Myelodysplastic SyndromesNCT04602273
Treatment of High Risk Myelodysplastic Syndromes (MDS) Not Candidates for Allogeneic Transplantation of Hematopoietic Progenitors (ALO-HSCT)
An observational study of Myelodysplastic Syndromes, run by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias at 1 site in Spain.
Trial summary
An observational, non-interventional, prospective and multicenter study of Azacitidine in newly diagnosed High Risk Myelodysplastic Syndromes. Primary objectives are to asses mutational status of target genes by Next Generation Sequencing, to evaluate prognostic value of geriatric assessment scales and to evaluate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Azacitidine Injection [Vidaza]
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2016to 30 Jun 2021
- Phase
- Observational
- 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
Study population: Newly diagnosed High-Risk Myelodysplastic Syndrome
Who may be able to join
- Patients diagnosed with myelodysplastic syndrome (MDS) according to WHO criteria, including non-proliferative chronic myelomonocytic leukemia (CMML) that is considered high risk, and not candidates for transplantation.
- High-risk MDS: (following the Grupo Español Síndrome Mielodisplásico, GESDM MDS guides) and the recommendations of Valcárcel, D. et al).
- Median expected OS less than 30 months. Intermediate-2 or high risk IPSS and / or high or very high risk WPSS and / or high or very high risk IPSSS-R.
- IPSS of intermediate risk and / or WPSS of intermediate risk and / or IPSS-R of intermediate risk that present at least one of the following characteristics:
- Cytogenetic abnormality of the IPSS-R high or very high cytogenetic risk group Platelet count <30 x10E9/l Neutrophil count <0.5 x 10E9 / l Presence of dense and diffuse myelofibrosis, with or without collagen formation (grades 2-3 of the European consensus) Category 3 of the LRSS score (MD Anderson low risk score system)
- Patient diagnosed with LAM de novo according to WHO criteria, with 20-30% blasts count in bone marrow, trilineal dysplasia and more than 70 years and not candidate for intensive chemotherapy.
- Willing to provide voluntary written informed consent
Who cannot join
- Serious active medical condition, not related to MDS, that could limit patient compliance and follow-up or that, in the Investigator's opinion,could compromise the patient's safety.
- Presence of other active malignant disease
- Organic function parameters: (except when the alteration is due to MDS) Hepatic: Bilirubin> 2 x upper limit of normal (ULN) Renal: Creatinine> 2 x upper limit of normal (ULN)
- Ejection fraction (<40%) and / or symptomatic heart failure.
- Leukaemia secondary to Myeloproliferative Syndrome.
- Serious psychiatric or neurological disease.
- Positive Serology for HIV.
- Proliferative CMML
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Son Llàtzer
Palma, Balearic Islands, 07198
Jose Borras, Bsc, 34 871202158, jborras@hsll.es
Joan Bargay, MD PhD
About this study
An observational, non-interventional, prospective and multicenter study of Azacitidine in newly diagnosed High Risk Myelodysplastic Syndromes.
Primary objectives are to asses mutational status of target genes by Next Generation Sequencing, to evaluate prognostic value of geriatric assessment scales and to evaluate overall survival.
Read more
The main hypothesis is that mutation status of target genes and geriatric scales have statistical significant impact on overall survival.
Study time points will be at diagnosis, 6, 12, 18 and 24 months, always taking into account the routine clinical practice, when sample to assess mutational status will be collected. Geriatric assessment will only be performed at diagnosis.
Upon the signature of informed consent and the checking of inclusion criteria, patients will receive treatment with Azacitidine 75 mg/sqm on a 28 days based cycles (both 7-0-0 and 5-0-2 regimens are allowed) until disease progression, unacceptable toxicity or investigator decision.
150 patients are expected to be recruited at study sites.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Azacitidine Injection [Vidaza]
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine Injection [Vidaza]Drug
| Study group | Role | What they receive |
|---|---|---|
| High Risk MDS | New diagnosed patients treated with Azacitidine 75 mg/sqm SC QD on a 28 days based cycles (both 7-0-0 and 5-0-2 regimens are allowed) until disease progression, unacceptable toxicity, death or investigator decision Receives: Drug: Azacitidine Injection [Vidaza] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: 5- year overall survival
Progression Free Survival (PFS)
Measured: 5-year progression free survival
Overall Response Rate (OOR)
Measured: 12 months OOR
Treatment-Emergent Adverse Events Rate (TEAE)
Measured: 12 Months TEAE rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start12 Dec 2016
- Primary completion1 Nov 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Son Llatzer, Germans Trias i Pujol Hospital, Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Joan Bargay, MD PhD, Principal investigator, Hospital Son LlatzerLurdes Zamora, PhD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602273
- Sponsor's protocol ID
- CET-AZA-2016-01
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: There is not a confirmed IPD sharing plan. It will be confirmed by Principal Investigators
Publications
Tefferi A, Vardiman JW. Myelodysplastic syndromes. N Engl J Med. 2009 Nov 5;361(19):1872-85. doi: 10.1056/NEJMra0902908. No abstract available.
PubMed 19890130Germing U, Strupp C, Kundgen A, Bowen D, Aul C, Haas R, Gattermann N. No increase in age-specific incidence of myelodysplastic syndromes. Haematologica. 2004 Aug;89(8):905-10.
PubMed 15339672Cazzola M, Malcovati L. Myelodysplastic syndromes--coping with ineffective hematopoiesis. N Engl J Med. 2005 Feb 10;352(6):536-8. doi: 10.1056/NEJMp048266. No abstract available.
PubMed 15703418Vardiman JW, Thiele J, Arber DA, Brunning RD, Borowitz MJ, Porwit A, Harris NL, Le Beau MM, Hellstrom-Lindberg E, Tefferi A, Bloomfield CD. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood. 2009 Jul 30;114(5):937-51. doi: 10.1182/blood-2009-03-209262. Epub 2009 Apr 8.
PubMed 19357394Greenberg PL, Tuechler H, Schanz J, Sanz G, Garcia-Manero G, Sole F, Bennett JM, Bowen D, Fenaux P, Dreyfus F, Kantarjian H, Kuendgen A, Levis A, Malcovati L, Cazzola M, Cermak J, Fonatsch C, Le Beau MM, Slovak ML, Krieger O, Luebbert M, Maciejewski J, Magalhaes SM, Miyazaki Y, Pfeilstocker M, Sekeres M, Sperr WR, Stauder R, Tauro S, Valent P, Vallespi T, van de Loosdrecht AA, Germing U, Haase D. Revised international prognostic scoring system for myelodysplastic syndromes. Blood. 2012 Sep 20;120(12):2454-65. doi: 10.1182/blood-2012-03-420489. Epub 2012 Jun 27.
PubMed 22740453Fega KR, Abel GA, Motyckova G, Sherman AE, DeAngelo DJ, Steensma DP, Galinsky I, Wadleigh M, Stone RM, Driver JA. Non-hematologic predictors of mortality improve the prognostic value of the international prognostic scoring system for MDS in older adults. J Geriatr Oncol. 2015 Jul;6(4):288-98. doi: 10.1016/j.jgo.2015.05.003. Epub 2015 Jun 11.
PubMed 26073533Hamaker ME, Mitrovic M, Stauder R. The G8 screening tool detects relevant geriatric impairments and predicts survival in elderly patients with a haematological malignancy. Ann Hematol. 2014 Jun;93(6):1031-40. doi: 10.1007/s00277-013-2001-0. Epub 2014 Feb 2.
PubMed 24488257Bonanad S, De la Rubia J, Gironella M, Perez Persona E, Gonzalez B, Fernandez Lago C, Arnan M, Zudaire M, Hernandez Rivas JA, Soler A, Marrero C, Olivier C, Altes A, Valcarcel D, Hernandez MT, Oiartzabal I, Fernandez Ordono R, Arnao M, Esquerra A, Sarra J, Gonzalez-Barca E, Gonzalez J, Calvo X, Nomdedeu M, Garcia Guinon A, Ramirez Payer A, Casado A, Lopez S, Duran M, Marcos M, Cruz-Jentoft AJ; GAH Group. Development and psychometric validation of a brief comprehensive health status assessment scale in older patients with hematological malignancies: The GAH Scale. J Geriatr Oncol. 2015 Sep;6(5):353-61. doi: 10.1016/j.jgo.2015.03.003. Epub 2015 Jun 29.
PubMed 26139300Rollison DE, Howlader N, Smith MT, Strom SS, Merritt WD, Ries LA, Edwards BK, List AF. Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood. 2008 Jul 1;112(1):45-52. doi: 10.1182/blood-2008-01-134858. Epub 2008 Apr 28.
PubMed 18443215Klepin HD. Myelodysplastic Syndromes and Acute Myeloid Leukemia in the Elderly. Clin Geriatr Med. 2016 Feb;32(1):155-73. doi: 10.1016/j.cger.2015.08.010.
PubMed 26614866Xicoy B, Jimenez MJ, Garcia O, Bargay J, Martinez-Robles V, Brunet S, Arilla MJ, Perez de Oteyza J, Andreu R, Casano FJ, Cervero CJ, Bailen A, Diez M, Gonzalez B, Vicente AI, Pedro C, Bernal T, Luno E, Cedena MT, Palomera L, Simiele A, Calvo JM, Marco V, Gomez E, Gomez M, Gallardo D, Munoz J, de Paz R, Grau J, Ribera JM, Benlloch LE, Sanz G. Results of treatment with azacitidine in patients aged >/= 75 years included in the Spanish Registry of Myelodysplastic Syndromes. Leuk Lymphoma. 2014 Jun;55(6):1300-3. doi: 10.3109/10428194.2013.834532. Epub 2013 Sep 16.
PubMed 23952246Gangat N, Patnaik MM, Tefferi A. Myelodysplastic syndromes: Contemporary review and how we treat. Am J Hematol. 2016 Jan;91(1):76-89. doi: 10.1002/ajh.24253.
PubMed 26769228Bejar R, Lord A, Stevenson K, Bar-Natan M, Perez-Ladaga A, Zaneveld J, Wang H, Caughey B, Stojanov P, Getz G, Garcia-Manero G, Kantarjian H, Chen R, Stone RM, Neuberg D, Steensma DP, Ebert BL. TET2 mutations predict response to hypomethylating agents in myelodysplastic syndrome patients. Blood. 2014 Oct 23;124(17):2705-12. doi: 10.1182/blood-2014-06-582809. Epub 2014 Sep 15.
PubMed 25224413Itzykson R, Kosmider O, Cluzeau T, Mansat-De Mas V, Dreyfus F, Beyne-Rauzy O, Quesnel B, Vey N, Gelsi-Boyer V, Raynaud S, Preudhomme C, Ades L, Fenaux P, Fontenay M; Groupe Francophone des Myelodysplasies (GFM). Impact of TET2 mutations on response rate to azacitidine in myelodysplastic syndromes and low blast count acute myeloid leukemias. Leukemia. 2011 Jul;25(7):1147-52. doi: 10.1038/leu.2011.71. Epub 2011 Apr 15.
PubMed 21494260Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Finelli C, Giagounidis A, Schoch R, Gattermann N, Sanz G, List A, Gore SD, Seymour JF, Bennett JM, Byrd J, Backstrom J, Zimmerman L, McKenzie D, Beach C, Silverman LR; International Vidaza High-Risk MDS Survival Study Group. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009 Mar;10(3):223-32. doi: 10.1016/S1470-2045(09)70003-8. Epub 2009 Feb 21.
PubMed 19230772
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of High Risk Myelodysplastic Syndromes (MDS) Not Candidates for Allogeneic Transplantation of Hematopoietic Progenitors (ALO-HSCT)
- ClinicalTrials.gov ID
- NCT04602273
- Acronym / sponsor ID
- CET-AZA-2016-01
- Conditions
- Myelodysplastic Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y MielodisplasiasUniversity, hospital or other
- Collaborators
- Hospital Son Llatzer, Germans Trias i Pujol Hospital, Celgene Corporation
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational, non-interventional, prospective and multicenter study of Azacitidine in newly diagnosed High Risk Myelodysplastic Syndromes.
Primary objectives are to asses mutational status of target genes by Next Generation Sequencing, to evaluate prognostic value of geriatric assessment scales and to evaluate overall survival.
The main hypothesis is that mutation status of target genes and geriatric scales have statistical significant impact on overall survival.
Study time points will be at diagnosis, 6, 12, 18 and 24 months, always taking into account the routine clinical practice, when sample to assess mutational status will be collected. Geriatric assessment will only be performed at diagnosis.
Upon the signature of informed consent and the checking of inclusion criteria, patients will receive treatment with Azacitidine 75 mg/sqm on a 28 days based cycles (both 7-0-0 and 5-0-2 regimens are allowed) until disease progression, unacceptable toxicity or investigator decision.
150 patients are expected to be recruited at study sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Risk MDS | – | Drug: Azacitidine Injection [Vidaza]New diagnosed patients treated with Azacitidine 75 mg/sqm SC QD on a 28 days based cycles (both 7-0-0 and 5-0-2 regimens are allowed) until disease progression, unacceptable toxicity, death or investigator decision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed High-Risk Myelodysplastic Syndrome
Key inclusion criteria (7 listed)
- Patients diagnosed with myelodysplastic syndrome (MDS) according to WHO criteria, including non-proliferative chronic myelomonocytic leukemia (CMML) that is considered high risk, and not candidates for transplantation.
- High-risk MDS: (following the Grupo Español Síndrome Mielodisplásico, GESDM MDS guides) and the recommendations of Valcárcel, D. et al).
- Median expected OS less than 30 months. Intermediate-2 or high risk IPSS and / or high or very high risk WPSS and / or high or very high risk IPSSS-R.
- IPSS of intermediate risk and / or WPSS of intermediate risk and / or IPSS-R of intermediate risk that present at least one of the following characteristics:
- Cytogenetic abnormality of the IPSS-R high or very high cytogenetic risk group Platelet count <30 x10E9/l Neutrophil count <0.5 x 10E9 / l Presence of dense and diffuse myelofibrosis, with or without collagen formation (grades 2-3 of the European consensus) Category 3 of the LRSS score (MD Anderson low risk score system)
Key exclusion criteria (8 listed)
- Serious active medical condition, not related to MDS, that could limit patient compliance and follow-up or that, in the Investigator's opinion,could compromise the patient's safety.
- Presence of other active malignant disease
- Organic function parameters: (except when the alteration is due to MDS) Hepatic: Bilirubin> 2 x upper limit of normal (ULN) Renal: Creatinine> 2 x upper limit of normal (ULN)
- Ejection fraction (<40%) and / or symptomatic heart failure.
- Leukaemia secondary to Myeloproliferative Syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azacitidine Injection [Vidaza] | Drug | High Risk MDS |
Primary outcome
Overall Survival (OS)
Time frame: 5- year overall survival
Progression Free Survival (PFS)
Time frame: 5-year progression free survival
Overall Response Rate (OOR)
Time frame: 12 months OOR
Treatment-Emergent Adverse Events Rate (TEAE)
Time frame: 12 Months TEAE rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Background: PubMed 19890130Tefferi A, Vardiman JW. Myelodysplastic syndromes. N Engl J Med. 2009 Nov 5;361(19):1872-85. doi: 10.1056/NEJMra0902908. No abstract available.
- Background: PubMed 15339672Germing U, Strupp C, Kundgen A, Bowen D, Aul C, Haas R, Gattermann N. No increase in age-specific incidence of myelodysplastic syndromes. Haematologica. 2004 Aug;89(8):905-10.
- Background: PubMed 15703418Cazzola M, Malcovati L. Myelodysplastic syndromes--coping with ineffective hematopoiesis. N Engl J Med. 2005 Feb 10;352(6):536-8. doi: 10.1056/NEJMp048266. No abstract available.
- Background: PubMed 19357394Vardiman JW, Thiele J, Arber DA, Brunning RD, Borowitz MJ, Porwit A, Harris NL, Le Beau MM, Hellstrom-Lindberg E, Tefferi A, Bloomfield CD. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood. 2009 Jul 30;114(5):937-51. doi: 10.1182/blood-2009-03-209262. Epub 2009 Apr 8.
- Background: PubMed 22740453Greenberg PL, Tuechler H, Schanz J, Sanz G, Garcia-Manero G, Sole F, Bennett JM, Bowen D, Fenaux P, Dreyfus F, Kantarjian H, Kuendgen A, Levis A, Malcovati L, Cazzola M, Cermak J, Fonatsch C, Le Beau MM, Slovak ML, Krieger O, Luebbert M, Maciejewski J, Magalhaes SM, Miyazaki Y, Pfeilstocker M, Sekeres M, Sperr WR, Stauder R, Tauro S, Valent P, Vallespi T, van de Loosdrecht AA, Germing U, Haase D. Revised international prognostic scoring system for myelodysplastic syndromes. Blood. 2012 Sep 20;120(12):2454-65. doi: 10.1182/blood-2012-03-420489. Epub 2012 Jun 27.
- Background: PubMed 26073533Fega KR, Abel GA, Motyckova G, Sherman AE, DeAngelo DJ, Steensma DP, Galinsky I, Wadleigh M, Stone RM, Driver JA. Non-hematologic predictors of mortality improve the prognostic value of the international prognostic scoring system for MDS in older adults. J Geriatr Oncol. 2015 Jul;6(4):288-98. doi: 10.1016/j.jgo.2015.05.003. Epub 2015 Jun 11.
- Background: PubMed 24488257Hamaker ME, Mitrovic M, Stauder R. The G8 screening tool detects relevant geriatric impairments and predicts survival in elderly patients with a haematological malignancy. Ann Hematol. 2014 Jun;93(6):1031-40. doi: 10.1007/s00277-013-2001-0. Epub 2014 Feb 2.
- Background: PubMed 26139300Bonanad S, De la Rubia J, Gironella M, Perez Persona E, Gonzalez B, Fernandez Lago C, Arnan M, Zudaire M, Hernandez Rivas JA, Soler A, Marrero C, Olivier C, Altes A, Valcarcel D, Hernandez MT, Oiartzabal I, Fernandez Ordono R, Arnao M, Esquerra A, Sarra J, Gonzalez-Barca E, Gonzalez J, Calvo X, Nomdedeu M, Garcia Guinon A, Ramirez Payer A, Casado A, Lopez S, Duran M, Marcos M, Cruz-Jentoft AJ; GAH Group. Development and psychometric validation of a brief comprehensive health status assessment scale in older patients with hematological malignancies: The GAH Scale. J Geriatr Oncol. 2015 Sep;6(5):353-61. doi: 10.1016/j.jgo.2015.03.003. Epub 2015 Jun 29.
- Background: PubMed 18443215Rollison DE, Howlader N, Smith MT, Strom SS, Merritt WD, Ries LA, Edwards BK, List AF. Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood. 2008 Jul 1;112(1):45-52. doi: 10.1182/blood-2008-01-134858. Epub 2008 Apr 28.
- Background: PubMed 26614866Klepin HD. Myelodysplastic Syndromes and Acute Myeloid Leukemia in the Elderly. Clin Geriatr Med. 2016 Feb;32(1):155-73. doi: 10.1016/j.cger.2015.08.010.
- Background: PubMed 23952246Xicoy B, Jimenez MJ, Garcia O, Bargay J, Martinez-Robles V, Brunet S, Arilla MJ, Perez de Oteyza J, Andreu R, Casano FJ, Cervero CJ, Bailen A, Diez M, Gonzalez B, Vicente AI, Pedro C, Bernal T, Luno E, Cedena MT, Palomera L, Simiele A, Calvo JM, Marco V, Gomez E, Gomez M, Gallardo D, Munoz J, de Paz R, Grau J, Ribera JM, Benlloch LE, Sanz G. Results of treatment with azacitidine in patients aged >/= 75 years included in the Spanish Registry of Myelodysplastic Syndromes. Leuk Lymphoma. 2014 Jun;55(6):1300-3. doi: 10.3109/10428194.2013.834532. Epub 2013 Sep 16.
- Background: PubMed 26769228Gangat N, Patnaik MM, Tefferi A. Myelodysplastic syndromes: Contemporary review and how we treat. Am J Hematol. 2016 Jan;91(1):76-89. doi: 10.1002/ajh.24253.
- Individual participant dataSharing planned: Undecided. There is not a confirmed IPD sharing plan. It will be confirmed by Principal Investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Bargay, MD PhD principal investigator
Hospital Son Llatzer
Lurdes Zamora, PhD principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes, run by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias at 1 site 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 8 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: status not confirmed, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joan Bargay, MD PhD (34 871 202158, jbargay@hsll.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 5- year overall survival). The study lists 4 primary outcomes in all. 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 NCT04602273, which also lists 17 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 26 Oct 2020.