[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mdsaml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mdsaml":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100642495","phase-1-a-phase-1b2-study-of-ropeginterferon-alfa-2b-added-to-azacitidine-in-newly-diagnosed-mdsaml--10-blasts-with-tp53-mutations-100642495",false,"NCT07646821","A Phase 1b\u002F2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in Newly Diagnosed MDS\u002FAML (≥ 10% Blasts) With TP53 Mutations","Eligibility Criteria\n\nParticipants with following:\n\ni) Adult participants (≥ 18 years) with newly diagnosed MDS\u002FAML ≥ 10% blasts with TP53 aberration\n\n* TP53 aberration defined by:\n\n  * Single TP53 mutation\\> 10% VAF\n  * ≥ 1 mutation of any VAF, irrespective of cytogenetics or TP53 allele loss\n  * Single TP53 mutation 5-10% with complex karyotype and\u002For TP53 allele loss\n* (TP53 mutation will include any known pathogenic missense, truncating or splicing mutations (defined as Tier 1 or 2 in the UT MD Anderson CLIA lab myeloid NGS panel or validated by molecular pathologist; TP53 allele loss on FISH should be at least \\> 5%) ii) Ineligible for intensive chemotherapy\n\n  * Adult participants ≥ 60 years of age, OR\n  * Adult participants 18 to 60 years of age with at least one of the following relevant clinical situations\u002Fstatus:\n  * Eastern cooperative oncology group (ECOG) performance status ≥2\n  * Clinically significant organ comorbidities, as reflected by at least 1 of:\n\n    * Left ventricular ejection fraction (LVEF) \\\u003C\u002F= 50%\n    * Chronic stable angina or congestive heart failure controlled with medication\n    * Creatinine clearance \\\u003C 45 ml\u002Fmin calculated by the Cockcroft-Gault formula or measured by 24 hours' urine collection\n    * Impaired pulmonary function: Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected\n    * Forced expiratory volume in 1 second (FEV1) ≤65% of expected\n    * Other contraindication(s) to anthracycline therapy (must be documented).\n    * Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the PI.\n  * Adequate hepatic function defined by\n\n    * Serum AST\u002FALT ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n    * Serum total bilirubin \\\u003C 2x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.\n  * The teratogenic effect of AZA is not well studied. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy UT MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participants presents with an applicable exclusionary factor which may be one of the following:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n\nApproved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n* Men treated or enrolled on this protocol must also agree to use adequate contraception, for the duration of study participation, and 4 months after completion of AZA administration.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Participants with a prior or concurrent malignancy may be eligible after discussion with the investigator\u002F PI\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Adult participants with MDS\u002FAML without a known pathogenic TP53 mutation\n* Treated secondary AML (AML developing after prior exposure to hypomethylating agents, chemotherapy or allogeneic HSCT for previous myeloid disorders like MDS, CMML, other MDS\u002FMON overlap syndromes)\n* Post MPN AML (advanced phase MPN)\n* Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation\n* Participants with active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).\n* Participants with known and untreated major depressive disorder\n* Participants with known and active autoimmune disorder\n* Participants with known retinal disease except for known age related macular degeneration\n* Participants with another active cancer warranting therapy. A maintenance therapy for a stable\u002Ftreated prior cancer is acceptable if it does not interfere with the trial therapy. This needs to be discussed with the PI.\n* Participants who are receiving any other leukemia treatment.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ropeginterferon alfa-2b, AZA or other agents used in study.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because AZA and potentially rIFN\\_A has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infant's secondary to treatment of the mother with the combination, breastfeeding should be discontinued if the mother is treated with combination. These potential risks may also apply to other agents used in this study.","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS\u002FAML with TP53 mutations. To learn if the recommended dose of ropeinterferon alfa-2b found in Dose Escalation in combination with azacitidine can help to control the disease.",[26,27,28,29],"Ropeginterferon","Alfa-2b","Azacitidine","MDS\u002FAML","NOT_YET_RECRUITING","2026-06-09",{"date":33,"type":34},"2026-06-15","ACTUAL",{"date":36,"type":19},"2026-11-27",{"date":38,"type":19},"2030-12-11",{"name":40,"class":41},"M.D. Anderson Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100152153","registry-study-on-patient-characteristics-biological-disease-profile-and-clinical-outcome-in-acute-myeloid-leukemia-and-related-neoplasms---the-biology-and-outcome-bio-project-100152153","NCT01252485","Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project","AMLSG BiO","Inclusion Criteria:\n\n* Patients with suspected diagnosis of acute myeloid leukemia and related neoplasms, newly diagnosed or relapsed\u002Frefractory, classified according to the International Consensus Classification\n* Age ≥ 18 years. There is no upper age limit.\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Severe neurological or psychiatric disorder interfering with ability to give an informed consent\n* No consent for registration, storage and processing of the individual patient and disease characteristics and course as well as information of the family physician about study participation\n* No consent for biobanking of patient's biological specimens and performance of analyses on stored material.",{"count":51,"type":19},50000,"OBSERVATIONAL","This is a registry study in adult patients with newly diagnosed or refractory\u002Frelapsed myeloid neoplasms\n\nInvestigator's sites: 80-90 sites in Germany and Austria\n\nEstimated duration of observation of an individual patient:\n\n10 years maximum\n\nObjectives\n\n* To register all patients with AML and related neoplasms, newly diagnosed or relapsed\u002Frefractory in all AMLSG participating centers (completeness)\n* To perform rapid analyses of disease-related genetic markers (incidences, treatment recommendations)\n* To assess patient and family history, as well as patient characteristics\n* To evaluate treatment response (CR, CRh, CRi) and outcome data (event-free survival \\[EFS\\], relapse-free survival \\[RFS\\], cumulative incidence of relapse \\[CIR\\], cumulative incidence of death \\[CID\\], overall survival \\[OS\\])\n* To evaluate the impact of measurable residual disease (MRD) by different methods\n* To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)\n* To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue; e.g., skin biopsy, finger nails, hairs, sputum, or urine)",[55,29],"Acute Myeloid Leukemia (AML)",[57,58,59,29],"AML","Registry study","Biology and Outcome","RECRUITING","2025-12-29",{"date":63,"type":34},"2026-01-05",{"date":65,"type":34},"2010-07-06",{"date":67,"type":19},"2044-12-31",{"name":69,"class":41},"University of Ulm",94,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":15,"minAge":16,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":20,"phases":82,"briefSummary":76,"conditions":83,"keywords":86,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":42},"100609398","phase-2-venetoclax--augmented-treosulfan-based-reduced-intensity-conditioning-before-allogeneic-stem-cell-transplantation-100609398","NCT07214064","Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation","Safety and Feasibility of a Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation in AML, MDS\u002FAML and Higher Risk MDS","Inclusion Criteria:\n\n1. Age between 18 and 75 years at the time of signing the Informed Consent\n2. Patient is fluent in German\n3. Signed written Informed Consent with the cognitive ability to understand all consequences of trial participation and to comply with all trial related procedures\n4. Diagnosis of AML,MDS\u002FAML (according to ICC 20226) or HRMDS (IPSS-R7 \\>3.5 or IPSS-M8 \\>0; according to ICC 20226 and IWG 20232)\n5. Myeloid neoplasm (AML, MDS\u002FAML or HR-MDS according to ICC 20226) under control\\* at time of screening, defined as one of the following:\n\n   5.1. AML (ICC 20226):\n\n   • Scheduled for alloHCT after prior Remission\n\n   Induction ± Consolidation:\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after up to two cycles of intensive, anthracycline-based induction chemotherapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after intensive, anthracycline-based induction chemotherapy folllowed by up to three cycles of cytostatic consolidation therapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221) after less intensive, HMA-based treatment (up to six cycles) OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221) after a combination of intensive and less intensive treatments (up to six cycles in total) 5.2. MDS\u002FAML (ICC 20226):• Scheduled for alloHCT after prior Remission\n\n   Induction ± Consolidation:\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after up to two cycles of intensive, anthracycline-based induction chemotherapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria), after intensive, anthracycline-based induction chemotherapy folllowed by up to three cycles of cytostatic consolidation therapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after less intensive, HMA-based treatment (up to six cycles and including HMA monotherapy) OR\n   * Achievement of at least MLFS (according to ELN 20221 criteria) after a combination of intensive and less intensive treatments (up to six cycles in total)• Scheduled for upfront alloHCT:\n   * ≤19% bone marrow blastsAND• ≤19% peripheral blood blastsAND• ≤15.000\u002Fµl peripheral blood Leukocytes 5.3. HR- MDS (ICC 20226, IWG 20232)\n   * Scheduled for alloHCT after prior therapy:\n   * up to six cycles of a less intensive HMAbased treatment or HMA monotherapy AND\n   * ≤9% bone marrow blastsAND• ≤9% peripheral blood blasts• Scheduled for upfront alloHCT:\n   * ≤9% bone marrow blasts AND\n   * ≤9% peripheral blood blasts \\*The disease is considered clinically controlled, when it is either aggressive but has proven responsive to cytostatic chemotherapy (e.g. AML with achievement of at least MLFS) or slowly progressive ( e.g. suitable for upfront alloHCT in cases of MDS\u002FAML) or is both slowly progressive and responsive to therapy\n\n     * a bone marrow assessment is mandatory during screening phase. Patients canonly be enrolled after the according inclusion criteria have been confirmed bybone marrow biopsy. The time window for bone marrow biopsy is day -21 to -14.\n6. Eligiblity for alloHCT according to a board of experienced haematologists\n7. Karnofsky Performance Index ≥60%\n8. Planned alloHCT with Peripheral Blood Stem Cells (PBSC)\n9. Infusion of allogeneic stem cells schedulded between day 14 and day 28 after Screening\n10. Availability of a suitable donor, defind as one of the following:\n\n    10.1. HLA-identical sibling (MSD)OR 10.2. HLA-compatible (9\u002F10 antigens matched for HLA-A, -B, -C, -DRB1, and -DQB1) unrelated donor (MUD) with completed confirmatory typing.\n\n    OR 10.3. Two unrelated donors with \\>90% probability of a 9\u002F10 match for HLA- A, -B, -C, -DRB1, and -DRQB1, according to OptiMatch list (MUD)\n11. Documented diffusion lung capacity for carbon monoxide (DLCO) \\>40% (adjusted for hemoglobin, if available) and FEV1\u002FFVC \\>50%\n12. Left ventricular ejection fraction (LVEF) ≥40%\n13. GFR (CKD-EPI) ≥ 30 ml\u002Fmin\u002F1,73 m2\n14. Bilirubin ≤3x ULN and AST ≤5x ULN\n15. Thoracic imaging (either X-ray or computed tomography (CT)) without evidence of active infection or second malignancy\n16. Subject (male or female) is willing to use highly effective methods during treatment and for 6 months (male or female) after the end of treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2). Female participants using homonal contraceptives should use a barrier method as well.1 Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success2 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.\n17. Absence of pregnancy confirmed by a highly sensitive pregnancy test not older than 3 days at time of screening (only FCBP).\n18. Subject agrees not to share medication.\n\nExclusion Criteria:\n\n1. APL (AML with t(15;17))\n2. MDS\u002FMPN (ICC 20226)\n3. Karnofsky Performance Index \\\u003C60%\n4. Patient scheduled for haploidentical allogeneic hematopoetic stem cell transplantation or bone marrow stem cell transplantation\n5. Presence of extramedullary myelosarcoma\n6. Disease Relapse after prior CRc\n7. History of allogeneic hematopoietic stem cell transplantation\n8. Significant active cardiac disease within 6 months prior to the start of study treatment, including:\n\n   * New York Heart Association (NYHA) class III or IV congestive heart failure\n   * Myocardial infarction\n   * Unstable angina\n   * Cerebral apoplexy\n   * Severe cardiac arrhythmias\n   * Left ventricular ejection fraction (LVEF) \\\u003C40% by TTE\n9. Documented diffusion lung capacity for carbon monoxide (DLCO) ≤40% (adjusted for hemoglobin, if available) and FEV1\u002FFVC ≤50%\n10. GFR (CKD-EPI) \\\u003C30 ml\u002Fmin\u002F1,73 m2\n11. Bilirubin \\>3x ULN or AST \\>5x ULN\n12. Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia.\n13. Active viral infection, including hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial. An infection controlled with an approved antiviral treatment is allowed.\n14. Presence of Proven, Probable or Possible Invasive Fungal Disease (IFD) as defined by EORTC\u002FMSG 20209 Definitions (please consult Appendix)\n15. Serologies suggestive of recent (\\\u003C6 months) infection or reactivation with\u002Fof Toxoplasma gondii (based on IgG, IgM and Avidity) or of infection with Treponema pallidum (based on TPPA).\n16. Any clinically uncontrolled infection (bacterial or unknown pathogen), defined as persisting or recurring fever or rising levels of CRP (≥10 mg\u002Fdl) despite intravenous antibacterial or antifungal therapy (initiated or escalated at least 72h hours ago)\n17. Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and\u002For disseminated intravascular coagulation.\n18. Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.\n19. Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at \\\u003C30% risk of relapse within one year. However, patients with the following history\u002Fconcurrent conditions are allowed:\n\n    * Basal or squamous cell carcinoma of the skin;\n    * Carcinoma in situ of the cervix;\n    * Carcinoma in situ of the breast;\n    * Incidental histologic finding of prostate cancer.\n20. Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patients, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy)\n21. Severe neurological or psychiatric disorder interfering with ability to give an informed consent.\n22. Women during pregnancy and lactation.\n23. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.\n24. Participation in other trials interfering with the endpoint of this study. Prior trial participation is permitted, provided that treatment with the investigational medicinal product has been completed at least 4 days prior to screening for this trial (at least 10 days before planned study treatment).",true,"75 Years",{"count":81,"type":19},27,[23],[84,29,85],"AML (Acute Myeloid Leukemia)","MDS (Myelodysplastic Syndrome)",[87,88,89,90],"Allogeneic Stem Cell Transplantation","Venetoclax","Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning","RIC","2025-10-02",{"date":93,"type":34},"2025-10-09",{"date":95,"type":19},"2026-01",{"date":97,"type":19},"2027-12",{"name":99,"class":41},"University Hospital Tuebingen"]