Back to resultsSIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome (SIMIDIS)
Primary Purpose
Myelodysplastic Syndrome
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Azacitidine
Beta Erythropoietin
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Myelodysplastic Syndrome, Red Cell transfusion dependent
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital Germans Trias i Pujol
- Hospital Clínic Universitari
- Hospital del Mar
- Hospital Reina Sofía
- Hospital Virgen Blanca
- Hospital la Paz
- Hospital Central de Asturias
- Hospital Son Llatzer
- Hospital Clinico Universitario
- Hospital La Fe de Valencia
Outcomes
Primary Outcome Measures
Evaluate the efficacy of the treatment in response rate terms
Secondary Outcome Measures
Evaluate the safety of the treatment
Full Information
NCT ID
NCT00495547
First Posted
July 2, 2007
Last Updated
April 4, 2014
Sponsor
PETHEMA Foundation
Collaborators
Roche Pharma AG, Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00495547
Brief Title
SIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome
Acronym
SIMIDIS
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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PETHEMA Foundation
Collaborators
Roche Pharma AG, Celgene Corporation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Myelodysplastic Syndrome, Red Cell transfusion dependent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Azacitidine
Intervention Type
Drug
Intervention Name(s)
Beta Erythropoietin
Intervention Description
Beta Erythropoietin
Primary Outcome Measure Information:
Title
Evaluate the efficacy of the treatment in response rate terms
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluate the safety of the treatment
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanz Guillermo, Dr
Organizational Affiliation
Hospital La Fe
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Del Cañizo Consuelo, DR
Organizational Affiliation
Hospital Clinico de Salamanca
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Clínic Universitari
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Hospital Virgen Blanca
City
Leon
Country
Spain
Facility Name
Hospital la Paz
City
Madrid
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de mallorca
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Salamanca
Country
Spain
Facility Name
Hospital La Fe de Valencia
City
Valencia
Country
Spain
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Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology
Learn more about this trial
SIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome
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