Spanish Registry of Erythropoietic Stimulating Agents Study

Myelodysplastic Syndrome Clinical Trial

— SPRESAS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739452
• Other study ID #: GESMD-SPRESAS-2012-01
• Status: Completed
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Grupo Español de Síndromes Mielodisplásicos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Síndromes Mielodisplásicos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect and evaluate the Spanish experience of anemia treatment.	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.	6 months
Secondary	Duration of response	In responders at week 24 of treatment, determine the duration of response after 48 weeks of treatment.	6 months
Secondary	Overall survival.	Evaluate overall survival in the two groups of patients, support transfusional versus ESA.	6 months
Secondary	Adverse events	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.	6 months