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Sponsored by: |
Gruppo Italiano Malattie EMatologiche dell'Adulto |
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Information provided by: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
ClinicalTrials.gov Identifier: | NCT00469560 |
Open label, single arm study on Deferasirox treatment in MDS patients with chronic transfusional hemosiderosis.
Patients receive daily oral dosis of Deferasirox in order to eliminate the quantity of iron administered during transfusions and, if needed, to reduce the overload of already present iron.
After an screening phase in which patients are evaluated according to eligibility criteria, a one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndromes Hemosiderosis |
Drug: Deferasirox |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open Label, Multicenter Study to Evaluate Safety/Tolerability and Efficacy of Deferasirox (ICL670) in Myelodysplastic Syndrome Patients With Chronic Transfusional Hemosiderosis. |
Estimated Enrollment: | 158 |
Study Start Date: | June 2007 |
It has been widely shown that an appropriate chelating therapy in chronic anemias transfusion dependent can prevent the overstock of iron and can reduce the already existing overstock reducing, then, the co-morbidity and improving survival.
In particular, some authors have shown in MDS affected patients undergoing intensive chelating therapy with deferoxamine haematological recovery with a reduction of the need of transfusions.
With the present study, we plan to evaluate the safety and efficacy of a therapy with the new oral chelating Deferasirox in MDS patients with transfusional hemosiderosis.
This is an open label, single arm study on Deferasirox treatment in MDS patients with chronic transfusional hemosiderosis.
Patients will receive daily oral dosis of Deferasirox in order to eliminate the quantity of iron administered during transfusions and, if needed, to reduce the overload of already present iron.
After an screening phase in which patients are evaluated according to eligibility criteria, a one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marco VIGNETTI, Dr. | +39 06 441639831 | m.vignetti@gimema.it |
Contact: Paola FAZI, Dr. | +39 06 441639830 | p.fazi@gimema.it |
Italy | |
Oncoematologia "A.O.R.N. S'Anna e S.Sebastiano" | Not yet recruiting |
Caserta, Italy | |
Contact: Antonio ABBADESSA | |
Ematologia- Università degli Studi "La Sapienza" | Recruiting |
Roma, Italy | |
Contact: Giuliana ALIMENA, Pr. | |
Università degli Studi di Tor Vergata | Recruiting |
Roma, Italy | |
Contact: Sergio AMADORI | |
Ospedale "A. Businco" | Recruiting |
Cagliari, Italy | |
Contact: Emanuele ANGELUCCI | |
Policlinico di Careggi, Università delgi studi di Firenze | Recruiting |
Firenze, Italy | |
Contact: Alberto BOSI | |
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza | Not yet recruiting |
San Giovanni Rotondo, Italy | |
Contact: Nicola CASCAVILLA | |
Ospedale Civile SS. Giovanni e Paolo | Not yet recruiting |
Venezia, Italy | |
Contact: Teodoro CHISESI | |
US Dipartimentale Centro per le Malattie del Sangue | Not yet recruiting |
Castelfranco Veneto, Italy | |
Contact: Ercole DE BIASI | |
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli | Recruiting |
Bologna, Italy | |
Contact: Giovanni MARTINELLI | |
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto" | Not yet recruiting |
Catania, Italy | |
Contact: Francesco Di Raimondo | |
Clinica Ematologica - Università degli Studi | Not yet recruiting |
Genova, Italy | |
Contact: Marco GOBBI | |
CTMO-Ematologia Ospedale Binaghi | Not yet recruiting |
Cagliari, Italy | |
Contact: Giorgio LA NASA | |
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese | Not yet recruiting |
Siena, Italy | |
Contact: Francesco LAURIA | |
Università Cattolica del Sacro Cuore | Not yet recruiting |
Roma, Italy | |
Contact: Giuseppe LEONE | |
SOC EMATOLOGIA ASO SS Antonio e Biagio | Not yet recruiting |
Alessandria, Italy | |
Contact: Alessandro LEVIS | |
Clinica Ematol Università di Perugia, Policlinico Monteluce | Not yet recruiting |
Perugia, Italy | |
Contact: Cristina Mecucci | |
Divisione di Ematologia e TMO - Ospedale "A. Cardarelli "- Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" | Not yet recruiting |
Napoli, Italy | |
Contact: Felicetto FERRARA |
Principal Investigator: | Emanuele ANGELUCCI, Pr. | Ospedale "A. Businco", Cagliari |
Study ID Numbers: | MDS0306 |
Study First Received: | May 3, 2007 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00469560 |
Health Authority: | Italy: The Italian Medicines Agency |
MDS Chronic transfusional hemosiderosis Deferasirox Low and intermediate I risk (IPSS score) Myelodysplastic syndrome and transfusion-induced hemosiderosis. |
Myelodysplastic syndromes Metabolic Diseases Precancerous Conditions Hematologic Diseases Deferasirox Myelodysplastic Syndromes Myelodysplasia |
Iron Metabolism Disorders Preleukemia Hemosiderosis Iron Overload Bone Marrow Diseases Metabolic disorder Iron |
Neoplasms Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Syndrome Iron Chelating Agents Chelating Agents Pharmacologic Actions |