Acute Myeloid Leukemia Clinical Trial
Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
This was an exploratory Phase 2, open label, randomized, multicenter , parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.
The primary efficacy endpoint was to assess whether dociparstat in conjunction with standard induction therapy for AML increased the complete remission rate based on the International Working Group AML response criteria.
A total of 75 subjects were to be randomized in a 1:1:1 ratio to 1 of the following treatment groups:
Group 1: cytarabine + idarubicin
Group 2: cytarabine + idarubicin + dociparstat 0.125 mg/kg/hr
Group 3: cytarabine + idarubicin + dociparstat 0.25 mg/kg/hr
Subjects received up to 2 induction cycles and up to 2 consolidation cycles and participated in the study for up to 18 months. Clinical laboratory tests were conducted routinely, and bone marrow aspirates and biopsies were performed during the induction cycles. Safety was monitored through adverse events and clinical laboratory results.
Subjects had to meet all the following criteria to be eligible for enrollment in this study:
Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML).
Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Subjects who met any of the following criteria were not eligible for enrollment in this study:
Had acute promyelocytic leukemia
Had prior chemotherapy for AML.
Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome.
Had central nervous system (CNS) leukemia.
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There are 23 Locations for this study
La Jolla California, 92093, United States
Denver Colorado, 80218, United States
Washington District of Columbia, 20037, United States
Indianapolis Indiana, 46237, United States
Sioux City Iowa, 51101, United States
Louisville Kentucky, 40207, United States
New Orleans Louisiana, 70112, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55407, United States
Saint Louis Missouri, 63110, United States
Albuquerque New Mexico, 87131, United States
Bronx New York, 10467, United States
Lake Success New York, 11042, United States
Cincinnati Ohio, 45267, United States
Portland Oregon, 97239, United States
Providence Rhode Island, 02903, United States
Charleston South Carolina, 29425, United States
Sioux Falls South Dakota, 57105, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84143, United States
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