Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT02873338

Run by

Jazz Pharmaceuticals

People needed

75

Starts

2016-08-01

Expected to finish

2019-06-01

Last updated by the study team

2023-09-07

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 D.C., 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 — St Louis, Missouri, United States
• New Mexico Cancer Care Alliance — Albuquerque, New Mexico, United States
• Northwell Health, Monter Cancer Center — Lake Success, New York, United States
• Montefiore Medical Center — The Bronx, 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

Full record on ClinicalTrials.gov

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