[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Groupe Francophone des Myelodysplasies\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":123},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,74,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100453222","phase-1-study-evaluating-combination-of-luspatercept-in-lr-mds-without-rs-having-failed-or-being-ineligible-to-esa-100453222",false,"NCT05181735","Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA","A Randomized Phase I\u002F II Multicenter Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA","Inclusion Criteria:\n\nPatients must meet all of the following criteria to participate in the study:\n\n* Myelodysplastic syndrome according to current WHO classification\n* Age ≥ 18 years\n* Patients with lower risk MDS according to IPSS classification (LOW, INT-1) without RS who failed to achieved a response or who subsequently relapse after ESA (at least 60000 U EPO-a over at least 12weeks or equivalent), without disease progression (or ineligible to ESA defined by EPO \\> 500 UI\u002Fl)\n* Hemoglobin \\\u003C 9 gr\u002Fdl or Transfusion dependant (at least 3 RBCs in 16 wk in at least 2 transfusion episodes)\n* Non del(5q) syndrome\n* Adequat renal function, defined by creatinine less than 1.5 times the upper limit of normal, creatinine clearance ≥ 40 mL\u002Fmin (MDRD formula).\n* Adequat liver function, defined by total bilirubin and transaminases less than 1.5 times the upper limit of normal.\n* Patient is not known to be refractory to platelet transfusions.\n* Written informed consent.\n* Patient must understand and voluntarily sign consent form.\n* Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements.\n* ECOG performance status 0-2 at the time of screening.\n* A FCBP (female of childbearing potential) for this study was defined as a sexually mature woman who: (1) had not undergone a hysterectomy or bilateral oophorectomy; or (2) had not been naturally postmenopausal (amenorrhea following cancer therapy did not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). A FCBP participating in the study must:\n\n  * Have had 2 negative pregnancy tests as verified by the investigator prior to starting IP (unless the screening pregnancy test was done within 72 hours of Cycle 1 Day 1). She must have had agreed to ongoing a monthly pregnancy testing during the course of the study and after EOT\n  * If sexually active, agreed to have used, and been able to comply with, highly effective contraception\\*\\* without interruption, 5 weeks prior to starting IP, during treatment with IP (including dose interruptions), and for 12 weeks after discontinuation of IP.\n  * \\*\\* Highly effective contraception was defined in this protocol as the following (information also appeared in the ICF): Hormonal contraception (eg, birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation (tying your tubes), or a partner with a vasectomy\n* Male subjects must: Have agreed to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (eg, polyurethane), during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions, and for at least 12 weeks following IP discontinuation, even if he had undergone a successful vasectomy\n\nExclusion Criteria:\n\nA patient meeting any of the following criteria is not eligible to participate in the study:\n\n* Severe infection or any other uncontrolled severe condition.\n* Uncontrolled hypertension\n* Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months.\n* del(5q) syndrome\n* Use of investigational agents within 30 days or any anticancer therapy (including IMiD) within 2 weeks before the study entry with the exception of hydroxyurea. The patient must have recovered at least a grade 1 from all acute toxicity from any previous therapy.\n* Use of EPO within 4 weeks before the study entry\n* Active cancer, or cancer during the year prior to trial entry other than basal cell carcinoma, or carcinoma in situ of the cervix or breast.\n* Patient already enrolled in another therapeutic trial of an investigational drug.\n* Known HIV infection or active hepatitis B or C.\n* Women who are or could become pregnant or who are currently breastfeeding.\n* Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form.\n* Patient eligible for allogeneic stem cell transplantation.\n* Known allergies to luspatercept or EPO or any of its excipients.\n* No affiliation to a health insurance system.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA",[27,28],"MDS","Myelodysplastic Syndromes",[27,30,31,32,33],"LR-MDS","Luspatercept","Eprex","ESA","RECRUITING","2026-03-03",{"date":37,"type":38},"2026-03-05","ACTUAL",{"date":40,"type":38},"2022-05-18",{"date":42,"type":20},"2029-06-19",{"name":44,"class":45},"Groupe Francophone des Myelodysplasies","OTHER",40,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100600549","phase-2-momelotinib-in-vexas-syndrome-100600549","NCT07098936","Momelotinib in VEXAS Syndrome","A Single-arm Phase II With safety-run-in Multicenter Study of Momelotinib in Patients With VEXAS Syndrome With or Without Associated Myelodysplastic Syndrome","Inclusion Criteria:\n\n* ECOG (Eastern Cooperative Oncology Group) performance status 0-2 at the time of screening\n* Age ≥ 18 years\n* Written informed consent\n* Diagnosis of VEXAS (Vacuoles, E1 enzyme, X-linked, Autoinflammatory and Somatic) syndrome with UBA1 (Ubiquitin Like Modifier Activating Enzyme 1) mutation and clinically symptomatic disease requiring immunosuppressive treatment and at least 10mg\u002Fd of glucocorticoids\n* Patients with uncontrolled symptoms related to VEXAS with prior treatment line(s) (including steroids)\n* Patients refractory\u002Fdependent to steroids\n* Single concomitant steroids therapy (e.g., prednisone or equivalent) at the time of inclusion is allowed\n* For patients treated with other immunosuppressive\u002Fimmunomodulatory therapy than glucocorticoids, a wash out period of 28 days is required prior momelotinib onset\n* Erythropoietin\u002Fluspatercept used as a growth factor treatment is not allowed 28 days prior enrollment\n* Adequate liver function (serum transaminases ≤ 3 x ULN (Upper Limits of Normal), Bilirubin ≤ 1.5 x ULN (isolated bilirubin \\> 1.5 x ULN is acceptable if bilirubin fractionated and direct bilirubin \\\u003C 35%)\n* Adequate renal function (creatinine clearance with MDRD (Modification of Diet in Renal Disease) formula \\> 30 ml\u002Fmin)\n* Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must:\n\n  1. Have a negative serum or urine pregnancy test within 24 hours prior to beginning treatment on this study. Lactating patients are excluded.\n  2. Agree to use, and to be able to comply with, effective contraception without interruption, 4 weeks before starting study drug throughout the entire duration study drug therapy (including doses interruptions) and for 12 weeks after the end of the study drug therapy.\n  3. Agree to learn about the procedures for preservation of egg before starting treatment.\n* Male patients must:\n\n  1. Agree the need for the use of a condom if engaged in sexual activity with a woman of childbearing potential during the entire period of treatment, even if disruption of treatment and during 12 weeks after end of treatment.\n  2. Agree to learn about the procedures for preservation of sperm before starting treatment.\n\nExclusion Criteria:\n\n* Patients with MDS (Myelodysplastic syndrome) scheduled for allogeneic stem cell transplant or high risk MDS according to IWG (International Working Group) 2023\n* Patients who are or have been already treated with Janus Kinase (JAK) inhibitors for VEXAS syndrome or another indication\n* Patients who are unable to receive a starting daily dose of momelotinib of at least 100 mg\n* Subjects with any other active malignancies are not eligible, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which subject has been disease-free for at least 3 years\n* Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 12 weeks prior to initiation of momelotinib\n* Known infection with acute and chronic active Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus\n* Any medical or psychiatric condition not allowing the informed consent of the subject\n* Presence of clinically meaningful active bacterial, fungal, parasitic or viral infection which requires therapy\n* Previous history of Progressive Multifocal Leuko-encephalopathy\n* Active gastrointestinal conditions that may affect absorption\n* No affiliation to a health insurance system\n* Known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients",{"count":55,"type":20},57,[24],"Multicenter, phase II trial with safety run-in to evaluate the efficacy and safety of momelotinib in patients with VEXAS (Vacuoles, E1 enzyme, X-linked, Autoinflammatory and Somatic) syndrome with or without associated myelodysplastic syndrome (MDS).\n\nThe study will consist of two consecutive steps, a dose-finding safety run-in and a single-arm prospective phase II.\n\nDuring safety run-in phase, three fixed dose levels will be tested according to a 3+3 design, using cohorts of size 3 in order to establish the maximum tolerated dose.\n\nAfter this safety run-in phase, patients included in phase II will be treated with momelotinib at the maximum tolerated dose preliminary fixed.\n\nPatients included in the phase II will receive momelotinib continuously until disease progression or loss of response, at physician's discretion.\n\nAll patients included in the study will receive glucocorticoids (prednisone\u002Fprednisolone equivalent) at baseline (at least \\> 10mg\u002Fday).\n\nResponse assessment regarding VEXAS related symptoms will be evaluated after 4, 12, 24 and 48 weeks. Response assessment regarding MDS features will be evaluated at 12 and 24 weeks.",[59,60],"VEXAS Syndome","Myelo Dysplastic Syndrome",[62,63,64],"VEXAS syndrome","Momelotinib","Myelodysplastic syndrome","2025-12-03",{"date":67,"type":38},"2025-12-10",{"date":69,"type":38},"2025-11-25",{"date":71,"type":20},"2028-11",{"name":44,"class":45},11,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100567594","phase-1-oral-arsenic-ato-in-low-risk-myelodysplastic-syndromes-mds-100567594","NCT06670222","Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS)","Phase I Study With Dose-escalation and Expansion Evaluating the Safety and Efficacy of Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes Failing Erythropoiesis Stimulating Agents and Luspatercept (or Ineligible for the Latter)","Inclusion criteria:\n\nPatients must meet all the following criteria to participate in the study:\n\n1. Myelodysplastic syndrome according to WHO (World Health Organization) 2022 classification\n2. Age ≥ 18 years\n3. Patient with low-risk Myelodysplastic Syndromes according to Revised International Prognostic Scoring System (IPSS-R) classification (very low, low, intermediate):\n\n   * non-sideroblastic who failed to achieved a response or who subsequently relapse after Erythropoiesis Stimulating Agents (ESA) (at Epoetin alfa 60000UI or equivalent over at least 12 weeks) without disease progression or ineligible to ESA (defined by Erythopoietine (EPO) \\> 500UI\u002FL)\n   * sideroblastic who failed to achieved a response or who subsequently relapse after ESA (at Epoetin alfa 60000UI or equivalent over at least 12 weeks) or ineligible for ESA (defined by EPO \\>500UI\u002FL) and who failed to achieved a response or who subsequently relapse after Luspatercept\n   * del (5q) who failed to achieved a response or who subsequently relapse after ESA (at Epoetin alfa 60000IU or equivalent over at least 12 weeks) and who failed to achieved a response or who subsequently relapse after Lenalidomide\n4. Transfusion dependence (at least 3 RBC (Red Blood Cell) within a 16-week period and at least 2 transfusion episodes during this period)\n5. Patient not eligible for another clinical trial\n6. Adequate renal function defined by creatinine level less than 1.5 times the upper limit of normal and creatinine clearance ≥ 40mL\u002Fmin (according to MDRD (Modification of Diet in Renal Disease) formula)\n7. Adequate liver function defined by total bilirubin and transaminases less than 1.5 times the upper limit of normal\n8. Patient not refractory to platelet transfusions\n9. Written consent\n10. Patient must understand and voluntarily sign informed consent form\n11. Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements\n12. Performance status 0-2 at the time of screening\n13. A FCBP (female of childbearing potential) for this study was defined as a sexually mature woman who: (1) had not undergone a hysterectomy or bilateral oophorectomy; or (2) had not been naturally postmenopausal (amenorrhea following cancer therapy did not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).\n\n    A FCBP participating in the study must:\n    * Have had 2 negative pregnancy tests as verified by the investigator prior to starting IP (unless the screening pregnancy test was done within 72 hours of Cycle 1 Day 1). She must have had agreed to ongoing a monthly pregnancy testing during the course of the study and after end of treatment.\n    * If sexually active, agreed to have used, and been able to comply with, highly effective contraception\\*\\* without interruption, 5 weeks prior to starting treatment, during treatment (including dose interruptions), and for 24 weeks after discontinuation of treatment.\n\n      * Highly effective contraception was defined in this protocol as the following (information also appeared in the Informed Consent Form): Hormonal contraception (eg, birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation (tying your tubes), or a partner with a vasectomy.\n14. Male subjects must: Have agreed to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (eg, polyurethane), during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions, and for at least 24 weeks following treatment discontinuation, even if he had undergone a successful vasectomy.\n\nExclusion criteria:\n\nAny patient meeting one of the following criteria cannot be included in the study:\n\n1. Severe infection or any uncontrolled severe condition\n2. Uncontrolled hypertension\n3. Significant cardiac disease - NYHA (New York Heart Association) Class III or IV or having suffered a myocardial infarction in the last 6 months\n4. QTcF (Fridericia's corrected QT interval) \\> 460ms\n5. Use of investigational agents within 30 days or any anticancer therapy (including IMiD (Immunomodulatory treatments)) within 2 weeks before the study entry with the exception of hydroxyurea. The patient must have recovered at least a grade 1 from all acute toxicity from any previous therapy. However, patients may have received Lenalidomide, hypomethylating agent, or anti-lymphocytic serum (ALS) (but not within 4 weeks before the study entry and, for ALS, within 16 weeks before the study entry).\n6. Use of EPO within 4 weeks before the study entry\n7. Active cancer or cancer during the year prior to trial entry other than basal cell carcinoma, or carcinoma in situ of the cervix or breast\n8. Patient already enrolled in another therapeutic trial of an investigational drug\n9. Known Human Immunodeficiency Virus infection or active hepatitis B or C\n10. Women who are or could become pregnant or who are currently breastfeeding\n11. Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form\n12. Patient eligible for allogeneic stem cell transplantation\n13. No affiliation to a health insurance system",{"count":82,"type":20},24,[23],"Phase I study with dose-escalation and expansion evaluating the safety and efficacy of oral Arsenic (ATO) in low-risk Myelodysplastic Syndromes having failed to Erythropoiesis Stimulating Agents and Luspatercept (or ineligible for the latter).",[86],"Low-risk Myelodysplastic Syndromes",[88,89],"Oral Arsenic","Low-risk myelodysplastic syndromes","2025-07-29",{"date":92,"type":38},"2025-07-31",{"date":94,"type":38},"2025-07-22",{"date":96,"type":20},"2027-07",{"name":44,"class":45},3,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":107,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100589618","registry-of-myelodysplastic-syndromes-and-therapy-related-acute-myeloid-leukemia-100589618","NCT06956755","Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Male or female\n* Age \\> 18 years\n* Patients with myelodysplastic syndrome and therapy-related acute myeloid leukemia\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Patient is unwilling or unable to give consent",{"count":106,"type":20},6990,"6 Months","OBSERVATIONAL","The Registry MDS is an ongoing, observational study that has collected longitudinal data on diagnostics, demographics, clinical parameters, and health Care Interventions (HCI) from patients with MDS and therapy-related acute myeloid leukemia",[28,111],"Leukemia, Myeloid, Acute",[27,113],"t-AML","2025-05-02",{"date":116,"type":38},"2025-05-06",{"date":118,"type":38},"2003-07-07",{"date":120,"type":20},"2031-01-05",{"name":44,"class":45},1,""]