 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    24 SIH Cancer Institute Carterville Illinois United States 62918
    25 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    26 Centralia Oncology Clinic Centralia Illinois United States 62801
    27 Northwestern University Chicago Illinois United States 60611
    28 University of Illinois Chicago Illinois United States 60612
    29 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    30 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    31 Decatur Memorial Hospital Decatur Illinois United States 62526
    32 Crossroads Cancer Center Effingham Illinois United States 62401
    33 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    34 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    35 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    36 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    37 NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois United States 60026
    38 NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois United States 60035
    39 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    40 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    41 Loyola University Medical Center Maywood Illinois United States 60153
    42 UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois United States 60451
    43 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    44 University of Chicago Medicine-Orland Park Orland Park Illinois United States 60462
    45 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    46 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    47 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    48 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    49 Illinois CancerCare-Peru Peru Illinois United States 61354
    50 Valley Radiation Oncology Peru Illinois United States 61354
    51 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    52 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    53 Springfield Clinic Springfield Illinois United States 62702
    54 Memorial Medical Center Springfield Illinois United States 62781
    55 Southwest Illinois Health Services LLP Swansea Illinois United States 62226
    56 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    57 Mary Greeley Medical Center Ames Iowa United States 50010
    58 McFarland Clinic PC - Ames Ames Iowa United States 50010
    59 McFarland Clinic PC-Boone Boone Iowa United States 50036
    60 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
    61 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    62 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
    63 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
    64 Siouxland Regional Cancer Center Sioux City Iowa United States 51101
    65 University of Kansas Cancer Center Kansas City Kansas United States 66160
    66 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    67 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    68 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    69 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    70 Wesley Medical Center Wichita Kansas United States 67214
    71 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    72 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    73 Eastern Maine Medical Center Bangor Maine United States 04401
    74 Lafayette Family Cancer Center-EMMC Brewer Maine United States 04412
    75 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    76 Hickman Cancer Center Adrian Michigan United States 49221
    77 Henry Ford Hospital Detroit Michigan United States 48202
    78 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    79 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    80 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    81 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    82 Ascension Borgess Cancer Center Kalamazoo Michigan United States 49009
    83 Toledo Clinic Cancer Centers-Monroe Monroe Michigan United States 48162
    84 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    85 Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan United States 49444
    86 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    87 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    88 Munson Medical Center Traverse City Michigan United States 49684
    89 Metro Health Hospital Wyoming Michigan United States 49519
    90 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    91 Mercy Hospital Coon Rapids Minnesota United States 55433
    92 Essentia Health Cancer Center Duluth Minnesota United States 55805
    93 Fairview Southdale Hospital Edina Minnesota United States 55435
    94 Unity Hospital Fridley Minnesota United States 55432
    95 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
    96 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    97 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    98 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    99 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    100 Health Partners Inc Minneapolis Minnesota United States 55454
    101 Monticello Cancer Center Monticello Minnesota United States 55362
    102 New Ulm Medical Center New Ulm Minnesota United States 56073
    103 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    104 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    105 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
    106 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    107 Regions Hospital Saint Paul Minnesota United States 55101
    108 United Hospital Saint Paul Minnesota United States 55102
    109 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    110 Lakeview Hospital Stillwater Minnesota United States 55082
    111 Ridgeview Medical Center Waconia Minnesota United States 55387
    112 Rice Memorial Hospital Willmar Minnesota United States 56201
    113 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    114 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
    115 Parkland Health Center-Bonne Terre Bonne Terre Missouri United States 63628
    116 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    117 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    118 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    119 Parkland Health Center - Farmington Farmington Missouri United States 63640
    120 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    121 Washington University School of Medicine Saint Louis Missouri United States 63110
    122 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    123 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    124 Siteman Cancer Center at Christian Hospital Saint Louis Missouri United States 63136
    125 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    126 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    127 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    128 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    129 Community Hospital of Anaconda Anaconda Montana United States 59711
    130 Billings Clinic Cancer Center Billings Montana United States 59101
    131 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    132 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    133 Great Falls Clinic Great Falls Montana United States 59405
    134 Saint Peter's Community Hospital Helena Montana United States 59601
    135 Kalispell Regional Medical Center Kalispell Montana United States 59901
    136 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    137 Community Medical Hospital Missoula Montana United States 59804
    138 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    139 OptumCare Cancer Care at Charleston Las Vegas Nevada United States 89102
    140 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    141 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    142 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    143 Morristown Medical Center Morristown New Jersey United States 07960
    144 Overlook Hospital Summit New Jersey United States 07902
    145 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    146 North Shore University Hospital Manhasset New York United States 11030
    147 Long Island Jewish Medical Center New Hyde Park New York United States 11040
    148 Mount Sinai Hospital New York New York United States 10029
    149 University of Rochester Rochester New York United States 14642
    150 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    151 Duke University Medical Center Durham North Carolina United States 27710
    152 East Carolina University Greenville North Carolina United States 27834
    153 Wake Forest Baptist Health - Wilkes Medical Center Wilkesboro North Carolina United States 28659
    154 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    155 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    156 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    157 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    158 Case Western Reserve University Cleveland Ohio United States 44106
    159 MetroHealth Medical Center Cleveland Ohio United States 44109
    160 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    161 Mercy Health Perrysburg Cancer Center Perrysburg Ohio United States 43551
    162 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    163 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
    164 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    165 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
    166 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
    167 Providence Portland Medical Center Portland Oregon United States 97213
    168 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    169 Geisinger Medical Center Danville Pennsylvania United States 17822
    170 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    171 Rhode Island Hospital Providence Rhode Island United States 02903
    172 Medical University of South Carolina Charleston South Carolina United States 29425
    173 Saint Francis Hospital Greenville South Carolina United States 29601
    174 Saint Francis Cancer Center Greenville South Carolina United States 29607
    175 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    176 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    177 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    178 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    179 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    180 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    181 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    182 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    183 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    184 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    185 Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin United States 54482
    186 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    187 Billings Clinic-Cody Cody Wyoming United States 82414
    188 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Geoffrey L Uy, Alliance for Clinical Trials in Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT03701308
    Other Study ID Numbers:
    • NCI-2018-02130
    • NCI-2018-02130
    • A041701
    • A041701
    • U10CA180821
    First Posted:
    Oct 10, 2018
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Cytarabine
    Daunorubicin

    Study Results

    No Results Posted as of Aug 18, 2022