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Clinical trials for MDS AND Anemia

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44396   clinical trials with a EudraCT protocol, of which   7408   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    73 result(s) found for: MDS AND Anemia. Displaying page 2 of 4.
    EudraCT Number: 2009-011513-24 Sponsor Protocol Number: CC-5013-MDS-005 Start Date*: 2009-12-14
    Sponsor Name:Celgene Corporation
    Full Title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) VERSUS PLACEBO IN SUBJECTS WITH TRANSFUSION...
    Medical condition: TRANSFUSION-DEPENDENT ANEMIA DUE TO IPSS LOW OR INTERMEDIATE-1 RISK MYELODYSPLASTIC SYNDROMES WITHOUT DELETION 5Q [31] AND UNRESPONSIVE OR REFRACTORY TO ERYTHROPOIESIS-STIMULATING AGENT
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) DE (Completed) FR (Completed) CZ (Completed) AT (Completed) IT (Completed) PT (Completed) GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2022-001253-23 Sponsor Protocol Number: 4202-ONC-203 Start Date*: 2022-09-23
    Sponsor Name:Forma Therapeutics, Inc.
    Full Title: A Phase 2 Open-Label Study to Evaluate Etavopivat for the Treatment of Anemia in Patients with Myelodysplastic Syndromes (MDS)
    Medical condition: Anemia of myelodysplastic syndromes (MDS), inherited hemolytic anemias, and other refractory anemias
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-003943-55 Sponsor Protocol Number: MDS0706 Start Date*: 2007-09-25
    Sponsor Name:AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
    Full Title: “Clinical and biological effects of 5-Azacitidine five days/monthly schedule in symptomatic low-risk myelodysplastic syndromes (MDSs)”
    Medical condition: Adlut patients with low risk MDS (IPPS 0-1)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10005329 Blood and lymphatic system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000783-14 Sponsor Protocol Number: SY-1425-201 Start Date*: 2017-10-27
    Sponsor Name:Syros Pharmaceuticals Inc.
    Full Title: A Biomarker-Directed Phase 2 Trial of SY-1425, a Selective Retinoic Acid Receptor Alpha Agonist, in Adult Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
    Medical condition: Acute Myeloid Leukemia (AML)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2009-011613-24 Sponsor Protocol Number: HOVON102AML/SAKK30/09 Start Date*: 2010-01-25
    Sponsor Name:HOVON Foundation
    Full Title: Randomized study with a run-in feasibility phase to assess the added value of Clofarabine in combination with standard remission-induction chemotherapy in patients aged 18-65 years with previously ...
    Medical condition: - a cytopathologically confirmed diagnosis of AML according WHO classification (excluding acute promyelocytic leukaemia) or - a diagnosis of refractory anemia with excess of blasts (RAEB) and ...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10054592 Refractory anemia with an excess of blasts LLT
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038270 Refractory anaemia with an excess of blasts PT
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066353 Treatment related acute myeloid leukemia LLT
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001223-31 Sponsor Protocol Number: KAISII Start Date*: 2016-10-11
    Sponsor Name:King's College Hospital NHS Foundation Trust
    Full Title: Incidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis
    Medical condition: Aplastic Anaemia, Myelodysplastic syndromes, Acute Myeloid Leukaemia undergoing immunosuppression therapy, high dose chemotherapy or reduced intensity stem cell transplantation
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038271 Refractory anaemia with excess blasts in transformation LLT
    19.0 10042613 - Surgical and medical procedures 10059041 Allogeneic peripheral haematopoietic stem cell transplant LLT
    19.0 10042613 - Surgical and medical procedures 10067862 Allogeneic stem cell transplantation LLT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038270 Refractory anaemia with an excess of blasts PT
    19.0 10005329 - Blood and lymphatic system disorders 10010776 Constitutional aplastic anaemia LLT
    19.0 10005329 - Blood and lymphatic system disorders 10068063 Aplastic anaemia relapse LLT
    19.0 10005329 - Blood and lymphatic system disorders 10036699 Primary idiopathic aplastic anaemia LLT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    19.0 10042613 - Surgical and medical procedures 10001756 Allogenic bone marrow transplantation therapy PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000884 Acute myeloid leukaemia NOS LLT
    19.0 10005329 - Blood and lymphatic system disorders 10032510 Other specified aplastic anaemias LLT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066355 Treatment related acute myeloid leukaemia LLT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060355 Acute myeloid leukaemia in remission LLT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028532 Myelodysplasia LLT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066764 Acute myeloid leukaemia progression LLT
    19.0 10005329 - Blood and lymphatic system disorders 10002967 Aplastic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002471-34 Sponsor Protocol Number: AZA-MDS-003 Start Date*: 2012-11-23
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red...
    Medical condition: Subjects with Red Blood Cell Transfusion-Dependent Anemia and Thrombocytopenia due to IPSS Lower-Risk Myelodysplastic Syndromes
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NO (Completed) SE (Completed) ES (Ongoing) CZ (Completed) PT (Completed) LT (Completed) IT (Completed) NL (Completed) GB (GB - no longer in EU/EEA) DE (Completed) FI (Completed) DK (Completed) FR (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2018-003395-12 Sponsor Protocol Number: ASTX727-02 Start Date*: 2019-11-14
    Sponsor Name:Astex Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) versus IV Decitabine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Mye...
    Medical condition: Acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009018 Chronic myelomonocytic leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) CZ (Completed) HU (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-000404-92 Sponsor Protocol Number: HOVON 92 AML Start Date*: 2008-09-12
    Sponsor Name:HOVON Foundation
    Full Title: Randomized study to assess the added value of Laromustine in combination with standard remission-induction chemotherapy in patients aged 18-65 years with previously untreated acute myeloid leukemia...
    Medical condition: AML according to WHO classification (excluding acute promyelocytic leukaemia) or refractory anemia with excess of blasts (RAEB) and IPSS score ≥1.5 or therapy-related AML/RAEB or biphenotypic le...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000886 Acute myeloid leukemia LLT
    9.1 10054593 Refractory anemia with excess blasts in transformation LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-002874-19 Sponsor Protocol Number: 63935937MDS3001 Start Date*: 2015-11-23
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Study to Evaluate Imetelstat (JNJ-63935937) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Sti...
    Medical condition: Myelodysplastic syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004851 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) CZ (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001876-75 Sponsor Protocol Number: HOVON103AMLSelinexor Start Date*: 2016-10-28
    Sponsor Name:HOVON Foundation
    Full Title: A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction chemotherapy in AML and high r...
    Medical condition: patients ≥ 66 years with: - a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antec...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10037803 RAEB LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001280-13 Sponsor Protocol Number: A536-05 Start Date*: 2014-09-03
    Sponsor Name:Acceleron Pharma Inc.
    Full Title: An Open-Label Extension Study to Evaluate the Long-Term Effects of ACE-536 for the Treatment of Anemia in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Previously Enrolle...
    Medical condition: Myelodysplastic Syndromes (MDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002212-26 Sponsor Protocol Number: MK-0683-065 Start Date*: 2007-09-19
    Sponsor Name:Groupe Francophone des Myélodysplasies
    Full Title: A Phase I/II Study of Vorinostat in Combination with Low Dose Ara-C for Patients with Intermediate-2 or High Risk Myelodysplastic Syndromes
    Medical condition: Patients with Intermediate-2 or High Risk Myelodysplastic Syndromes (MDS)as defined by the International Prognostic Scoring System (IPSS).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028532 Myelodysplasia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004811-31 Sponsor Protocol Number: GIMEMA MDS 0205 Start Date*: 2006-05-16
    Sponsor Name:G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO
    Full Title: An open label, phase II, non randomized, clinical trial of chemotherapy treatment with 5-Azacytidine plus valproic acid and eventually atra for patients diagnosed with Intermediate II and high risk...
    Medical condition: Intermediate II and high risk Myelodysplastic syndrome MDS
    Disease: Version SOC Term Classification Code Term Level
    8.1 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002915-93 Sponsor Protocol Number: ACE-536-LTFU-001 Start Date*: 2019-06-26
    Sponsor Name:Celgene Corporation
    Full Title: A phase 3B, open-label, single-arm, rollover study to evaluate long-term safety in subjects who have participated in other Luspatercept (ACE-536) clinical trials.
    Medical condition: Prior participation on a clinical trial of luspatercept (ACE-536) in protocols eligible for participation in this study ACE-536-LTFU-001 with the following medical conditions: - myelodysplastic syn...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10074356 Non-transfusion dependent thalassemia LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068361 MDS LLT
    20.1 100000004850 10054658 Thalassemia LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074689 Post polycythemia vera myelofibrosis LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074690 Post essential thrombocythemia myelofibrosis LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074691 Post polycythaemia vera myelofibrosis LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074692 Post essential thrombocythaemia myelofibrosis LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077161 Primary myelofibrosis PT
    20.0 100000004851 10002272 Anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) SE (Trial now transitioned) NL (Trial now transitioned) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) GR (Trial now transitioned) ES (Ongoing) BE (Completed) BG (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-000454-73 Sponsor Protocol Number: CC-5013-MDS-004 Start Date*: 2005-08-02
    Sponsor Name:Celgene Corporation
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, 3-ARM STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF LENALIDOMIDE VERSUS PLACEBO IN RED BLOOD CELL (RBC) TRANSFUSION-DEPENDENT SUBJECTS W...
    Medical condition: Transfusion-dependant, low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) DE (Completed) ES (Completed) IT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000205-22 Sponsor Protocol Number: CYAD-N2T-005 Start Date*: 2018-06-04
    Sponsor Name:Celyad Onclogy SA
    Full Title: An open-label, Phase I/II study to assess the safety and clinical activity of NKR-2 treatment administration after a non-myeloablative preconditioning chemotherapy in relapse/refractory acute myelo...
    Medical condition: NKR-2 has the potential to treat many distinct tumor-types. This trial will focus on Relapsed and/or refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-014455-68 Sponsor Protocol Number: HOVON103AMLTosedostat Start Date*: 2010-08-16
    Sponsor Name:HOVON Foundation
    Full Title: A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral tosedostat to standard induction therapy in AML and RAEB ≥ 66 years and ...
    Medical condition: patients ≥ 66 years.with a confirmed diagnosis of o AML (not APL) (see appendix A) or o refractory anemia with excess of blasts (RAEB) with an IPSS score ≥ 1.5 OR Patients of any age ≥ 1...
    Disease: Version SOC Term Classification Code Term Level
    15.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    15.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10037803 RAEB LLT
    15.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2015-003531-35 Sponsor Protocol Number: CICL670ARU01 Start Date*: 2016-03-07
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: 1 Year, Open-label Multicenter Evaluation of Efficacy, Safety of Deferasirox in Patients MDS, Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10054658 Thalassemia LLT
    19.0 100000004864 10028534 Myelodysplastic syndrome NOS LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-004287-26 Sponsor Protocol Number: 5F9009 Start Date*: 2021-05-19
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in Treatment-naïve Patients with Higher Risk Myelodysplas...
    Medical condition: Intermediate/high/very high risk myelodysplastic syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Prematurely Ended) BE (Completed) IE (Prematurely Ended) NL (Completed) AT (Prematurely Ended) DK (Prematurely Ended) PT (Prematurely Ended) NO (Prematurely Ended) FI (Completed) IT (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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