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Spanish Registry of Erythropoietic Stimulating Agents Study (SPRESAS)

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ClinicalTrials.gov Identifier: NCT01739452
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Síndromes Mielodisplásicos

Brief Summary:
Reviewing Spanish record of myelodysplastic syndromes (RESMD) data base in the group of patients with MDS. The information will be collected retrospectively from diagnosis of MDS, until the date of December 31, 2011.

Condition or disease
Myelodysplastic Syndrome

Detailed Description:
Review of RESMD data base in the group of patients with MDS from diagnosis of low risk myelodysplastic syndrome (MDS) and occurrence of anemia that began treatment with erythropoiesis stimulating agent (ESAs) / support transfusional before December 31, 2011. In all cases, data obtained will be prior to the date of the start of the study to ensure its retrospective nature, thus reflecting the routine use of erythropoietic agents in clinical and non-interference in the doctor's clinical practice.

Study Type : Observational
Actual Enrollment : 722 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: National Registry of Patients Diagnosed With Low-risk Myelodysplastic Syndromes According to the Criteria of the WHO / French-American-British Classification System (FAB) and IPSS and Treated With Erythropoietic Agents.
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Group/Cohort
erythropoiesis-stimulating agents
Patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1), treated with erythropoiesis-stimulating agents.
Transfusion support
A control group of patients who received only transfusional support.



Primary Outcome Measures :
  1. Collect and evaluate the Spanish experience of anemia treatment. [ Time Frame: 6 months ]
    Collect and evaluate retrospectively the Spanish experience of anemia treatment in patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1) evaluating the efficacy and safety of treatment with ESAs received for at least 24 weeks and the evolution of a control group of patients who received only transfusional support.


Secondary Outcome Measures :
  1. Duration of response [ Time Frame: 6 months ]
    In responders at week 24 of treatment, determine the duration of response after 48 weeks of treatment.

  2. Overall survival. [ Time Frame: 6 months ]
    Evaluate overall survival in the two groups of patients, support transfusional versus ESA.

  3. Adverse events [ Time Frame: 6 months ]
    Security: To determine the frequency, type, intensity and severity of adverse events and their possible relationship with the various ESA and progression to acute myelogenous leukemia.



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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
Patients diagnosed with MDS according to WHO classifications or FAB low-risk (IPSS low and intermediate-1) with anemia (Hb ≤ 11 g / dL) and treatment (support / ESA) started before December 31, 2011.
Criteria

Inclusion Criteria:

  • The patient has given consent to the collection of data in the RESMD.
  • Age ≥ 18 years.
  • Patient must be diagnosed with MDS according to WHO classifications or FAB low-risk (IPSS low and intermediate-1) with anemia (Hb ≤ 11 g / dL).
  • The patient has studies at the time of diagnosis discard the possibility that MDS anemia is due to deficiency of factors (iron, vitamin B12 or folic acid).
  • Initiation of treatment with ESAs or support transfusional at any spanish hematology service before December 31, 2011.

Exclusion Criteria:

  • Pretreatment of SMD with hypomethylating agents, lenalidomide, chemotherapy, other.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739452


Sponsors and Collaborators
Grupo Español de Síndromes Mielodisplásicos
Investigators
Study Chair: Maria Consuelo Cañizo, MD Hospital Universitario de Salamanca
Study Chair: María Díez, MD Hospital Universitario de Salamanca

Responsible Party: Grupo Español de Síndromes Mielodisplásicos
ClinicalTrials.gov Identifier: NCT01739452     History of Changes
Other Study ID Numbers: GESMD-SPRESAS-2012-01
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by Grupo Español de Síndromes Mielodisplásicos:
Low-risk MDS
myelodysplastic syndrome
retrospective

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Hematinics