SIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome

NCT00495547 | Terminated Phase 2 DMC

• 2 other identifiers: 2007-000972-18SIMIDIS
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 10

Brief Summary

The primary objective is to evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to evaluate the safety of the treatment.

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome; Red Cell transfusion dependent

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of the treatment in response rate terms

  6 months

Secondary Outcomes (1)

• Evaluate the safety of the treatment

  2 months

Interventions

Azacitidine DRUG

Azacitidine

Beta Erythropoietin DRUG

Beta Erythropoietin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must voluntary sign the informed consent.
• Age ≥ 18 years.
• Must be able to comply with the protocol requirements
• Patient recently diagnosed with Myelodysplastic syndrome red cell transfusion dependent with low or intermediate -1 risk according IPSS criteria.
• Red cell transfusion dependent anemia.
• El patient has to be able to complain with the protocol visits.
• Women and man must accept to use high efficacy anticonceptive methods

You may not qualify if:

• Pregnancy or breast-feed women.
• Patients previously received treatment with azacytidine .
• Patients previously received treatment with erythropoietin agents.
• Proliferative Chronic myelomonocytic Leukaemia (leukocytes ≥ 12000/mL).
• Patient with a previous clinical history of another cancer (except for basocellular carcinoma or spinocellular carcinoma in situ of cervix or breast) except if the patient is free of symptoms during ≥ 3 years.
• Cytotoxic chemotherapy or experimental agents usage for myelodysplastic syndrome treatment during 28 days.
• Previous haematopoietic transplant.
• Mielosupresion and antitumoral treatment during the previous 28 days.
• The following laboratory data:
• Absolute neutrophil count \< 1000 cel/ml (0.5x 109L) Platelet count \< 50000/μL (25 x 109/L) Creatinine \> 2.0 mg/dL (177 mmol/L) Aspartate transaminase (AST) or Alanine transaminase (ALT ) \> 5 x the upper limit of normal. Total bilirubin: \> 2 mg/dL
• Patients with B12 vitamin, folic acid and ferrum deficiency.
• Patient with positive VIH-1.
• Any other organic or mental illness that could make impossible to sign the Inform consent or involve risk to the patient.
• Patient has hypersensitivity previous to beta ,azacytidine, erythropoietin and/or mannitol.

Sponsors & Collaborators

• PETHEMA Foundation: lead
• Roche Pharma AG: collaborator
• Celgene Corporation: collaborator

Study Sites (10)

Hospital Germans Trias i Pujol

Badalona, Spain

Location

Hospital Clínic Universitari

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Reina Sofía

Córdoba, Spain

Location

Hospital Virgen Blanca

León, Spain

Location

Hospital la Paz

Madrid, Spain

Location

Hospital Central de Asturias

Oviedo, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Spain

Location

Hospital Clinico Universitario

Salamanca, Spain

Location

Hospital La Fe de Valencia

Valencia, Spain

Location

Related Publications (34)

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Related Links

• Spanish association of Haematology

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Sanz Guillermo, Dr

  Hospital La Fe

  STUDY DIRECTOR

• Del Cañizo Consuelo, DR

  Hospital Clinico de Salamanca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 3, 2007
• Study Start: February 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

ES (10)