[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-with-gene-mutations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-with-gene-mutations":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100400356","phase-2-cpx-351-and-ivosidenib-for-the-treatment-of-idh1-mutated-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100400356",false,"NCT04493164","CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the principal investigator (PI)\n* Treatment naive or relapsed\u002Frefractory AML who are eligible for intensive chemotherapy. Patients with high-risk MDS or MPN (defined as International Prognostic Scoring System Revised \\[IPSS-R\\] score ≥ 4 or dynamic \\[D\\]-IPSS ≥ 3) may also be eligible after discussion with the PI\n* Adequate hepatic function (direct bilirubin ≤ 2 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤ 3 x ULN unless deemed to be related to underlying leukemia\n* Adequate renal function including creatinine clearance ≥ 30 ml\u002Fmin based on the Cockcroft-Gault equation.\n* Willing and able to provide informed consent\n* In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.\n* Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug\n\nExclusion Criteria:\n\n* Patients who have previously received CPX-351.\n* Patients with any concurrent uncontrolled clinically significant medical condition including infection, laboratory abnormality, or psychiatric illness, which could place the patient at unacceptable risk of study treatment.\n* The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea, and\u002For cytarabine (1 or 2 doses; up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy.\n* Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI).\n* Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n* Patients with symptomatic congestive heart failure (NYHA Class III or IV), unstable angina, or an ejection fraction \\\u003C 45%.\n* Patients with prior anthracycline exposure of \\> 360 mg\u002Fm2 daunorubicin (or equivalent), or \\> 210 mg\u002Fm2 daunorubicin (or equivalent) in patients with prior mediastinal radiation.\n* QTc interval using Fridericia's formula (QTcF) \\> 470 msec. A prolonged QTc interval in the setting of right bundle branch block is permitted after discussion with the PI.\n* Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception\n\n  a. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).\n* Subjects with a known medical history of progressive multifocal leukoencephalopathy (PML).\n* Subjects taking strong CYP3A4 inducers are excluded from the study unless they can be transferred to other medications within ≥ 5 half-lives prior to dosing\n* Patients with a diagnosis of acute promyelocytic leukemia (APL).\n* Unresolved toxicities \\> grade 1 from prior treatment including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation. The safety of this drug combination will also be studied. IDH1 is a type of genetic mutation (change). Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to learn if CPX-351 in combination with ivosidenib can help to control IDH1-mutated acute myeloid leukemia or high-risk myelodysplastic syndrome.",[26,27,28,29,30],"Acute Myeloid Leukemia With Gene Mutations","Myelodysplastic Syndrome","Myeloproliferative Neoplasm","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","RECRUITING","2026-06-10",{"date":34,"type":35},"2026-06-12","ACTUAL",{"date":37,"type":35},"2020-12-30",{"date":39,"type":20},"2028-06-01",{"name":41,"class":42},"M.D. Anderson Cancer Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100631982","phase-2-oral-decitabine-plus-ivosidenib-as-first-line-for-olderunfit-adult-aml-patients-100631982","NCT07507760","Oral Decitabine Plus Ivosidenib as First Line for Older\u002FUnfit Adult AML Patients","A Phase II, Multicentre, Open Label Clinical Trial Evaluating the Efficacy and Safety of Oral Decitabine Plus Ivosidenib in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia Older Than 60 Years Old and\u002For Who Are Ineligible for Standard Induction Chemotherapy","DECISIVO","Inclusion Criteria:\n\n1. Morphological diagnosis of AML (WHO criteria 2022)\n2. Newly diagnosed AML.\n3. IDH1 R132 mutations (centrally assessed by PCR and NGS). A patient will be allowed to be included with local result after approval of the medical monitor.\n4. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2 if ≥ 60 years of age, or 0 to 3 if ≥ 18 to 60 years.\n5. Age ≥ 18 years with comorbidities contraindicating intensive chemotherapy; or age ≥ 60 years.\n\n   * ≥ 60 years of age;\n   * or ≥ 18 to 60 with at least one of the following co-morbidities:\n\n     * ECOG Performance Status of 2 or 3;\n     * Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 55% or chronic stable angina;\n     * DLCO ≤ 65% or FEV1 ≤ 65% or significant history of chronic pulmonary obstructive;\n     * Creatinine clearance ≥ 25 mL\u002Fmin to \\\u003C 50 ml\u002Fmin\n     * Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0 × ULN\n     * Non active\u002Fcontrolled prior neoplastic disease\n     * Any other patient´s comorbidity or disease condition that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the PETHEMA medical monitor before study enrolment (e.g, prior MDS or MPS, high-risk cytogenetics)\n6. Patients \\\u003C70 years, with favorable risk AML according to ELN will be included only if they are not candidates to standard treatment with intensive chemotherapy.\n7. Adequate renal function as demonstrated by a creatinine clearance ≥ 25 mL\u002Fmin (calculated by the Cockcroft Gault formula).\n8. Adequate liver function as demonstrated by: aspartate aminotransferase (AST) ≤ 5.0 × ULN, alanine aminotransferase (ALT) ≤ 5.0 × ULN, bilirubin ≤ 2.5 × ULN (unless considered to be due to leukemic disease, in which case it should be approved by the PETHEMA medical monitor).\n9. Subject has a white blood cell count \\\u003C 30 × 109\u002FL (Hydroxyurea is permitted to meet this criterion)\n10. Female subjects must be either postmenopausal OR permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy) OR Women of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control. Female subjects of childbearing potential must have negative results for pregnancy tests performed along the study (screening and every three cycles). A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.\n11. Male subjects who are sexually active, must agree, from Study Day 1 through at least 90 days after the last dose of study drug, to practice the protocol specified contraception.\n12. Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.\n\nExclusion Criteria:\n\n1. Subject has history of myeloproliferative neoplasm \\[MPN\\] with BCR-ABL1 translocation and AML with BCR-ABL1 translocation.\n2. Prior therapy for AML (except hydroxiurea).\n3. Genetic diagnosis of acute promyelocytic leukemia.\n4. Subject is known to be positive for HIV (HIV testing is not required.)\n5. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required).\n6. Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients that in the opinion of the investigator would adversely affect his\u002Fher participating in this study.\n7. Any severe uncontrolled systemic infection.\n8. Subject has a history of other malignancies within 1 year prior to study entry which is not controlled and\u002For requiring active therapy which may compromise the administration of IVO and oral decitabine.\n9. Creatinine clearance \\\u003C25 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n10. Inadequate liver function as demonstrated by AST or ALT \\> 5.0 × ULN, or bilirubin \\> 2.5 × ULN (unless considered to be due to leukemic disease, in which case it should be approved by the PETHEMA medical monitor)\n11. Subject has a white blood cell count \\> 30 × 109\u002FL that is not controlled using hydrea or 1 gr\u002Fsqm\u002Fday per 1 day of cytarabine.\n12. Contraindications for IVO or oral decitabine according to the SmPC.\n13. Patient has a heart rate-corrected QT interval using Fridericia's method QT for corrected heart rate (QTcF) ≥450 msec or any other factor that increases the risk of QT prolongation or arrhythmic events (e.g., hypokalemia, family history of long QT interval syndrome). Patients with prolonged QTcF interval in the setting of bundle branch block may participate in the trial.",{"count":53,"type":20},50,[23],"The goal of this clinical trial is to learn if the combination of oral decitabine plus ivosidenib works to treat naïve adult patients with acute myeloid leukemia (AML) with IDH1 R132 mutation older than 60 years old or those who are older than 18 years old with defined comorbidities that make them not suitable for standard induction therapy. The main objectives of this clinical trial are:\n\n* Asses the Complete Remission (CR) and Complete Remission with incomplete marrow recovery (CRi) rates of this treatment.\n* Determine the incidence and severity of all adverse events (AEs).\n\nAll participants will receive oral ivosidenib and oral decitabine in treatment cycles of 28 days until disease progression, lack of clinical benefit or the end of the study. Patients who achieve CR\u002FCRi will be elegible to receive allogeneic stem cell transplantation.",[26],[58,59,60,61,62,63,64],"AML","older adult","unfit","IDH1 R132 mutation","Decitabine","Ivosidenib","allogeneic stem cell transplant","NOT_YET_RECRUITING","2026-03-27",{"date":68,"type":35},"2026-04-02",{"date":70,"type":20},"2026-04",{"date":72,"type":20},"2029-04",{"name":74,"class":42},"PETHEMA Foundation",15]