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Clinical trials for 5q- syndrome

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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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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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    33 result(s) found for: 5q- syndrome. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2009-013619-36 Sponsor Protocol Number: SINTRA-REV Start Date*: 2009-11-02
    Sponsor Name:Fundación General de la Universidad de Salamanca
    Full Title: Estudio, multicéntrico, aleatorizado, doble ciego, fase III de Revlimid (Lenalidomida) versus placebo en pacientes con Síndrome Mielodisplasico de bajo riesgo (IPSS bajo e intermedio-1) con alterac...
    Medical condition: Pacientes mayores de 18 años con Síndrome Mielodisplasico de bajo riesgo (IPSS bajo e intermedio-1) con alteración en 5q- y anemia sin necesidades transfusionales
    Disease: Version SOC Term Classification Code Term Level
    12.0 10067096 5q minus myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Ongoing) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001639-21 Sponsor Protocol Number: NMDSG10B Start Date*: 2011-11-01
    Sponsor Name:NMDSG Nordics Myeloplastics Syndrom Study Group
    Full Title: A multicentre open randomized phase II study of the efficacy and safety of azacitidine alone or in combination with lenalidomide in high-risk myeloid disease (high-risk MDS and AML) with a karyotyp...
    Medical condition: Myelodysplastic syndrome and acute myeloid leukemia with a deletion of 5q
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067096 5q minus myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed) NO (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-005101-29 Sponsor Protocol Number: KCH-MDS-04-1.0 Start Date*: 2005-02-24
    Sponsor Name:King's College Hospital NHS Foundation Trust [...]
    1. King's College Hospital NHS Foundation Trust
    2. King's College London
    Full Title: THE EFFICACY AND SAFETY OF LENALIDOMIDE (Revlimid®) MONOTHERAPY IN RED BLOOD CELL TRANSFUSION DEPENDENT SUBJECTS WITH MYELODYSPLASTIC SYNDROME ASSOCIATED WITH A DEL (5q) CYTOGENETIC ABNORMALITY
    Medical condition: Myelodysplastic Syndrome (MDS) associated with a Del (5q) cytogenetic abnormality
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004864 10067097 5q minus MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-000327-10 Sponsor Protocol Number: SAMBA Start Date*: 2016-11-03
    Sponsor Name:GWT-TUD GmbH
    Full Title: SINGLE AGENT JNJ-56022473 IN MDS AND AML PATIENTS FAILING HYPOMETHYLATING AGENT BASED THERAPY
    Medical condition: AML and MDS patients failing or being refractory to hypomethylating agent (HMA) treatment.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000012984 10000886 Acute myeloid leukemia LLT
    20.0 100000074219 10067096 5q minus myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-003810-38 Sponsor Protocol Number: KCP-8602-801 Start Date*: 2021-12-01
    Sponsor Name:Karyopharm Therapeutics Inc.
    Full Title: Phase 1/2 Open-Label Study of the Safety, Tolerability and Efficacy of the Selective Inhibitor of Nuclear Export (SINE) Compound Eltanexor (KPT-8602) in Patients with Newly Diagnosed and Relapsed/R...
    Medical condition: High-risk primary refractory MDS patients
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028535 Myelodysplastic syndrome unclassifiable PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028534 Myelodysplastic syndrome NOS LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067096 5q minus myelodysplastic syndrome LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067387 Myelodysplastic syndrome transformation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-000362-53 Sponsor Protocol Number: QOLONERev2MDS Start Date*: 2016-11-23
    Sponsor Name:ASSOCIAZIONE QOL-ONE
    Full Title: Efficacy of eltrombopag plus lenalidomide combination therapy in patients with IPSS low and intermediate-risk myelodysplastic syndrome with isolated del5q: a multicenter, randomized, double-blind, ...
    Medical condition: Adult subject (18 years of age older) with low or intermediate-1 IPSS risk MDS with isolated del(5q)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004851 10028536 Myelodysplastic syndromes HLT
    19.0 100000004864 10067096 5q minus myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) GR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    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: 2007-000246-13 Sponsor Protocol Number: GFM-REV-2006-02 Start Date*: 2007-04-17
    Sponsor Name:Groupe Français des myélodysplasies
    Full Title: A phase II study of the efficacity and the safety of lenalidomide in subjects with intermediate or the high risk myelodysplastic syndromes (MSD) associated with a deletion (Del) 5q[31]
    Medical condition: Myelodysplastic syndrome (MDS) is a clonal disease of the bone marrow stem cells. The disease is frequent/asociated with cytopenia and/or blastosis. an evolution to an acute leukemia is not frequen...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-018270-20 Sponsor Protocol Number: ABRAZA Start Date*: 2010-08-23
    Sponsor Name:Asociación Andaluza de Hematología y Hemoterapia.
    Full Title: “Estudio, multicéntrico, aleatorizado, abierto, fase II de Vidaza (Azacitidina) versus tratamiento de soporte en pacientes con síndrome mielodisplásico de bajo riesgo (IPSS bajo e intermedio-1) sin...
    Medical condition: Síndrome Mielodisplásico (SMD) de bajo riesgo IPSS 0 int-1 con dependencia transfusional sin delección del cromosoma 5 (5q).
    Disease: Version SOC Term Classification Code Term Level
    11 10028536 Síndromes mielodisplásicos HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    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: 2009-011160-11 Sponsor Protocol Number: GFM-Aza-Rev-09 Start Date*: 2009-12-01
    Sponsor Name:Groupe Francophone des Myélodysplasies (GFM)
    Full Title: A phase II study of the efficacy and safety of lenalidomide combined to azacitidine in intermediate-2 or high risk MDS AND AML with del 5q
    Medical condition: Myelodysplastic Syndrome(MDS) / Acute Myeloid Leukemia(AML)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028533 Myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000812-41 Sponsor Protocol Number: GFM-EPO-PRETAR Start Date*: 2017-12-29
    Sponsor Name:GFM-Groupe Francophone des Myélodysplasies
    Full Title: A RANDOMIZED TRIAL TESTING EARLY VERSUS LATE ONSET OF EPO ALFA TREATMENT IN LOWER RISK MDS WITH NON RBC TRANSFUSION DEPENDENT ANEMIA AND WITHOUT DEL 5Q
    Medical condition: Adult subject (18 years of age older) with low or intermediate-1 IPSS risk MDS with transfusions independent anemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-000450-31 Sponsor Protocol Number: NMDSG07A Start Date*: 2007-06-20
    Sponsor Name:The Nordic MDS group
    Full Title: A multicentre phase II study of the efficacy and safety of lenalidomide in high-risk myeloid disease (high-risk MDS and AML) with a karyotype including del(5q) or monosomy 5.
    Medical condition: High risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid Leukemia with a karyotype including del(5q) or monosomy 5
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028533 Myelodysplastic syndrome LLT
    9.1 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-006032-36 Sponsor Protocol Number: GFM-chimio-Rev-08 Start Date*: 2008-12-11
    Sponsor Name:Groupe Francophone des Myélodysplasies (GFM)
    Full Title: A phase ii study of the efficacy and safety of lenalidomide combined to escalating doses of chemotherapy in intermediate-2-or high risk MDS and AML with del 5 q31
    Medical condition: Myelodysplastic Syndrome(MDS) / Acute Myeloid Leukemia(AML)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028533 Myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003669-21 Sponsor Protocol Number: CMBG453B12203 Start Date*: 2021-04-01
    Sponsor Name:Novartis Pharma AG
    Full Title: A single-arm, open-label, Phase II study of sabatolimab in combination with azacitidine and venetoclax in adult participants with high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R...
    Medical condition: high or very high risk MDS in adult patients
    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: HU (Prematurely Ended) DE (Prematurely Ended) BE (Prematurely Ended) GR (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-016522-14 Sponsor Protocol Number: 20090160 Start Date*: 2011-07-14
    Sponsor Name:Amgen Inc
    Full Title: A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin alfa for the Treatment of Anaemic Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
    Medical condition: Low or Intermediate-1 Risk 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: CZ (Completed) ES (Completed) BE (Completed) GR (Completed) DE (Completed) IT (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-006790-33 Sponsor Protocol Number: AMLU1 - RV-AML-PI-401 Start Date*: 2009-04-27
    Sponsor Name:AZIENDA OSPEDALIERA CARDARELLI
    Full Title: A Phase II Study of Low dose ARA-C + Lenalidomide for Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) without Deletion 5q in Patients Age 70 Years or Older Who Decline Remission Induction ...
    Medical condition: acute myeloid leukemia
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-008262-12 Sponsor Protocol Number: GFM-Len-Epo-08 Start Date*: 2009-10-05
    Sponsor Name:Groupe Francophone des Myélodysplasies
    Full Title: A phase II study evaluating the efficacy and safety of Lenalidomide (Revlimid®) with or without Epoetin beta (NeoRecormon®) in transfusion-dependent ESA-resistant patients with IPSS low- and interm...
    Medical condition: patients with IPSS low- and intermediate-1 risk myelodysplastic syndromes without chromosome 5 abnormality
    Disease: Version SOC Term Classification Code Term Level
    12.0 10028533 Myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-001853-89 Sponsor Protocol Number: CLI-043 Start Date*: 2006-07-07
    Sponsor Name:Vion Pharmaceuticals, Inc
    Full Title: A phase II study of Cloretazine for elderly patients with de novo poor risk acute myelogenous leukemia.
    Medical condition: Acute Myelogenous Leukemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004899-18 Sponsor Protocol Number: LUSPLUS Start Date*: 2021-09-17
    Sponsor Name:GWT-TUD GmbH
    Full Title: A phase IIIb, open-label, single arm study to evaluate the efficacy and safety of luspatercept in patients with lower-risk MDS and ring-sideroblastic phenotype (MDS-RS)
    Medical condition: Lower-risk myelodysplastic syndrome with ring-sideroblastic phenotype (MDS-RS)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028534 Myelodysplastic syndrome NOS LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068361 MDS LLT
    20.0 10005329 - Blood and lymphatic system disorders 10050910 Bone marrow disorder NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
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