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Keep this study
Lead
Jazz Pharmaceuticals
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.
Age
60–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects had to meet all the following criteria to be eligible for enrollment in this study:
1. Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML).
2. Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
You may not be if
1. Had acute promyelocytic leukemia
2. Had prior chemotherapy for AML.
3. Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome.
4. Had central nervous system (CNS) leukemia.
Clareo Health | Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
