Clinical Trial: Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multicentre, Open-label, Randomized Phase II Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 International Prognostic

Brief Summary:

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:

  • Haematologic response, bases on the following parameters: platelets, and neutrophils according to International Working Group (IWG) Criteria.
  • Medullary and cytogenetic response according to International Working Group (IWG) 2006 criteria.
  • The effect of treatment response on quality of life, through the Functional Assessment of Cancer Therapy-Anemia (FACT-an) questionnaire.
  • Overall survival, Event-Free Survival and the Acute Leukaemia Transformation Rate.

Detailed Summary:
Sponsor: Asociación Andaluza de Hematología y Hemoterapia

Current Primary Outcome: Erythroid haematologic response [ Time Frame: Approximately the primary outcome is measured on days 0, 252 and 504 (basal, cycle 9 and 18 (each cicle has 28 days +/-3 days)) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Haematologic response [ Time Frame: 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). ]
    Haematologic response, bases on the following parameters: platelets, and neutrophils according to International Working Group (IWG) Criteria.
  • Medullary and cytogenetic response [ Time Frame: Approximately this secondary outcome is measured on days 252 and 504 (basal, cycle 9 and 18 (each cicle has 28 days +/-3 days)). ]
    Medullary and cytogenetic response according to International Working Group (IWG) 2006 criteria.
  • Quality of life [ Time Frame: Approximately this secondary outcome is measured on days 252 and 504 (basal, cycle 9 and 18 (each cicle has 28 days +/-3 days)). ]
    The effect of treatment response on quality of life, through the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire.
  • Overall survival [ Time Frame: 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) ]
    Overall survival
  • Event-Free Survival [ Time Frame: 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
  • Acute Leukaemia Transformation Rate [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Asociación Andaluza de Hematología y Hemoterapia

Dates:
Date Received: April 13, 2011
Date Started: November 2010
Date Completion:
Last Updated: January 25, 2016
Last Verified: January 2016