About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

370533 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.

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

Clinicaltrials.gov identifier NCT04602273

Recruitment Status Recruiting

First Posted October 26, 2020

Last update posted October 26, 2020

Study Description

Brief 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.

  • Condition or Disease:Myelodysplastic Syndromes
  • Intervention/Treatment: Drug: Azacitidine Injection [Vidaza]
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 150 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Treatment of High Risk Myelodysplastic Syndromes (MDS) Not Candidates for Allogeneic Transplantation of Hematopoietic Progenitors (ALO-HSCT)
  • Actual Study Start Date: December 2016
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: June 2021
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: High Risk MDS
New diagnosed patients treated with Azacitidine 75 mg/sqm SC QD on a 28 days based cycles (both 7-0-0 and 5-0-2 regimens are allowed) until disease progression, unacceptable toxicity, death or investigator decision
Drug: Azacitidine Injection [Vidaza]
Outcome Measures
  • Primary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: 5- year overall survival ]
  • 2. Progression Free Survival (PFS) [ Time Frame: 5-year progression free survival ]
  • 3. Overall Response Rate (OOR) [ Time Frame: 12 months OOR ]
  • 4. Treatment-Emergent Adverse Events Rate (TEAE) [ Time Frame: 12 Months TEAE rate ]
  • Biospecimen Retention: Samples With DNA

    3 ml Bone Marrow Aspirate samples will be processed and stored at: Laboratorio de Hematología Primera Planta Edificio General ICO - Hospital Germans Trias i Pujol Ctra. Canyet s/n 08916 Badalona

Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Newly diagnosed High-Risk Myelodysplastic Syndrome
Criteria

Inclusion Criteria:

- Patients diagnosed with myelodysplastic syndrome (MDS) according to WHO criteria,
including non-proliferative chronic myelomonocytic leukemia (CMML) that is considered
high risk, and not candidates for transplantation.

- High-risk MDS: (following the Grupo Español Síndrome Mielodisplásico, GESDM MDS
guides) and the recommendations of Valcárcel, D. et al).

Median expected OS less than 30 months. Intermediate-2 or high risk IPSS and / or high or
very high risk WPSS and / or high or very high risk IPSSS-R.

IPSS of intermediate risk and / or WPSS of intermediate risk and / or IPSS-R of
intermediate risk that present at least one of the following characteristics:

Cytogenetic abnormality of the IPSS-R high or very high cytogenetic risk group Platelet
count <30 x10E9/l Neutrophil count 2 x upper limit of normal (ULN) Renal: Creatinine> 2 x upper limit of
normal (ULN)

- Ejection fraction (<40%) and / or symptomatic heart failure. - Leukaemia secondary to Myeloproliferative Syndrome. - Serious psychiatric or neurological disease. - Positive Serology for HIV. - Proliferative CMML

Contacts and Locations
Contacts

Contact: Joan Bargay, MD PhD 34 871 202158 jbargay@hsll.es

Contact: Lurdes Zamora, PhD +34 93 4978868 lzamora@iconcologia.net

Locations

Spain, Islas Baleares
Son Llàtzer
Palma

Sponsors and Collaborators

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

Hospital Son Llatzer

Germans Trias i Pujol Hospital

Celgene Corporation

Investigators

Principal Investigator: Joan Bargay, MD PhD Hospital Son Llatzer

Principal Investigator: Lurdes Zamora, PhD Germans Trias i Pujol Hospital

More Information