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

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ClinicalTrials.gov Identifier: NCT00495547
Recruitment Status : Terminated
First Posted : July 3, 2007
Last Update Posted : April 7, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: Azacitidine Drug: Beta Erythropoietin Phase 2

Detailed Description:

A total of up to 30 patients diagnosed of myelodysplastic syndrome red cell transfusion dependent with low or intermediate -1 risk will be included.

The patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment, Treatment and Follow up.

The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility.

During Treatment Period patients will be evaluated once a month although biochemistry and haematology parameters will be evaluated every 2 weeks.

If an erythroid response after 24 weeks is determined, a extension treatment will be carry out without disease progression.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Non-Randomized, Open-Label Study to Evaluate Efficacy and Safety of Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome Red Cell Transfusion Dependent With Low or Intermediate -1 Risk.
Study Start Date : February 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Azacitidine
    Azacitidine
    Drug: Beta Erythropoietin
    Beta Erythropoietin

Outcome Measures

Primary Outcome Measures :
  1. Evaluate the efficacy of the treatment in response rate terms [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Evaluate the safety of the treatment [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnancy or breast-feed women.
  2. Patients previously received treatment with azacytidine .
  3. Patients previously received treatment with erythropoietin agents.
  4. Proliferative Chronic myelomonocytic Leukaemia (leukocytes ≥ 12000/mL).
  5. 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.
  6. Cytotoxic chemotherapy or experimental agents usage for myelodysplastic syndrome treatment during 28 days.
  7. Previous haematopoietic transplant.
  8. Mielosupresion and antitumoral treatment during the previous 28 days.
  9. 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

  10. Patients with B12 vitamin, folic acid and ferrum deficiency.
  11. Patient with positive VIH-1.
  12. Any other organic or mental illness that could make impossible to sign the Inform consent or involve risk to the patient.
  13. Patient has hypersensitivity previous to beta ,azacytidine, erythropoietin and/or mannitol.
Contacts and Locations

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): NCT00495547


Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Clínic Universitari
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Reina Sofía
Córdoba, Spain
Hospital Virgen Blanca
Leon, Spain
Hospital la Paz
Madrid, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Son Llatzer
Palma de mallorca, Spain
Hospital Clinico Universitario
Salamanca, Spain
Hospital La Fe de Valencia
Valencia, Spain
Sponsors and Collaborators
PETHEMA Foundation
Roche Pharma AG
Celgene Corporation
Investigators
Study Director: Sanz Guillermo, Dr Hospital La Fe
Study Director: Del Cañizo Consuelo, DR Hospital Clinico de Salamanca
More Information

Additional Information:
Publications:
2. Brunning RD, Head D, Bennett JM, Vardiman JW, Flandrin G, Harris NL et al. Myelodysplastic syndromes: introduction. En: Jaffe ES, Harris NL, Stein H, Vardiman JW, eds. Tumours of haematopoietic and lymphoid tissues. Lyon, IARC Press, 2001; 63-67.
33. Mundle S, Lefebvre P, Duh MS, et al. Erythroid response (ER) rates in myelodysplastic syndromes (MDS) patients treated with epoetin alfa (EPO) or darbepoetin alfa (DARB) using International Working Group response criteria (IWGc): Comparative meta-analysis. Blood 2006; 108; 2672 (abstr
34. Lyons RM, Cosgriff T, Modi S, et al. Hematologic improvement, transfusion independence, and safety assessed using three alternative dosing schedules of azacitidine in patients with myelodysplastic syndromes. Blood 2006; 108; 2662 (abstr).

Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00495547     History of Changes
Other Study ID Numbers: 2007-000972-18
SIMIDIS
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014

Keywords provided by PETHEMA Foundation:
Myelodysplastic Syndrome
Red Cell transfusion dependent

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Epoetin Alfa
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Hematinics