[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597554":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":51,"centralContacts":56,"locations":66,"responsibleParty":86,"collaborators":29,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":29,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":29,"enrollmentInfo":97,"targetDuration":29,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":111,"whyStopped":29,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"The Methodist Hospital Research Institute","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"HMA- Based Treatment Arm","ACTIVE_COMPARATOR","Azacitidine or Decitabine with or without Venetoclax (HMA-based treatment):\n\n* Venetoclax is a BCL-2 inhibitor FDA Approved for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, in combination with azacitidine, decitabine or low-dose cytarabine in.\n* Decitabine is a nucleoside metabolic inhibitor that is administered as an intravenous infusion over a 1-3 hours.\n* Azacitidine can be given as a sub-cutaneous injection or intravenously. In AML, the most common adverse reactions (≥30%) in combination with azacitidine or decitabine or low-dose cytarabine were nausea, diarrhea, thrombocytopenia, constipation, neutropenia, febrile neutropenia, fatigue, vomiting, peripheral edema, pyrexia, pneumonia, dyspnea, hemorrhage, anemia, rash, abdominal pain, sepsis, back pain, myalgia, dizziness, cough, oropharyngeal pain, and hypotension.",[13,14,15,16],"Diagnostic Test: 5hmC Biomarker","Drug: Venetoclax","Drug: Decitabine 20 mg\u002Fm²\u002Fday for 5 days","Drug: Azacitidine (AZA)",{"label":18,"type":10,"description":19,"interventionNames":20},"Intensive Chemotherapy Arm","Cytarabine with Anthracycline (standard intensive induction therapy):\n\n* Cytarabine is FDA approved chemotherapy (pyrimidine analog) infusion that is frequently used with other drug such as anthracycline to treat acute myeloid leukemia, acute lymphoblastic leukemia. Common side effects include low counts, immune suppression, nausea, neutropenic fever.\n* Anthracyclines are chemotherapy infusions which topoisomerase II inhibition. Other than having side effects similar to cytarabine, it may cause weakening of heart pumping function few years later. Both of these medications may cause a temporary loss of hair in some people. After treatment with cytarabine has ended, normal hair growth should return.",[13,21,22],"Drug: Cytarabine (Ara-C)","Drug: Anthracycline",[24,30,35,39,43,47],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DIAGNOSTIC_TEST","5hmC Biomarker","The 5hmC marker will be used to determine treatment modality post-induction therapy. After Week 4 of standard-of-care therapy (either HMA-based treatment or intensive induction chemotherapy), 5hmC biomarker testing will be performed. If MRD is positive, patients will continue the same standard-of-care treatment or crossover to the other arm of the study. If MRD is negative, patients will proceed with consolidation (either HSCT or continue on same treatment). For patients receiving HMA-based treatment, blood samples will be collected ± 5 days before and after 4 and 12 weeks of therapy. For patients receiving intensive chemotherapy blood samples will be collected ± 5 days before and after 4 and 12 weeks of therapy.",[9,18],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"DRUG","Venetoclax","Venetoclax is a BCL-2 inhibitor FDA Approved for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, in combination with azacitidine, decitabine or low-dose cytarabine.",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"Decitabine 20 mg\u002Fm²\u002Fday for 5 days","Decitabine is a nucleoside metabolic inhibitor that is administered as an intravenous infusion over a 1-3 hours.",[9],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"Azacitidine (AZA)","Azacitidine can be given as a sub-cutaneous injection or intravenously.",[9],{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"Cytarabine (Ara-C)","Cytarabine is FDA approved chemotherapy (pyrimidine analog) infusion that is frequently used with other drug such as anthracycline to treat acute myeloid leukemia, acute lymphoblastic leukemia. Common side effects include low counts, immune suppression, nausea, neutropenic fever.",[18],{"type":31,"name":48,"description":49,"armGroupLabels":50,"otherNames":29},"Anthracycline","Anthracyclines are chemotherapy infusions which topoisomerase II inhibition. Other than having side effects similar to cytarabine, it may cause weakening of heart pumping function few years later. Both of these medications may cause a temporary loss of hair in some people. After treatment with cytarabine has ended, normal hair growth should return.",[18],[52],{"name":53,"affiliation":54,"role":55},"Shilpan Shah, MD","Houston Methodist Neal Cancer Center","PRINCIPAL_INVESTIGATOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":29,"email":61},"Danielle Sewell","CONTACT","3462382674","dmsewall@houstonmethodist.org",{"name":63,"role":59,"phone":64,"phoneExt":29,"email":65},"Titilayo Olubajo","7133639803","tolubajo@houstonmethodist.org",[67],{"facility":54,"status":29,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Houston","Texas","77030","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-95.36327,29.76328,{"lat":77,"lon":76},[80,83],{"name":53,"role":59,"phone":81,"phoneExt":29,"email":82},"713-441-9948","sshah2@houstonmethodist.org",{"name":84,"role":59,"phone":29,"phoneExt":29,"email":85},"Siddhartha Ganguly, MD","sganguly@houstonmethodist.org",{"type":87,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100597554","phase-2-efficacy-of-hypomethylating-agents-vs-intensive-chemotherapy-in-acute-myeloid-leukemia-using-5hmc-as-a-blood-based-minimal-residual-disease-marker-100597554",false,"NCT07060001","Efficacy of Hypomethylating Agents vs. Intensive Chemotherapy in Acute Myeloid Leukemia Using 5hmC as a Blood-Based Minimal Residual Disease Marker","Evaluation of the Efficacy of Hypomethylating Agent Versus Standard Intensive Chemotherapy Induction Based on 5hmC - a Novel, Blood Epigenetic Marker for Assessing Measurable Residual Disease in Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. The patient (or legally acceptable representative if applicable) provides written informed consent for the trial. Spanish speaking patients will be included and translation services will be provided as needed.\n2. Male or female, 18 years of age or older, on the day of informed consent signing.\n3. Newly diagnosed de novo AML\n\n5\\. Expected life expectancy of at least 6 months 6. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations. 7. Women with childbearing potential and men should practice at least one of the following methods of birth control throughout the study and for 6 for women and 3 months for men after the last dose of study therapy:\n\n1. Total abstinence from sexual intercourse (periodic abstinence not acceptable);\n2. Surgically sterile partner(s) including vasectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;\n3. Practicing 2 effective methods of contraception (at least 1 highly effective, method of contraception \\[See Appendix 4\\]). WOCBP should only be included after a confirmed negative serum pregnancy test.\n\nExclusion Criteria:\n\n1. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of trial treatment administration.\n2. The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study\n3. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n4. Confirmed positive pregnancy test in WOCBP.","ALL","18 Years",{"count":98,"type":99},112,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","This is a therapeutic intervention trial evaluating the clinical utility of a novel blood-based epigenetic biomarker-genome-wide 5-hydroxymethylcytosine (5hmC) in cell-free DNA (cfDNA)-for assessing measurable residual disease (MRD) in patients with newly diagnosed acute myeloid leukemia (AML). The study compares the efficacy of hypomethylating agent (HMA)-based therapy versus intensive induction chemotherapy, using the 5hmC biomarker to guide post-induction treatment decisions. Approximately 112 adult patients will be enrolled and assigned to treatment arms based on a stratified sampling scheme. Blood samples will be collected at defined intervals to assess MRD status. Primary endpoints include minimal residual disease (MRD) negativity rate, duration of remission, event-free survival (EFS), and overall survival (OS).",[105,106],"Acute Myeloid Leukemia (AML)","Acute Myeloid Leukaemia (AML)",[108,109,110],"AML","Leukemia","Acute Myeloid Leukemia","NOT_YET_RECRUITING","2026-03-05",{"date":114,"type":115},"2026-03-06","ACTUAL",{"date":117,"type":99},"2026-04",{"date":119,"type":99},"2029-12",{"name":5,"class":6},1]