Spots Global Cancer Trial Database for Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.
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Trial Identification
Brief Title: Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.
Official Title: A 2-year, Multi-center, Phase II, Open-label, Fixed-dose, Randomized Comparative Trial of Azacitidine, With or Without Deferasirox in Patients With Higher Risk Myelodysplastic Syndromes
Study ID: NCT02159040
Conditions
Study Description
Brief Summary: The primary objective of the study is to compare the overall response rate (inclusive of complete response, partial response and hematologic improvement) per IWG 2006 criteria in patients with higher risk MDS treated with azacitidine with or without deferasirox achieved over the course of one year. Hematologic improvement must be maintained for at least 8 weeks.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hematology Oncology Services of Arkansas HOSA 2, Little Rock, Arkansas, United States
City of Hope National Medical Center Oncology, Duarte, California, United States
University of Maryland Medical Center UM Greenbaum Cancer Ctr (2), Baltimore, Maryland, United States
Rochester General Hospital / Lipson Cancer Center Lipson Cancer Center, Rochester, New York, United States
The Jones Clinic, Germantown, Tennessee, United States
Utah Cancer Specialists IHO Corp, Salt Lake City, Utah, United States
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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