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

This study has been terminated.
Sponsor:
Collaborators:
Roche Pharma AG
Celgene Corporation
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00495547
First received: July 2, 2007
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Myelodysplastic Syndrome
Drug: Azacitidine
Drug: Beta Erythropoietin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Evaluate the efficacy of the treatment in response rate terms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety of the treatment [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Azacitidine
    Azacitidine
    Drug: Beta Erythropoietin
    Beta Erythropoietin
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495547

Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Clínic Universitari
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.
3. San Miguel JF, Sanz GF, Vallespí T, Sanz MA. Myelodysplastic Syndromes. Crit Rev Oncol Hematol 1996; 23: 57-93
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
Study First Received: July 2, 2007
Last Updated: April 4, 2014
Health Authority: Spain: Ministry of Health

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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Epoetin Alfa
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on July 23, 2014