Clinical Trials Logo

Clinical Trial Summary

Study Objectives: To collect and describe demographics, disease-management, and treatment outcomes of Myelodysplastic Syndromes (MDS) patients who are newly diagnosed and classified according to the World Health Organization (WHO) criteria. To perform observational studies concerning relevant scientific research questions in MDS using clinical data and biological samples, and to present relevant research outcomes in the fields of diagnosis and prognostication, health related quality of life issues, health economics, and risk stratification for newly developed classes of drugs. To disseminate results of the studies to all stakeholders involved.


Clinical Trial Description

Methodology: Data on patients with MDS will be collected prospectively at diagnosis and at 6-months intervals after diagnosis. The data will be gathered by seventeen (or more) countries that are represented within the LeukemiaNet MDS Working Party and will be combined in one central European Database. Data analyses will be conducted by the Data Management Centre at the University of York in various sub studies, at specific time points as decided or requested by the steering committee, but at least once a year included in the European Registry and at the end of the follow-up period. Number of Patients & Centres Over 149 hematology centres in eighteen (or more) different countries (Austria, Croatia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, The Netherlands, Romania, Spain, Sweden, Switzerland and United Kingdom) will participate as referral centres in this Registry. The recruitment target is a minimum of 3000 cases lower-risk MDS and 1000 higher-risk cases. Population: The study population will consist of newly diagnosed patients with all subtypes of MDS classified according to the WHO criteria, including therapy-related MDS and MDS-F, AML with 20-<30 percent marrow blasts (former RAEB-t), and CMML and other forms of mixed MDS/MPD. Study Duration: The enrolment time is scheduled to continue until at least December 2022 but extension of the recruitment period is possible. Patients will be followed until withdrawal (for any reason) or termination of the EUMDS Registry. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00600860
Study type Observational
Source Radboud University
Contact Corine J van Marrewijk, PhD
Phone +31-24-3614794
Email corine.vanmarrewijk@radboudumc.nl
Status Recruiting
Phase
Start date April 2008
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT02550535 - A Phase I/II Study of Gene-modified WT1 TCR Therapy in MDS & AML Patients Phase 1/Phase 2
Completed NCT00186342 - Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies N/A
Completed NCT00528983 - Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myelogenous Leukemia Phase 1
Completed NCT01355913 - Screening and Genetic Monitoring of Patients With Myelodysplastic Syndromes (MDS) Under Different Treatment Modalities by Cytogenetic Analyses of Circulating CD34+Cells
Withdrawn NCT04985656 - A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes Phase 2
Completed NCT01736683 - Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML) Phase 2
Completed NCT02333058 - Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies Phase 2
Completed NCT01135849 - B-Receptor Signaling in Cardiomyopathy N/A
Withdrawn NCT04395092 - Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) Phase 2
Completed NCT01885897 - IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT Phase 1/Phase 2
Recruiting NCT05092451 - Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances Phase 1/Phase 2
Recruiting NCT05884333 - Cord Blood Transplant in Adults With Blood Cancers Phase 2
Completed NCT02390414 - The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study
Completed NCT01326377 - ON 01910.Na for Intermediate1-2, or High Risk Trisomy 8 Myelodysplastic Syndrome (MDS) Phase 2
Completed NCT02966782 - A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS) Phase 1
Recruiting NCT02779569 - A Clinical Trial Evaluating the Efficacy of Ultra Low Dose of Decitabine in Myelodysplastic Syndromes (MDS) N/A
Recruiting NCT02099669 - Red Blood Cell Transfusion Thresholds and QOL in MDS N/A
Completed NCT01392989 - Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders Phase 2
Not yet recruiting NCT06398457 - Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies Early Phase 1
Recruiting NCT02775383 - The National Myelodysplastic Syndromes (MDS) Study