[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mdsmpn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mdsmpn":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100367219","phase-1-active-myeloid-target-compound-combinations-in-mdsmpn-overlap-syndromes-overlap-syndromes-abnl-marro-100367219",false,"NCT04061421","Active Myeloid Target Compound Combinations in MDS\u002FMPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)","The ABNL-MARRO 001 Study: A Phase 1\u002F2 Study of Active Myeloid Target Compound Combinations in MDS\u002FMPN Overlap Syndromes.","ABNL-MARRO","Inclusion Criteria:\n\n1. Must be ≥ 18 years of age at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF; and must be willing and able to meet all study requirements.\n2. Must have morphologically confirmed diagnosis of MDS\u002FMPN, excluding JMML, in accordance with WHO (2016) diagnostic criteria (Appendix 1, Section 12.1).\n3. Treatment-naïve patients (patients who have had no prior disease-modifying therapy) may enroll in any AM-001 Arm that is open to accrual in phase 1 or phase 2. Treatment-naïve patients may have received recombinant erythropoietin, danazol, hydroxyurea or anagrelide, which are not considered to be disease-modifying therapy for the purpose of this study.\n4. After an appropriate wash-out period, patients who have failed (or were intolerant to) prior therapy with a regimen(s) containing a DNMTi may enroll in any Arm in phase 1b or any Arm which has met the criterion of the first Simon's Stage and are open to accrual in the second Simon's Stage in phase 2 (Error! Reference source not found.). Except in the first stage of the phase 2, there are no limits on number of prior therapies if the patient meets all other eligibility criteria. Previously treated patients include:\n\n   * Patients treated with DNMTi therapy prior to enrollment in AM-001 who failed to achieve a complete remission, per the MDS\u002FMPN IWG response criteria, after at least 4 cycles of DNMTi therapy\n   * Patients enrolled in AM-001, or patients treated off-study with a regimen containing a DNMTi, who have definitive disease progression as defined in the protocol after at least 2 cycles of the prior therapy-this includes patients who fail to achieve a response with clearly progressive disease and patients who achieve an initial response who then lose that response;\n   * Patients enrolled in AM-001 who have stable disease as best response at the second response evaluation after 6 cycles of the prior AM-001 therapy;\n   * Patients treated on AM-001 who had and recovered from an adverse event that precludes further therapy on that Arm; after recovery from a toxicity that is likely to be related to ASTX727, enrollment in another AM-001 may occur provided that dose modifications are made as appropriate.\n5. Must be willing to undergo bone marrow biopsy with aspiration during screening and bone marrow aspiration with tissue collection for disease assessment and correlative studies periodically throughout the trial.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n7. Life expectancy of at least 3 months, as assessed by the treating physician.\n8. For previously treated patients, recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia.\n9. Must have adequate hepatic and renal function during screening as demonstrated by:\n\n   * ALT (SGPT) and AST (SGOT) ≤ 3x the institutional upper limit of normal (ULN);\n   * Total bilirubin ≤ 1.5x ULN or ≤ 2x ULN, if upon judgment of the treating investigator the elevated bilirubin is due to extramedullary hematopoiesis related to the underlying MDS\u002FMPN or to Gilbert's disease;\n   * Calculated creatinine clearance (CrCl) ≥60 mL\u002Fmin. For dose modification purposes in Arm B, CrCl should be calculated using the Cockcroft-Gault equation. For patients with renal impairment entering Arm B (ASTX727 + ruxolitinib), specific dose modifications per the section 6.5.4 will apply.\n\nExclusion Criteria:\n\n1. Patients should be excluded from any treatment Arm that includes a novel targeted agent to which they have had previous exposure. Novel targeted agents in this study currently include itacitinib (INCB039110) and ruxolitinib (RUX) only, currently. Patients who have had prior exposure to ASTX727 therapy are not excluded, provided they meet all other eligibility criteria.\n2. Prior receipt of any investigational study drug, including treatment on any prior AM-001 Arm, within 30 days or 5 half-lives (whichever is shorter) before receiving the first dose of study drug in an Arm of AM-001, except if approved by the medical monitor.\n3. Prior receipt of any systemic antineoplastic therapy, including but not limited to prior DNMTi therapy, standard induction or cytotoxic chemotherapy (excluding hydroxyurea), or approved targeted agent within 21 days or 5 half-lives (whichever is shorter) before receiving the first dose of study drug in an Arm of AM-001.\n4. Known hypersensitivity to decitabine and ruxolitinib.\n5. Transformation to acute myeloid leukemia (e.g., \\>20% myeloid blasts in bone marrow or \\>20% circulating blasts in peripheral blood).\n6. Organ transplant recipients including allogeneic hematopoietic stem cell transplant.\n7. History of clinically significant or uncontrolled cardiac disease, including recent history (within 6 months) of unstable angina, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure, or clinically significant uncontrolled arrhythmia. Patients with history of atrial tachycardia and\u002For bradycardia that is well-controlled with medical management and\u002For pacemaker for at least 1 month before the first dose of study drug will be allowed.\n8. History of thromboemobolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infraction) in the 6 months prior to study entry.\n9. Active HBV or HCV. Participants with positive total HBc antibody or positive HCV antibody must have negative viral load for HBV and HCV at screening.\n10. Known HIV seropositive status. For participants with unknown HIV status, HIV testing will be performed at screening.\n11. History of abnormal electrocardiogram (ECG) or presence of abnormal screening ECG that, in the investigator's opinion, is clinically significant and contraindicated for clinical study. Corrected QT interval (QTc), as corrected by Fredericia, on screening ECG \\>500 milliseconds is excluded, unless there is concomitant right bundle branch block (RBBB) or concomitant left bundle branch block (LBBB) with a pacemaker.\n12. Any known contraindications to the use of ASTX727.\n13. Any sign of active and clinically significant bleeding.\n14. Other active malignancy, not including localized non-melanoma skin cancer, cervical carcinoma in situ, breast ductal carcinoma in situ of the breast, or localized prostate cancer controlled with hormone therapy. Patients with history of other cancers should be free of disease without ongoing anti-neoplastic therapy for at least 2 years.\n15. Receipt of wide-field radiotherapy (including therapeutic radioisotopes) ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study medications; or has not recovered from side effects of such therapy.\n16. Patients who require continuation of a prohibited concomitant medication (Section 6.6) for which no alternative therapy or allowable substitute is available.\n17. Active, uncontrolled infection. Patients with infection that is under control with active treatment are eligible.\n18. Major surgery requiring general anesthesia within 4 weeks prior to starting study treatment. (Placement of a central line or port-a-catheter is acceptable within this time frame and does not exclude the patient.)\n19. Women who are pregnant or lactating.\n20. Subjects who expect to conceive or father children within the projected duration of the study and\u002For who are unwilling to use highly effective methods of contraception throughout the duration of the study, starting with the screening visit through the end of treatment visit. For women of child-bearing potential (WOCBP), a negative urine pregnancy test at screening and immediately prior to initiating treatment on any AM-001 treatment Arm (Cycle 1 Day 1) is required.\n21. Any concurrent serious or unstable medical or psychiatric condition that in the investigator's opinion would jeopardize the patient's ability to provide informed consent or to comply with the protocol.\n22. Any psychological, familial, geographical or sociological condition that in the investigator's opinion would jeopardize the patient's ability to comply with the protocol.","ALL","18 Years",{"count":20,"type":21},94,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","ABNL-MARRO (A Basket study of Novel therapy for untreated MDS\u002FMPN and Relapsed\u002FRefractory Overlap Syndromes) is an international European-American cooperation providing the framework for collaborative studies to advance treatment of myelodysplastic\u002Fmyeloproliferative neoplasms (MDS\u002FMPN) and explore clinical-pathologic markers of disease severity, prognosis and treatment response.\n\nABNL MARRO 001 (AM-001) is an Open label, phase 1\u002F2 study within the framework of the ABNL-MARRO that will test novel treatment combinations in MDS\u002FMPN. Each Arm of AM-001 will test an active myeloid target compound in combination with ASTX727, an oral drug combining fixed doses of the DNA methyltransferase inhibitor (DNMTi) decitabine and the cytidine deaminase inhibitor E7727, also known as cedazuridine in a single tablet.",[28],"MDS\u002FMPN","RECRUITING","2026-04-15",{"date":32,"type":33},"2026-04-21","ACTUAL",{"date":35,"type":33},"2021-11-24",{"date":37,"type":21},"2027-12",{"name":39,"class":40},"Michael Savona","OTHER",4,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100532312","assessment-of-measurable-residual-disease-in-allo-hsct-using-digital-polymerase-chain-reaction-100532312","NCT06211166","Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction","Predicting Patient Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: A Comparison of Measurable Residual Disease (MRD) Assessment by Digital Polymerase Chain Reaction and Conventional MRD","Inclusion Criteria:\n\n* The presence of at least one fusion gene or hematological tumor-associated mutation detected at diagnosis by NGS or real-time PCR provided for posttransplant MRD monitoring.\n* Neutrophil engraftment\n* Received at least one MRD monitoring by digital PCR after HSCT\n\nExclusion Criteria:\n\n* Patients who relapsed or died before the first digital PCR monitoring\n* Patients only with mutations in DNMT3A, TET2, and ASXL1 (\"DTA mutations\") or only germline mutations",{"count":50,"type":21},300,"OBSERVATIONAL","A research investigation into the efficacy of digital Polymerase Chain Reaction (dPCR) for monitoring measurable residual disease (MRD) during allogeneic hematopoietic stem cell transplantation, with a focus on predicting relapse in patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions.",[54,55,28,56],"Acute Leukemia","MDS","CML",[58,59,60,61],"dPCR","MRD","allo-HSCT","leukemia","2024-01-08",{"date":64,"type":33},"2024-01-18",{"date":62,"type":33},{"date":67,"type":21},"2027-12-31",{"name":69,"class":40},"Peking University People's Hospital",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":70},"100502107","phase-2-clinical-study-of-azacitidine-combined-with-ruxolitinib-in-the-treatment-of-higher-risk-mdsmpn-100502107","NCT05817955","Clinical Study of Azacitidine Combined With Ruxolitinib in the Treatment of Higher-risk MDS\u002FMPN","Clinical Study of Azacitidine Combined With Ruxolitinib in the Treatment of Higher-risk Myelodysplastic Syndromes∕Myeloproliferative Neoplasms","Inclusion Criteria:\n\n• According to WHO (2016) classification, researchers made the diagnosis of CMML based on clinical and morphological characteristics. Other criteria should be met: 1) Neut ≥2x109\u002FL, PLT ≥25x109\u002FL, 2) belongs to the following prognostic risk group according to CPSS-MOL or MMM : CPSS-MOL: inter-2 risk (2 to 3 points); high risk (≥4 points);\n\nMMM: inter-2 risk (2.5 to 4.5 points); high risk (≥5 points), or:\n\n* According to the WHO (2016) classification standards (Arber 2016), researchers made the diagnosis of other types of MDS\u002FMPN (including aCML and MDS \u002FMPN-U) based on clinical and morphological characteristics. Other criteria should be met: 1) Neut ≥2x109\u002FL, PLT ≥25x109\u002FL, 2) Bone marrow blasts ≥5%;\n* Patients who are not suitable for hematopoietic stem cell transplantation (HSCT) according to the local medical standards and treatment guidelines;\n* Patients who are suitable for Azacitidine(AZA) treatment according to the local medical standards and treatment guidelines;\n* BCR-ABL positive Chronic Myelogenous Leukemia (CML) and Ph chromosomal negative classic myeloproliferative Neoplasms, such as essential thrombocytosis (ET), polycythemia vera (PV) and primary myelofibrosis (PMF) are excluded;\n* Age is between 18 to 80 years old;\n* ALT, AST and serum bilirubin is no more than 2 times of the upper limit of normal values (ULN), serum creatinine is no more than 150 μmol\u002FL, and serum myocardial enzyme is less than (the same age) 2 times of normal value upper limit;\n* The LVEF determined by the echocardiography is no less than 50%;\n* Estimated glomerular filtration rate (EGFR) is no less than 30ml · min · 1.73m2;\n* Eastern Tumor Collaboration Group (ECOG) physical states score is 0 to 2;\n* Informed Consent Form is signed by patients or legal agents.\n\nExclusion Criteria:\n\n* BCR-ABL positive Chronic Myelogenous Leukemia (CML) and Ph chromosomal negative classic myeloproliferative Neoplasms, such as essential thrombocytosis (ET), polycythemia vera (PV) and primary myelofibrosis (PMF) ;\n* Low risk or inter-1 risk CMML patients according to CPSS-MOL or MMM scores; other types of MDS\u002FMPN with less than 5% bone marrow blasts;\n* Patients with Neut\\\u003C2x109\u002FL, PLT\\\u003C25x109\u002FL;\n* Secondary acute leukemia, myeloid sarcoma, and blast phase of aCML;\n* Patients who are allergic to any drug involved in the trial;\n* Pregnancy, lactating Women, and patients who are unwilling to use contraceptives;\n* Patients with abnormal Liver and kidney function which exceeded the inclusion criteria;\n* Patients with organic heart disease with clinical symptoms or heart dysfunction (NYHA ≥ level 2);\n* Patients with other malignancies at the same time except the following situations:\n\nPatients had received treatment for the purpose of cure and had no active malignancies for at least 5 years prior to enrollment; 2)Patients had received sufficient treatment, non-melanoma skin cancer or malignant freckles -like moles with no signs of illness (even if random grouping is less than 3 years); 3)Received sufficient treatment, in situ cancer without signs of illness (even if the random group is less than 3 years);\n\n* Patients with AIDS, syphilis, active hepatitis B (HBV-DNA can be measured) and hepatitis C;\n* Patients with cardiovascular diseases with clinical significance, such as arrhythmia that have not been controlled or have symptoms, congestive heart failure or myocardial infarction within 6 months, or level 3 (moderate) or level 4 (Severe) heart disease (NYHA according to the New York Heart Society's functional grading method);\n* Patients with any situations that might interfere with research procedures or results, or have the medical status or disease that will bring a certain risk to participating in this study judged by researchers (such as activity systemic infection);\n* Patients who can't understand or follow the research plan;\n* Patients who are under 18 or over 80 years old;\n* Patients who underwent a major surgery within 4 weeks before the random grouping;\n* Patients who are participating in other clinical trials one month before joining the group;\n* Patients who rely on illegal drugs;\n* Patients with psychological disorders or cognitive disorders","80 Years",{"count":80,"type":21},50,[25],"This study observes the safety and efficacy of Azacitidine (AZA) combined with ruxolitinib to treat higher-risk Myelodysplastic Syndromes∕Myeloproliferative Neoplasms(MDS\u002FMPN)",[28],"2023-04-17",{"date":86,"type":33},"2023-04-18",{"date":88,"type":33},"2022-11-01",{"date":90,"type":21},"2026-12-30",{"name":92,"class":40},"The First Affiliated Hospital with Nanjing Medical University"]