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Primary Outcome Measures:
• To evaluate the efficacy of treatment with Azacitidine in patients with transfusion-dependent, low risk International Prognostic Scoring System (IPSS) 0 int-1, Myelodysplastic Syndrome (MDS) without chromosome 5 (5q) deletion. The main objective will be based on the erythroid haematologic response according to International Working Group (IWG) 2006 criteria.
Secondary Outcome Measures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Support treatment | No Intervention | Transfusional support will be applied for symptomatic anaemia using clinical discretion and chelation therapy when ferritin is ≥ 1000 μgr/ml with the chelating agents allowed. | |
| Azacitidine | Experimental | Azacitidine 75 mg/m2, for 5 days of each 20 day cycle. Transfusional support will be applied for symptomatic anaemia using clinical discretion and chelation therapy when ferritin is ≥ 1000 μgr/ml with the chelating agents allowed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine | Drug | Azacitidine 75 mg/m2, for 5 days of each 20 day cycle. Transfusional support will be applied for symptomatic anaemia using clinical discretion and chelation therapy when ferritin is ≥ 1000 μgr/ml with the chelating agents allowed |
| Measure | Description | Time Frame |
|---|---|---|
| Erythroid haematologic response | To evaluate the efficacy of treatment with Azacitidine in patients with transfusion-dependent, low risk International Prognostic Scoring System (IPSS) 0 or int-1, Myelodysplastic Syndrome (MDS) without chromosome 5 (5q) deletion. The main objective will be based on the erythroid haematologic response according to International Working Group (IWG) 2006 criteria. | Approximately the primary outcome is measured on days 0, 252 and 504 (basal, cycle 9 and 18 (each cicle has 28 days +/-3 days)) |
| Measure | Description | Time Frame |
|---|---|---|
| Haematologic response | Haematologic response, bases on the following parameters: platelets, and neutrophils according to International Working Group (IWG) Criteria. | The secondary outcome is measured on days 0, 28, 56, 84, 112, 140, 168, 196, 224, 252, 280, 308, 336, 364, 392, 420, 448, 476 and 504 (the measurement is performed at basal line and in every cycle (every 28 days +/-3 days) up to a maximum of 18 cycles). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Reina Sofía, Servicio de Hematología | Córdoba | Cordoba | 14004 | Spain | ||
| Hospital General de Jerez |
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| Medullary and cytogenetic response | Medullary and cytogenetic response according to International Working Group (IWG) 2006 criteria. | Approximately this secondary outcome is measured on days 252 and 504 (basal, cycle 9 and 18 (each cicle has 28 days +/-3 days)). |
| Quality of life | The effect of treatment response on quality of life, through the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. | Approximately this secondary outcome is measured on days 252 and 504 (basal, cycle 9 and 18 (each cicle has 28 days +/-3 days)). |
| Overall survival | Overall survival | The secondary outcome is measured from basal line until day 504 (average of days for 18 cycles), or until progresion, or until exitus... (from basal line until the end of the study) |
| Event-Free Survival | Event-Free Survival | The secondary outcome is measured from basal line until day 504 (average of days for 18 cycles), or until progresion, or until exitus... (from basal line until the end of the study) |
| Acute Leukaemia Transformation Rate | Acute Leukaemia Transformation Rate | The secondary outcome is measured from basal line until day 504 (average of days for 18 cycles), or until progresion, or until exitus... (from basal line until the end of the study) |
| Jerez de la Frontera |
| Cádiz |
| 11407 |
| Spain |
| Hospital Universitario San Cecilio | Granada | Granada | 18012 | Spain |
| Hospital Virgen de las Nieves | Granada | Granada | 18840 | Spain |
| Hospital Juan Ramón Jiménez | Huelva | Huelva | 21005 | Spain |
| Hospital Costa del Sol | Marbella | Malaga | 29603 | Spain |
| Hospital Carlos Haya | Málaga | Malaga | 29800 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Sevilla | 41013 | Spain |
| Hospital Universitario Virgen de Valme | Seville | Sevilla | 41014 | Spain |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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