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Completed

NCT Number: NCT01739452

Spanish Registry of Erythropoietic Stimulating Agents Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Grupo Español de Síndromes Mielodisplásicos

Other

Registry information

Official study 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.

Acronym: SPRESAS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 3, 2012
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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