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

NCT04602273 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2020-10-26

No results posted yet for this study

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

Interventions

DRUG

Azacitidine Injection [Vidaza]

Sponsors & Collaborators

  • Hospital Son Llatzer

    collaborator OTHER

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Celgene Corporation

    collaborator INDUSTRY

  • Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

    lead OTHER

Principal Investigators

  • Joan Bargay, MD PhD · Hospital Son Llatzer

  • Lurdes Zamora, PhD · Germans Trias i Pujol Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2020-11-01
Completion
2021-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04602273 on ClinicalTrials.gov