AzTrials
AzTrials

Myelodysplastic SyndromePhase 2SIMIDISNCT00495547

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

A Phase 2 study testing Azacitidine and Beta Erythropoietin in people with Myelodysplastic Syndrome, run by PETHEMA Foundation at 10 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndrome
What is being tested?
Azacitidine and Beta Erythropoietin
How many people
16 participants
Where
10 sitesSpain
Study dates
Feb 2009to Jun 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Spain10 sites

  • Hospital Germans Trias i Pujol

    Badalona

  • Hospital Clínic Universitari

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Reina Sofía

    Córdoba

  • Hospital Virgen Blanca

    León

  • Hospital la Paz

    Madrid

  • Hospital Central de Asturias

    Oviedo

  • Hospital Son Llatzer

    Palma de Mallorca

  • Hospital Clinico Universitario

    Salamanca

  • Hospital La Fe de Valencia

    Valencia

Other trials in Spain

About this study

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.

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.

Read the 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.

Being tested
Azacitidine, Beta Erythropoietin
Keywords
Myelodysplastic Syndrome, Red Cell transfusion dependent
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzacitidineDrug

    Azacitidine

  • Beta ErythropoietinDrug

    Beta Erythropoietin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the efficacy of the treatment in response rate terms

    Measured: 6 months

Secondary outcomes (1)

  1. Evaluate the safety of the treatment

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2007 (estimated)
  2. Study startFeb 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00495547
Sponsor's protocol ID
2007-000972-18
Other IDs
SIMIDIS
Acronym
SIMIDIS
Status last verified
Apr 2014
First submitted
2 Jul 2007
Last updated
7 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Bennett JM, Catovsky D, Daniel MT, Flandrin G, Galton DA, Gralnick HR, Sultan C. Proposals for the classification of the myelodysplastic syndromes. Br J Haematol. 1982 Jun;51(2):189-99.

    PubMed 6952920

  • 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.

  • San Miguel JF, Sanz GF, Vallespi T, del Canizo MC, Sanz MA. Myelodysplastic syndromes. Crit Rev Oncol Hematol. 1996 May;23(1):57-93. doi: 10.1016/1040-8428(96)00197-7. No abstract available.

    PubMed 8817082

  • Sanz GF, Sanz MA, Vallespi T, Canizo MC, Torrabadella M, Garcia S, Irriguible D, San Miguel JF. Two regression models and a scoring system for predicting survival and planning treatment in myelodysplastic syndromes: a multivariate analysis of prognostic factors in 370 patients. Blood. 1989 Jul;74(1):395-408.

    PubMed 2752119

  • Aul C, Giagounidis A, Germing U. Epidemiological features of myelodysplastic syndromes: results from regional cancer surveys and hospital-based statistics. Int J Hematol. 2001 Jun;73(4):405-410. doi: 10.1007/BF02994001.

    PubMed 11503953

  • Sanz GF, Sanz MA, Greenberg PL. Prognostic factors and scoring systems in myelodysplastic syndromes. Haematologica. 1998 Apr;83(4):358-68.

    PubMed 9592987

  • Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88.

    PubMed 9058730

  • Alessandrino EP, Amadori S, Barosi G, Cazzola M, Grossi A, Liberato LN, Locatelli F, Marchetti M, Morra E, Rebulla P, Visani G, Tura S; Italian Society of Hematology. Evidence- and consensus-based practice guidelines for the therapy of primary myelodysplastic syndromes. A statement from the Italian Society of Hematology. Haematologica. 2002 Dec;87(12):1286-306.

    PubMed 12495903

  • Bowen D, Culligan D, Jowitt S, Kelsey S, Mufti G, Oscier D, Parker J; UK MDS Guidelines Group. Guidelines for the diagnosis and therapy of adult myelodysplastic syndromes. Br J Haematol. 2003 Jan;120(2):187-200. doi: 10.1046/j.1365-2141.2003.03907.x. No abstract available.

    PubMed 12542475

  • NCCN practice guidelines for the myelodysplastic syndromes. National Comprehensive Cancer Network. Oncology (Williston Park). 1998 Nov;12(11A):53-80. No abstract available.

    PubMed 10028503

  • Malcovati L, Porta MG, Pascutto C, Invernizzi R, Boni M, Travaglino E, Passamonti F, Arcaini L, Maffioli M, Bernasconi P, Lazzarino M, Cazzola M. Prognostic factors and life expectancy in myelodysplastic syndromes classified according to WHO criteria: a basis for clinical decision making. J Clin Oncol. 2005 Oct 20;23(30):7594-603. doi: 10.1200/JCO.2005.01.7038. Epub 2005 Sep 26.

    PubMed 16186598

  • Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, Lowenberg B, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Wijermans PW, Gore S, Greenberg PL; World Health Organization(WHO) international working group. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-4.

    PubMed 11090046

  • Cheson BD, Greenberg PL, Bennett JM, Lowenberg B, Wijermans PW, Nimer SD, Pinto A, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Gore SD, Schiffer CA, Kantarjian H. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood. 2006 Jul 15;108(2):419-25. doi: 10.1182/blood-2005-10-4149. Epub 2006 Apr 11.

    PubMed 16609072

  • Parker JE, Mufti GJ. The myelodysplastic syndromes: a matter of life or death. Acta Haematol. 2004;111(1-2):78-99. doi: 10.1159/000074488.

    PubMed 14646347

  • Tehranchi R, Fadeel B, Forsblom AM, Christensson B, Samuelsson J, Zhivotovsky B, Hellstrom-Lindberg E. Granulocyte colony-stimulating factor inhibits spontaneous cytochrome c release and mitochondria-dependent apoptosis of myelodysplastic syndrome hematopoietic progenitors. Blood. 2003 Feb 1;101(3):1080-6. doi: 10.1182/blood-2002-06-1774. Epub 2002 Sep 5.

    PubMed 12393561

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azacitidine and Beta Erythropoietin in people with Myelodysplastic Syndrome, run by PETHEMA Foundation at 10 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the efficacy of the treatment in response rate terms (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00495547, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in