NCT04602273

Treatment of High Risk Myelodysplastic Syndromes (MDS) Not Candidates for Allogeneic Transplantation of Hematopoietic Progenitors (ALO-HSCT)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An observational, non-interventional, prospective and multicenter study of Azacitidine in newly diagnosed High Risk Myelodysplastic Syndromes. Primary objectives are to asses mutational status of target genes by Next Generation Sequencing, to evaluate prognostic value of geriatric assessment scales and to evaluate overall survival. The main hypothesis is that mutation status of target genes and geriatric scales have statistical significant impact on overall survival. Study time points will be at diagnosis, 6, 12, 18 and 24 months, always taking into account the routine clinical practice, when sample to assess mutational status will be collected. Geriatric assessment will only be performed at diagnosis. Upon the signature of informed consent and the checking of inclusion criteria, patients will receive treatment with Azacitidine 75 mg/sqm on a 28 days based cycles (both 7-0-0 and 5-0-2 regimens are allowed) until disease progression, unacceptable toxicity or investigator decision. 150 patients are expected to be recruited at study sites.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Azacitidine Injection [Vidaza]

Timeline

• Start date: 2016-12-12
• Primary completion: 2020-11-01
• Completion: 2021-06-30
• First posted: 2020-10-26
• Last updated: 2020-10-26

Locations

1 site across 1 country: Spain