Spots Global Cancer Trial Database for Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
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Trial Identification
Brief Title: Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
Official Title: A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
Study ID: NCT02873338
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, San Diego, Moores Cancer Center, La Jolla, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
George Washington University, Washington, District of Columbia, United States
Franciscan St. Francis Health, Indianapolis, Indiana, United States
June E. Nylen Cancer Center, Sioux City, Iowa, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Tulane University/Tulane Cancer Center, New Orleans, Louisiana, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Allina Health - Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
Montefiore Medical Center, Bronx, New York, United States
Northwell Health, Monter Cancer Center, Lake Success, New York, United States
University of Cincinnati, Cincinnati, Ohio, United States
Oregon Health & Science University Knight Cancer Institute, Portland, Oregon, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Tennessee Oncology/Sarah Cannon Research Institute, Nashville, Tennessee, United States
Baylor Research Institute/Baylor Sammons Cancer Center/Baylor University Medical Center, Dallas, Texas, United States
Methodist Healthcare System of San Antonio, San Antonio, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
Contact Details
Name: Stephen Marcus, MD
Affiliation: Cantex Pharmaceuticals Inc.
Role: STUDY_DIRECTOR
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