Spots Global Cancer Trial Database for Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.
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Trial Identification
Brief Title: Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.
Official Title: An Open-label, Phase II, Randomized, Pilot Study to Assess the Effect in Term of Erythroid Improvement of Deferasirox Combined With Erythropoietin Compared to Erythropoietin Alone in Patients With low-and Int-1-risk Myelodysplastic Syndrome.
Study ID: NCT01868477
Study Description
Brief Summary: The primary purpose of this trial was is to assess the effect of treatment with deferasirox combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low- and int-1-risk myelodysplastic syndrome. The addition of deferasirox to erythropoietin can lead to a potential synergism with the reduction of reactive oxygen species, through both the NF-kB pathway and the control of free toxic iron. This may create a better environment in the bone marrow for a better response with erythropoietin. This study was designed to test in a prospective way the combination of deferasirox with erythropoietin in terms of their effect on hematopoiesis.
Detailed Description: This study did not meet the original enrollment objective of 60 patients and was terminated without extending enrollment past original planned LPFV of 31-Oct-2016.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Oran, , Algeria
Novartis Investigative Site, Sidi Bel abbes, , Algeria
Novartis Investigative Site, Caba, Buenos Aires, Argentina
Novartis Investigative Site, La Plata, Buenos Aires, Argentina
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Hamilton, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Beijing, Beijing, China
Novartis Investigative Site, Guangzhou, Guangdong, China
Novartis Investigative Site, Nanjing, Jiangsu, China
Novartis Investigative Site, Chengdu, Sichuan, China
Novartis Investigative Site, Hangzhou, Zhejiang, China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Duesseldorf, , Germany
Novartis Investigative Site, Lütten-Klein, , Germany
Novartis Investigative Site, Wuerzburg, , Germany
Novartis Investigative Site, Cagliari, CA, Italy
Novartis Investigative Site, Reggio Calabria, RC, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Badalona, Catalunya, Spain
Novartis Investigative Site, Girona, Catalunya, Spain
Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
Novartis Investigative Site, Gothenburg, , Sweden
Novartis Investigative Site, Linköping, , Sweden
Novartis Investigative Site, Lulea, , Sweden
Novartis Investigative Site, Stockholm, , Sweden
Novartis Investigative Site, Oldham, Lancashire, United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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