Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2008-003207-30 | Registry Identifier | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study has been designed to establish the efficacy and safety of deferasirox in patients with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant (HSCT).
The purpose of this study is to assess the mean change in serum ferritin after 52 weeks of treatment with deferasirox, in patients with iron overload (defined with serum ferritin levels ≥ 1000 ng/ml and receiving > 20 RBC concentrates) after allogeneic HSCT.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICL670 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deferasirox | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in serum ferritin | after 52 weeks of treatment with deferasirox |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the no. of sideroblasts, assessed by Perls staining | after 52 weeks of treatment with deferasirox | |
| Mean change in liver iron concentration (LIC), assessed by liver MRI. | after 52 weeks of treatment with deferasirox |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may app
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Andalucia | Spain | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24997153 | Derived | Vallejo C, Batlle M, Vazquez L, Solano C, Sampol A, Duarte R, Hernandez D, Lopez J, Rovira M, Jimenez S, Valcarcel D, Belloch V, Jimenez M, Jarque I; Subcommittee of Non-Infectious Complications of the Grupo Espanol de Trasplante Hematopoyetico (GETH). Phase IV open-label study of the efficacy and safety of deferasirox after allogeneic stem cell transplantation. Haematologica. 2014 Oct;99(10):1632-7. doi: 10.3324/haematol.2014.105908. Epub 2014 Jul 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Incidence of chronic graft-versus-host disease ("limited" or "extensive", according to Shulman criteria) | up to 52 weeks of study |
| Incidence of infections (bacterial, viral, or fungal) | up to 52 weeks of study |
| Incidence of venous occlusive disease during the study | up to 52 weeks of study |
| Asturias |
| Spain |
| Novartis Investigative Site | Canarias | Spain |
| Novartis Investigative Site | Castilla Y Leon | Spain |
| Novartis Investigative Site | Cataluna | Spain |
| Novartis Investigative Site | Comunidad Valenciana | Spain |
| Novartis Investigative Site | Islas Baleares | Spain |
| Novartis Investigative Site | Madrid | Spain |
| Novartis Investigative Site | Murcia | Spain |
| ID | Term |
|---|---|
| D019190 | Iron Overload |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077588 | Deferasirox |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided