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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 171 Locations for this study
Little Rock Arkansas, 72205, United States
Clovis California, 93611, United States
La Jolla California, 92093, United States
Loma Linda California, 92354, United States
Los Angeles California, 90048, United States
Hartford Connecticut, 06105, United States
New Haven Connecticut, 06520, United States
Newark Delaware, 19713, United States
Newark Delaware, 19713, United States
Newark Delaware, 19713, United States
Newark Delaware, 19718, United States
Boise Idaho, 83706, United States
Boise Idaho, 83712, United States
Caldwell Idaho, 83605, United States
Coeur d'Alene Idaho, 83814, United States
Emmett Idaho, 83617, United States
Meridian Idaho, 83642, United States
Nampa Idaho, 83687, United States
Post Falls Idaho, 83854, United States
Sandpoint Idaho, 83864, United States
Bloomington Illinois, 61704, United States
Canton Illinois, 61520, United States
Carbondale Illinois, 62902, United States
Carterville Illinois, 62918, United States
Carthage Illinois, 62321, United States
Centralia Illinois, 62801, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Eureka Illinois, 61530, United States
Evanston Illinois, 60201, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Glenview Illinois, 60026, United States
Highland Park Illinois, 60035, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Maywood Illinois, 60153, United States
New Lenox Illinois, 60451, United States
O'Fallon Illinois, 62269, United States
Orland Park Illinois, 60462, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peru Illinois, 61354, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62781, United States
Swansea Illinois, 62226, United States
Indianapolis Indiana, 46202, United States
Ames Iowa, 50010, United States
Ames Iowa, 50010, United States
Boone Iowa, 50036, United States
Fort Dodge Iowa, 50501, United States
Iowa City Iowa, 52242, United States
Jefferson Iowa, 50129, United States
Marshalltown Iowa, 50158, United States
Sioux City Iowa, 51101, United States
Kansas City Kansas, 66160, United States
Lawrence Kansas, 66044, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70121, United States
Bangor Maine, 04401, United States
Brewer Maine, 04412, United States
Boston Massachusetts, 02215, United States
Adrian Michigan, 49221, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49009, United States
Monroe Michigan, 48162, United States
Muskegon Michigan, 49444, United States
Norton Shores Michigan, 49444, United States
Reed City Michigan, 49677, United States
Saint Joseph Michigan, 49085, United States
Traverse City Michigan, 49684, United States
Wyoming Michigan, 49519, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maple Grove Minnesota, 55369, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Minneapolis Minnesota, 55454, United States
Monticello Minnesota, 55362, United States
New Ulm Minnesota, 56073, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Wyoming Minnesota, 55092, United States
Bonne Terre Missouri, 63628, United States
Cape Girardeau Missouri, 63703, United States
Cape Girardeau Missouri, 63703, United States
Creve Coeur Missouri, 63141, United States
Farmington Missouri, 63640, United States
Jefferson City Missouri, 65109, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63129, United States
Saint Louis Missouri, 63131, United States
Saint Louis Missouri, 63136, United States
Saint Peters Missouri, 63376, United States
Sainte Genevieve Missouri, 63670, United States
Sullivan Missouri, 63080, United States
Sunset Hills Missouri, 63127, United States
Anaconda Montana, 59711, United States
Billings Montana, 59101, United States
Bozeman Montana, 59715, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59802, United States
Missoula Montana, 59804, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89169, United States
Lebanon New Hampshire, 03756, United States
Morristown New Jersey, 07960, United States
Summit New Jersey, 07902, United States
Lake Success New York, 11042, United States
Manhasset New York, 11030, United States
New Hyde Park New York, 11040, United States
New York New York, 10029, United States
Rochester New York, 14642, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Greenville North Carolina, 27834, United States
Wilkesboro North Carolina, 28659, United States
Winston-Salem North Carolina, 27157, United States
Bismarck North Dakota, 58501, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Columbus Ohio, 43210, United States
Perrysburg Ohio, 43551, United States
Toledo Ohio, 43623, United States
Toledo Ohio, 43623, United States
Oklahoma City Oklahoma, 73104, United States
Baker City Oregon, 97814, United States
Ontario Oregon, 97914, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Danville Pennsylvania, 17822, United States
Wilkes-Barre Pennsylvania, 18711, United States
Providence Rhode Island, 02903, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29607, United States
Greenville South Carolina, 29615, United States
Sioux Falls South Dakota, 57104, United States
Sioux Falls South Dakota, 57117, United States
Nashville Tennessee, 37232, United States
Kennewick Washington, 99336, United States
Eau Claire Wisconsin, 54701, United States
Marshfield Wisconsin, 54449, United States
Minocqua Wisconsin, 54548, United States
New Richmond Wisconsin, 54017, United States
Rice Lake Wisconsin, 54868, United States
Stevens Point Wisconsin, 54482, United States
Weston Wisconsin, 54476, United States
Cody Wyoming, 82414, United States
Sheridan Wyoming, 82801, United States
How clear is this clinincal trial information?