[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-high-risk-myelodysplastic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-high-risk-myelodysplastic-syndrome":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,72],{"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":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100366159","phase-1-cladribine-idarubicin-cytarabine-and-quizartinib-in-treating-patients-with-newly-diagnosed-relapsed-or-refractory-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100366159",false,"NCT04047641","Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","A Combination of Cladribine, Idarubicin, Cytarabine (CLIA) and Quizartinib for the Treatment of Patients With Newly Diagnosed or Relapsed\u002FRefractory Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS))","Inclusion Criteria:\n\n* Diagnosis of\n\n  * AML (World Health Organization \\[WHO\\] classification definition of \\>= 20% blasts, excluding Acute promyelocytic leukemia),\n  * Acute biphenotypic leukemia or\n  * High-risk MDS (\\> 10% bone marrow blasts)\n* Frontline cohort: Patients aged 18 to 65 years\n* Relapse cohort: Patients aged \\>=18 years old\n* Patients may be newly diagnosed (Frontline cohort) or with prior therapy (Relapsed cohort) as follows:\n\n  * For frontline cohort: Patients must be chemonaive, i.e., not have received any chemotherapy (except hydroxyurea \\[Hydrea\\] \\[no dose limit\\], tretinoin \\[atra\\] \\[no dose limit\\] or ara-C \\[one or two doses (max 2 gr\u002Fm\\^2 per dose)\\] for transient control of hyperleukocytosis) for AML or MDS. They may have received hypomethylating agents for prior MDS and transfusions, hematopoietic growth factors or vitamins. Temporary prior measures such as apheresis or Hydrea are allowed\n  * For relapsed cohort: Patients with previously treated, relapsed or refractory AML, acute biphenotypic leukemia or high-risk MDS (\\> 10% bone marrow blasts)\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Creatinine \\\u003C 1.5 mg\u002Fdl\n* Total bilirubin \\\u003C 1.5 mg\u002FdL, unless increase is due to hemolysis or congenital disorder\n* Transaminases (serum glutamate pyruvate transaminase \\[SGPT\\]) \\\u003C 2.5 x upper limit of normal (ULN)\n* Potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limits\n* Ability to take oral medication\n* Ability to understand and provide signed informed consent\n* Baseline test of left ventricular ejection fraction \\>= 50%\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days\n* WOCBP must use appropriate method(s) of contraception such as oral contraceptive pills (OCP), birth control shots, intrauterine device (IUD) etc. WOCBP should use an adequate method to avoid pregnancy until 30 days after the last dose of investigational drug. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as men with known azoospermia do not require contraception\n* Patients with isolated extramedullary myeloid neoplasm will be eligible\n\nExclusion Criteria:\n\n* Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results\n* Breastfeeding women\n* Patients with current active malignancies or any remission for \\\u003C 6 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may be in remission for less than 6 months or have active disease\n* Active clinically serious and uncontrolled infection. Patients with recent infections must have no temperature of \\>= 101 degrees Fahrenheit (F) for at least 48 hours (hrs) (before first dose, day 1)\n* Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of quizartinib\n* Documented active central nervous system leukemia (patients with history of central nervous system \\[CNS\\] leukemia without active disease are allowed)\n* Patients with a known confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis\n* Patients who have had any major surgical procedure within 14 days of day 1\n* Impaired cardiac function including any of the following:\n\n  * Screening electrocardiography (ECG) with a corrected QT (QTc) \\> 450 msec. The QTc interval will be calculated by Fridericia's correction factor (QTcF). The QTcF will be derived from the average QTcF in triplicate. Patients are excluded if they have QTcF \\>= 450. Subjects with prolonged QTcF interval in the setting of RBBB (right bundle branch block) may participate upon review and approval by the medical monitor. RBBB for patients' triplicate electrocardiograms (EKGs) can show false QTc prolongation; therefore, the cardiology collaborator for this study will manually review to provide an accurate reading of the QTc\n  * Patients with congenital long QT syndrome\n  * Sustained ventricular tachycardia requiring medical intervention\n  * Any history of clinically significant ventricular fibrillation or torsades de pointes\n  * Known history of second or third degree heart block (may be eligible if the patient currently has a pacemaker)\n  * Heart rate of \\\u003C 50\u002Fminute on pre-entry ECG\n  * Left bundle branch block\n  * Right bundle branch block + left anterior hemiblock (bifascicular block)\n  * Patients with myocardial infarction or unstable angina within 6 months prior to starting study drug\n  * Congestive heart failure (CHF) New York (NY) Heart Association class III or IV\n  * Atrial fibrillation documented within 2 weeks prior to first dose of study drug\n  * Known family history of congenital long QT syndrome\n  * Patients who are actively taking a strong CYP3A4 inducing medication","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This phase I\u002FII trial studies the side effects and how well cladribine, idarubicin, cytarabine, and quizartinib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory). Drugs used in chemotherapy, such as cladribine, idarubicin, and cytarabine, 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. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving quizartinib with cladribine, idarubicin, and cytarabine may help to control acute myeloid leukemia or high-risk myelodysplastic syndrome.",[27,28,29,30,31,32,33,34],"Acute Myeloid Leukemia","Blasts 20 Percent or More of Bone Marrow Nucleated Cells","High Risk Myelodysplastic Syndrome","Recurrent Acute Biphenotypic Leukemia","Recurrent Acute Myeloid Leukemia","Recurrent High Risk Myelodysplastic Syndrome","Refractory Acute Myeloid Leukemia","Refractory High Risk Myelodysplastic Syndrome","RECRUITING","2026-06-10",{"date":38,"type":39},"2026-06-12","ACTUAL",{"date":41,"type":39},"2019-10-22",{"date":43,"type":20},"2027-12-31",{"name":45,"class":46},"M.D. Anderson Cancer Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":71,"locationsCount":47},"100354542","phase-1-cpx-351-in-treating-patients-with-relapsed-or-refractory-high-risk-myelodysplastic-syndrome-or-chronic-myelomonocytic-leukemia-100354542","NCT03896269","CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia","Phase 1 Dose Escalation Study of CPX-351 for Patients With Int-2 or High Risk IPSS Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia After Failure to Hypomethylating Agents","Inclusion Criteria:\n\n* Diagnosis of MDS or chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO)\n* Patients are either not eligible for or choose not to proceed with a stem cell transplant at the time of enrollment\n* MDS and CMML classified by International Prognostic Scoring System (IPSS) as intermediate-2\u002Fhigh risk with excess blasts \\> 5%, or with 10-19% bone marrow blasts\n* No response following at least 4 cycles of therapy or relapse after initial CR, partial response (PR), or HI or progression after any number of cycles of either azacitidine, decitabine, guadecitabine or ASTX727 (oral decitabine) as single agents or in combination with other investigational agents\n* Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study\n* Total bilirubin \\\u003C 3 mg\u002FdL (will allow less than 5 x upper limit of normal \\[ULN\\] if Gilbert's at investigator's discretion)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Serum creatinine clearance \\> 30 mL\u002Fmin and no end\u002Fstage renal disease\n* Hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, granulocyte-colony stimulating factor \\[G-CSF\\], granulocyte-macrophage colony-stimulating factor \\[GM-CSF\\], procrit, aranesp, thrombopoietins) is allowed at any time prior to or during study if considered to be in the best interest of the patient\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50 by echocardiogram or multigated acquisition (MUGA) scan\n* History of myocardial infarction within the last 6 months or unstable\u002Funcontrolled angina pectoris or history of severe and\u002For uncontrolled ventricular arrhythmias\n* Uncontrolled infection not adequately responding to appropriate antibiotics\n* Female patients who are pregnant or lactating\n* Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \\[birth control pills\\], contraceptive injections, intrauterine devices \\[IUD\\], double-barrier method \\[spermicidal jelly or foam with condoms or diaphragm\\], contraceptive patch, or surgical sterilization) throughout the study\n* Female patients with reproductive potential who have a positive urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening\n* Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment)\n* Prior cumulative anthracycline exposure of \\> 550 mg\u002Fm\\^2 daunorubicin or equivalent, or \\> 400 mg\u002Fm\\^2 in patients who received radiation therapy to the mediastinum",{"count":56,"type":20},38,[23],"This phase I trial studies best dose and side effects of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and how well it works in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, 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.",[60,61,62,63,32,64,34],"Blasts 10-19 Percent of Bone Marrow Nucleated Cells","Blasts More Than 5 Percent of Bone Marrow Nucleated Cells","High Risk Chronic Myelomonocytic Leukemia","Recurrent Chronic Myelomonocytic Leukemia","Refractory Chronic Myelomonocytic Leukemia","2026-05-18",{"date":67,"type":39},"2026-05-20",{"date":69,"type":39},"2019-05-14",{"date":43,"type":20},{"name":45,"class":46},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":5},"100315211","phase-2-azacitidine-and-enasidenib-in-treating-patients-with-idh2-mutant-myelodysplastic-syndrome-100315211","NCT03383575","Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome","Targeted Therapy With the IDH2-Inhibitor Enasidenib (AG221) for High-Risk IDH2-Mutant Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Signed, informed consent must be obtained prior to any study specific procedures\n* Subjects with a histologically confirmed diagnosis of MDS, including both MDS and refractory anemia with excess blasts in transformation (RAEB-T) (acute myeloid leukemia \\[AML\\] with 20-30% blasts and multilineage dysplasia by French-American-British \\[FAB\\] criteria) by World Health Organization (WHO), and chronic myelomonocytic leukemia (CMML) are eligible\n* Subjects must have an IDH2 gene mutation (IDH2-R140 or R172) as determined by local laboratory result\n* (Arm A only): Subject must be hypomethylating agent naive (i.e. prior azacitidine, decitabine, SGI-110 is exclusionary). Receipt of other MDS-directed therapy such as lenalidomide is allowed\n* (Arm A only): Subjects with high-risk MDS (i.e. International Prostate Symptom Score \\[IPSS\\] intermediate-2 or high-risk; or revised \\[R\\]-IPSS high or very-high risk). Patients with intermediate-1 risk by IPSS or intermediate risk by R-IPSS with high-risk molecular features including TP53, ASXL1, EZH2, and\u002For RUNX1 mutations are also eligible\n* (Arm B only): Subject must be relapsed or refractory to prior hypomethylating agent therapy, defined as prior receipt of 6 cycles of HMA therapy with failure to attain a response, or relapse after prior response to HMA therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Serum bilirubin =\\\u003C 2 x the upper limit of normal (ULN) (except for patients with Gilbert's disease)\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) =\\\u003C 3 x the laboratory ULN\n* Serum creatinine =\\\u003C 2 x the ULN\n* Able to understand and voluntarily sign a written informed consent, and willing and able to comply with protocol requirements\n* Resolution of all clinically significant treatment-related, non-hematological toxicities, except alopecia, from any previous cancer therapy to =\\\u003C grade 1 prior to the first dose of study treatment\n* Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days of the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of 3 months following the last dose of study drug. Post-menopausal females (\\> 45 years old and without menses for \\> 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for a minimum of 3 months following the last dose of study drug if sexually active with a female of childbearing potential\n\nExclusion Criteria:\n\n* Any prior or coexisting medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study\n* Subject has received a prior targeted IDH2 inhibitor\n* Psychiatric disorders or altered mental status precluding understanding of the informed consent process and\u002For completion of the necessary study procedures\n* Active uncontrolled infection at study enrollment including known diagnosis of human immunodeficiency virus or chronic active hepatitis B or C infection\n* Clinically significant gastrointestinal conditions or disorders that may interfere with study drug absorption, including prior gastrectomy\n* Patients with known active central nervous system (CNS) disease, including leptomeningeal involvement\n* Impaired cardiac function, uncontrolled cardiac arrhythmia, or clinically significant cardiac disease including the following: a) New York Heart Association grade III or IV congestive heart failure, b) myocardial infarction within the last 6 months\n* Subjects with a corrected QT (QTc) \\> 480 ms (QTc \\> 510 msec for subjects with a bundle branch block at baseline\n* Nursing or pregnant women\n* Subjects with known hypersensitivity to study drugs or their excipients","12 Years",{"count":81,"type":20},63,[24],"This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.",[27,85,86,87,88,32,34],"Blasts 20-30 Percent of Bone Marrow Nucleated Cells","Chronic Myelomonocytic Leukemia","IDH2 Gene Mutation","Myelodysplastic Syndrome With Excess Blasts","2026-02-13",{"date":91,"type":39},"2026-02-17",{"date":93,"type":39},"2018-01-17",{"date":95,"type":20},"2027-02-28",{"name":45,"class":46}]