[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-with-flt3itd-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-with-flt3itd-mutation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,65,90],{"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":5},"100533189","phase-1-sndx-5613-and-gilteritinib-for-the-treatment-of-relapsed-or-refractory-flt3-mutated-acute-myeloid-leukemia-and-concurrent-mll-rearrangement-or-npm1-mutation-100533189",false,"NCT06222580","SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation","Safety and Efficacy of Dual Menin and FLT3 Inhibition in Patients With Relapsed\u002FRefractory FLT3- Mutated Acute Myeloid Leukemia Containing a Concurrent MLL-Rearrangement or NPM1 Mutation: A Phase I (Ph I) Study of SNDX-5613 + Gilteritinib","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Age ≥ 18 years at the date of signing the informed consent form (ICF)\n* Morphologically confirmed diagnosis of the following based on 2022 World Health Organization (WHO) classification:\n\n  * Relapsed or Refractory Acute Myeloid Leukemia with the following:\n\n    * Refractory disease classified as having received 2 cycles of intensive induction or 2 cycles of hypomethylating agent (HMA) + Venetoclax with persistent disease of ≥ 5% blasts in the bone marrow and\u002For reappearance of peripheral blasts\n  * FLT-3 mutated disease of the ITD or TKD subtype, AND\n  * NPM1 mutation, MLL gene rearrangement and any other mutation that has proven HOXA-MEIS1 overexpression (NUP98, UBTF-TD, MLL-PTD and any others that have supporting literature)\n* Patients must be receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis for at least 24 hours prior to enrollment and while on SNDX-5613 treatment. Patients must not be receiving any other strong CYP3A4 inhibitors\u002Finducers\n* Not suitable for immediate myeloablative\u002Fintensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)\n* Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m\\^2 (estimation based on Modification of Diet in Renal Disease (MDRD) formula, by local laboratory)\n* Adequate cardiac function defined as ejection fraction (EF) of ≥50% by echocardiogram or multigated acquisition (MUGA) scan\n* Patient can communicate with the investigator and has the ability to comply with the requirements of the study procedures\n* Participants of childbearing potential must agree to have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test on the first day of study treatment\n* Participants capable of impregnating others who are having intercourse with people of childbearing potential must agree to abstain from intercourse or have their partner use 2 forms of contraception from the screening visit until 90 days after the last dose of study treatment. They must also refrain from sperm donation from the screening visit until 90 days following the last dose of study treatment\n* Must be able to swallow the study medications\n* Any prior treatment-related toxicities resolved to ≤ grade 1 prior to enrollment, with the exception of ≤ grade 2 neuropathy or alopecia\n* Patients are not currently receiving the following therapies or have discontinued therapy based on the time periods below:\n\n  * Radiation Therapy: At least 60 days from prior total body irradiation (TBI), craniospinal radiation and\u002For ≥ 50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port)\n  * Stem Cell Infusion: At least 60 days must have elapsed from hematopoietic stem cell transplant (HSCT) and at least 4 weeks must have elapsed from donor lymphocyte infusion (DLI)\n  * Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines and checkpoint inhibitors, and at least 21 days since receipt of chimeric antigen receptor therapy or other modified T cell therapy\n  * Antileukemia Therapy\\*\\*\\*: At least 14 days, or 5 half-lives, whichever is shorter, since the completion of antileukemic therapy (for example, but not limited to, small molecule or cytotoxic\u002Fmyelosuppressive therapy), with the following exceptions:\n  * Wah-out can be shorter for patients with rapidly progressing disease as determined by the treating investigator\n  * Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea can be continued concomitantly with SNDX-5613, with medical monitor approval. Patients may continue to receive prophylactic intrathecal chemotherapy at any time at the treating physician's discretion\n  * Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors\n  * Biologics (e.g., monoclonal antibody therapy): At least 90 days, or 5 half-lives, whichever is shorter, since the completion of therapy with an antineoplastic biologic agent\n  * Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily for patients ≥ 18 years or ≤10 mg\u002Fm\\^2 \u002Fday for patients\n\n    * Prior treatment with gilteritinib is allowed\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia\n* Diagnosis of extra-medullary acute myeloid leukemia (AML) based on WHO 2022 classification or myeloid sarcoma\n* Suspected central nervous system (CNS) involvement. Patients with history of cerebrospinal fluid (CSF) involvement must either have documented CSF clearance prior to treatment initiation or be receiving active treatment for CNS involvement\n* Participants with prior malignancy, except:\n\n  * Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study\n  * Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible\n* Previous known allergy\u002Fsensitivity to components of gilteritinib or SNDX-5613. Prior treatment with gilteritinib is allowed and does not exclude a patient\n* Patient with known human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Individuals with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Fridericia's corrected QT interval (QTcF) \\> 450 msec at time of screening\n* Clinically significant ventricular arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)\n* Uncontrolled intercurrent illness including, but not limited to, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 2 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure\n* Patients with uncontrolled infection will not be enrolled until infection is treated and under control per the principal investigator or their designee\n* Any psychiatric illness that prevents patient from informed consent process\n* Pregnant or breastfeeding at the time of enrollment\n* Patient has a malabsorption syndrome or other condition that precludes an enteral route of administration\n* Patient has history of a cardiovascular, endocrinologic, hepatic, immunologic metabolic, neurologic, psychiatric, pulmonary, renal disease, or any other condition that in the opinion of the investigator would adversely affect his\u002Fher participation in this study or interpretation of study results","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and\u002For effective in treating patients with relapsed\u002Frefractory FLT3 mutated acute myeloid leukemia.",[26,27,28,29,30],"Acute Myeloid Leukemia With FLT3\u002FITD Mutation","Acute Myeloid Leukemia With KMT2A Rearrangement","Acute Myeloid Leukemia With NPM1 Mutation","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","RECRUITING","2026-05-12",{"date":34,"type":35},"2026-05-14","ACTUAL",{"date":37,"type":35},"2024-02-20",{"date":39,"type":20},"2027-02-28",{"name":41,"class":42},"Uma Borate","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100441147","phase-1-vyxeos-plus-gilteritinib-in-relapsed-or-refractory-flt3-mutated-aml-100441147","NCT05024552","Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML","A Phase 1 Study of Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* FLT3-ITD or FLT3-TKD mutated AML (non-M3) in 1st or greater relapse or refractory to at least one prior line of AML directed therapy\n* FLT3 testing must be confirmed at the time of disease relapse\n* Adequate organ function\n* Left ventricular ejection fraction (LVEF) ≥50%\n* Prior anthracycline exposure ≤368 mg\u002Fm2 daunorubicin (or equivalent)\n* Ability to take oral medication and willingness to adhere to the medication regimen\n* For females of reproductive potential: use of highly effective contraception including double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices and tubal ligation.\n* For females of reproductive potential: negative serum or urine pregnancy test with a sensitivity of at least 50mIU\u002FmL within 10 days and again within 24 hours of beginning study treatment\n* For males of reproductive potential: use of condoms\n* Breastfeeding mothers must agree to discontinue nursing\n* Patients who have relapsed after and allogeneic stem cell transplant must have controlled grade ≤2 GVHD. Immunosuppression with tacrolimus or sirolimus is allowed at stable or tapering doses.\n\nExclusion Criteria:\n\n* Patients may not be receiving any other investigational agents\n* Patients with documented central nervous system involvement of AML\n* Progression of AML while on prior gilteritinib therapy\n* Patients must not have evidence of GI tract abnormalities that would alter the absorption of oral medications\n* Major surgery within two weeks of first dose of study drug. Patients must have recovered from the effects of any surgery performed greater than two weeks prior\n* WBC count ≥50,000 at the time study treatment begins. Use of hydroxyurea to maintain WBC \\\u003C50,000 is allowed up to the time that study treatment begins\n* Predicted inability to tolerate standard induction chemotherapy\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* No other malignancies in addition to AML that are currently requiring treatment with the exception of: 1) basal cell or squamous cell carcinoma or the skin; 2) carcinoma in situ of the cervix or breast; 3) a history of breast cancer that is currently being managed with adjuvant endocrine therapy\n* Grade ≥3 acute or chronic graft versus host disease after allogeneic stem cell transplant. No steroids for GVHD are allowed.",{"count":51,"type":20},22,[23],"This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy. Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allowed to proceed to consolidation therapy with vyxeos and gilteritinib. Those patients who do not proceed to an allogeneic stem cell transplant for any reason are able to enter the maintenance phase of this trial using daily gilteritinib",[26],"2025-12-04",{"date":57,"type":35},"2025-12-05",{"date":59,"type":35},"2022-02-25",{"date":61,"type":20},"2027-03",{"name":63,"class":42},"H. Lee Moffitt Cancer Center and Research Institute",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":64},"100605407","phase-1-a-study-to-evaluate-the-effect-of-xy0206-on-the-qtc-interval-in-chinese-healthy-participants-100605407","NCT07162116","A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants","A Single-center, Randomized, Double-blind, Placebo- and Positive Drug (Open-label Design) Controlled Phase I Clinical Study to Evaluate the Effect of a Single Oral Dose of XY0206 Tablets on QTc Interval in Healthy Chinese Participants.","XY0206-CQT","Inclusion Criteria:\n\n1. Participants voluntarily sign a written informed consent form.\n2. Male or female; aged between 18 and 45 years old (inclusive).\n3. Male participants weigh ≥ 50kg, female participants weigh ≥ 45kg, and their body mass index (BMI) is between 19.0 and 26.0 kg\u002Fm², inclusive.\n4. Physical examination, laboratory tests, and all trial-related examinations (vital signs, electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, etc.) at the screening stage are normal or have only minor abnormalities without clinical significance, and are deemed qualified by the clinical research doctor.\n5. Participants can communicate well with the researchers and comply with the protocol requirements to complete the study.\n\nExclusion Criteria:\n\nMedical history, past medical history, recent medication history:\n\n1. Those with a history of severe systemic diseases (including cardiovascular, digestive, urinary, respiratory systems, etc.), mental disorders, or drug dependence;\n2. Those with a history of drug or food allergies, or specific allergies (such as asthma, urticaria, eczema, etc.); or those allergic to XY0206 tablets, moxifloxacin hydrochloride, or other fluoroquinolones, or the excipients contained therein; or those known to be allergic to FLT3 inhibitors;\n3. Those with a history of difficulty swallowing or any gastrointestinal diseases (or gastrointestinal resection, etc.) that affect drug absorption;\n4. Those with hemorrhoids or perianal diseases with regular\u002Fongoing bleeding, irritable bowel syndrome, inflammatory bowel disease; or those with habitual constipation or diarrhea;\n5. Those with a history of pancreatitis;\n6. Those who have undergone major surgery within 6 months before screening or whose surgical incisions have not fully healed; major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia, or incisional biopsies or significant traumatic injuries;\n7. Those who have donated blood within 3 months before screening, or plan to donate blood during this study, or have received blood transfusions or lost ≥200ml of blood within 4 weeks before screening;\n8. Those who have participated in 4 or more clinical trials within the past year; or those who have participated in any clinical trials and received investigational drugs or devices within 3 months before this trial;\n9. Those with a history of drug abuse within the past 5 years or have used drugs within 3 months before the trial;\n10. Those who have taken any prescription drugs, over-the-counter drugs, vitamin products, health supplements, or herbal medicines within 4 weeks before screening or within 5 half-lives (if known), whichever is longer; or those who have taken any drugs known to cause QT\u002FQTc interval prolongation or have a risk of causing torsades de pointes (TdP) within 4 weeks before screening;\n11. Those with a history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia;\n12. Those who have received vaccinations within 3 months before screening or plan to receive vaccinations during this study;\n13. Those with a history of fainting at the sight of blood or needles and cannot tolerate venous catheterization;\n\n    Health status:\n14. Those with neurological, mental, respiratory, cardiovascular, digestive, hematological and lymphatic, endocrine, musculoskeletal, urinary, or any other diseases or physiological conditions that may affect the study results at the time of screening;\n15. Those with a history of cardiovascular diseases or risk factors for torsades de pointes (TdP) at the time of screening, including but not limited to: unexplained syncope; heart failure; myocardial infarction; angina pectoris; atrial fibrillation, atrial flutter, atrial premature beats, ventricular premature beats, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; long QT syndrome (LQTS) personal or family history; or a family history of sudden death;\n16. Those with 12-lead electrocardiogram results exceeding the standard at the screening or baseline period: PR \\> 200ms, QRS \\> 110ms, HR \\\u003C 50 bpm, QTcF \\> 450 ms (for both males and females); or those with abnormal electrocardiograms and the investigator deems the abnormalities clinically significant (such as atrioventricular block, potential bundle branch block, torsades de pointes (TdP), other types of ventricular tachycardia, ventricular fibrillation and ventricular flutter, clinically significant T-wave changes, or any 12-lead electrocardiogram results that may affect the QTc interval);\n17. Those with laboratory test results meeting the following abnormal ranges at the screening or baseline period:\n\n    a. Abnormal hematological indicators: i. White blood cells \\\u003C lower limit of normal (LLN); ii. Absolute neutrophil count \\\u003C LLN; iii. Platelet count \\\u003C LLN; iv. Hemoglobin \\\u003C LLN. b. Abnormal liver function: AST and\u002For ALT \\> upper limit of normal (ULN), total bilirubin and\u002For direct bilirubin \\> ULN; c. Creatinine \\> ULN, creatine kinase \\> ULN, creatine kinase isoenzyme \\> ULN, lipase \\> ULN, amylase \\> ULN; d. Metabolic abnormalities: serum triglycerides \\> 1.2 times ULN.\n18. Participants with positive hepatitis B surface antigen and\u002For hepatitis B e antigen, positive hepatitis C antibody, positive human immunodeficiency virus antibody, or positive Treponema pallidum antibody during the screening period;\n19. Participants with positive breath alcohol test or positive urine drug abuse screening at baseline;\n\n    Lifestyle restrictions:\n20. Participants with special dietary requirements who cannot adhere to the diet and corresponding regulations provided by the clinical research institution;\n21. Participants who cannot control special diets (including pitaya, mango, grapefruit and\u002For xanthine diet, caffeine-containing foods or beverages, strong tea, etc.) during the trial;\n22. Participants who have consumed special diets (including pitaya, mango, grapefruit and\u002For xanthine diet, caffeine-containing foods or beverages, strong tea, etc.) or engaged in vigorous exercise within 48 hours before administration, or have other factors that may affect drug absorption, distribution, metabolism, and excretion;\n23. Participants who have consumed alcohol frequently in the 6 months prior to administration, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or cannot stop alcohol intake during the trial;\n24. Participants who smoke more than 5 cigarettes per day in the 3 months prior to administration, or will use any tobacco products during the trial;\n\n    Contraception:\n25. Pregnant or lactating women or those with positive pregnancy tests;\n26. Participants who have used oral contraceptives within 30 days before screening (applicable to females only);\n27. Participants who have used long-acting estrogen or progesterone injections or implants within 6 months before screening (applicable to females only);\n28. Females of childbearing age who have had unprotected sexual intercourse with their partners within 14 days before screening;\n29. Participants of childbearing age, male or female, who have a plan to conceive from the time of signing the informed consent form until one year after the end of the trial, or who do not agree to use effective contraceptive methods, or do not agree to avoid freezing or donating sperm\u002Feggs.\n\n    Other criteria:\n30. Participants who are considered to have poor compliance or have any other factors that make them unsuitable for this trial by the investigator;\n31. The investigator, their family members, and related personnel of the research center;\n32. Students and subordinates of the investigator, employees of the sponsor, and other vulnerable participants;\n33. Participants who may be unable to complete the study for other reasons.",true,"45 Years",{"count":76,"type":20},45,[23],"This study plans to enroll 45 (Groups A, B, and C) to 75 healthy participants (including the sample size of other potential dose groups). The participants will be divided into three dose groups: 37.5 mg, 75 mg, and 150 mg. After taking the corresponding investigational product, participants are required to complete test procedures including QTc interval measurement , blood sampling, and vital sign monitoring. The entire test process lasts for 3 days. On the third day, after participants complete laboratory tests and are assessed by physicians as meeting the discharge criteria, they can be discharged.",[26],"2025-09-07",{"date":82,"type":35},"2025-09-09",{"date":84,"type":35},"2025-07-06",{"date":86,"type":20},"2026-05",{"name":88,"class":89},"Shijiazhuang Yiling Pharmaceutical Co. Ltd","INDUSTRY",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100506626","phase-3-a-study-of-xy0206-versus-salvage-chemotherapy-in-patients-with-relapsed-or-refractory-aml-with-flt3-itd-mutation-alive-100506626","NCT05876832","A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE)","Phase 3 Open-label, Multicenter, Randomized Study of XY0206 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3(FLT3)-Internal Tandem Duplication（ITD） Mutation","Inclusion Criteria:\n\n1. Age≥18 years old.\n2. Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization (WHO) classification as determined by pathology review at the treating institution.\n3. Subject is refractory to or relapsed after prior AML therapy (with or without hematopoietic stem cell transplant ):\n\n   * Advanced relapse after first-line AML therapy is defined as: the patients achieved Complete remission without minor residual diseases\u002Fcomplete remission\u002Fcomplete remission with partial hematologic recovery\u002Fcomplete remission with incomplete hematologic recovery\u002Fcomplete remission with incomplete platelet recovery\u002FMorphologic leukemia- free state(CRMRD-\u002FCR\u002FCRh\u002FCRi\u002FCRp\u002FMLFS )after first-line treatment and relapsed after 12 months with hematological relapse;\n   * Patients with relapsed \u002F refractory AML.\n   * Refractory to first-line AML therapy is defined as:the patient did not achieve CRMRD-\u002FCR\u002FCRh\u002FCRi\u002FCRp\u002FMLFS under initial therapy.A subject eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A subject not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject.\n   * Early relapse:Relapse within 12 months after consolidation therapy after achieving CRMRD-\u002FCR\u002FCRh\u002FCRi\u002FCRp\u002FMLFS.\n   * Relapse after 12 months but nonresponse to conventional chemotherapy after achieving CRMRD-\u002FCR\u002FCRh\u002FCRi\u002FCRp\u002FMLFS.\n   * Second or more relapse.\n   * Patients who cannot tolerate intensive chemotherapy develop disease progression during continuous treatment with low-intensity drugs.\n   * Persistence of extramedullary leukemia.\n4. Patient is positive for FLT3-ITD mutation in bone marrow or whole blood.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n6. Expected survival ≥12 weeks .\n7. Patient must meet the following criteria as indicated on the clinical laboratory tests:\n\n   * Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of ≥50 mL\u002Fmin .\n   * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)\n   * Serum total bilirubin (TBL) ≤ 1.5 x ULN.\n   * Fridericia's Heart Rate Correction Formula (QTcF) interval ≤480 msec.\n8. Female patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to the first study drug administration.Female patients of childbearing potential and male must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug.\n9. The subject should be willing to provide evidence of valid diagnosis before treatment or undergo bone marrow puncture or biopsy for diagnosis, and receive bone marrow puncture or biopsy for efficacy evaluation after treatment.\n10. Patients volunteered to participate in this study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patient was diagnosed as acute promyelocytic leukemia (APL), or Philadelphia chromosome（BCR-ABL）-positive leukemia (chronic myelogenous leukemia in blast crisis).\n2. Patients who received live vaccine (including live attenuated vaccine) within 4 weeks before randomization and\u002For planed to receive live vaccine after enrollment.\n3. Presence of FLT3-tyrosine kinase domain(TKD) mutation.\n4. Patients were prior failed adequate treatment with FLT3 inhibitors.\n5. AML with Central Nervous System Leukemia.\n6. Patient has AML secondary to prior chemotherapy for other neoplasms, except for MDS.\n7. Patients with other malignant tumors past or present,unless whose Disease-free survival period≥5 years.Non-melanin skin cancer, carcinoma in situ, or cervical intraepithelial neoplastic lesions with completed radical treatment (regardless of disease-free survival),and subjects with prostate cancer confined to the prostate and with no evidence of disease recurrence or progression,if they have started hormonal therapy or have undergone surgery to remove the malignancy or have undergone radical radiotherapy,will be eligible for the study.\n8. Pretrial treatment conditions:\n\n   * Patients who received hematopoietic stem cell transplantation within the 2 months before enrollment,or having clinically significant graft-versus-host disease (GVHD) or receiving systemic cortisol hormone therapy for GVHD.\n   * Patients who received chemotherapy, biological therapy, targeted anti-tumor therapy within 14 days before the first use of the drug in this study or within 5 half-lives of the drug, or radiation therapy within 28 days.\n   * Patients who participated in other clinical trials and received trial drugs within 28 days to the first study dose.\n   * Patients who have had major surgery or significant traumatic injury within 28 days to the first study dose or planted to require major surgery during study treatment.\n9. Concurrent disease conditions:\n\n   * Patients are hepatitis B surface antigen or core antibody actives positive,and hepatitis B virus(HBV) DNA ≥2000IU\u002FmL or 1×104 copy\u002FmL.\n   * Patients are hepatitis C virus (HCV) antibody actives positive and HCV-RNA quantification is above the upper limit of normal at each center.\n   * Human immunodeficiency virus (HIV) seropositivity.\n   * Patient has clinically obvious gastrointestinal abnormalities that may affect the intake, transport, or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc),patients with total gastrectomy or major gastrectomy (Billroth II), patients with a clear gastrointestinal bleeding tendency,or major gastrointestinal bleeding considered possible by the investigator.\n   * Patient has uncontrolled epilepsy history.\n   * Patient has uncontrolled hypertension defined as systolic blood pressure greater than 160 mmHg or diastolic pressure greater than 100 mmHg, despite optimal medical management and optimal measurement.\n   * Patient has clinically significant abnormal serum lipase or amylase indicators during screening.\n   * Patient has refractory intractable hypokalemia or hypomagnesemia.\n   * Patient has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation (DIC), hemophilia.\n   * Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 1 month before study entry results in a left ventricular ejection fraction that is ≥ 45%.\n   * Patients with second degree (Mobitz II) or third degree atrioventricular block disease (except for patients who use the pacemaker) or complete left bundle branch block.\n   * Patients with new clinically significant arrhythmias (except for sinus tachycardia caused by anemia, infection and AML) or patients with previous arrhythmias that require long-term use of drugs with QT-prolonging effects.\n   * Patients with any one of the following diseases within 6 months prior to randomization:myocardial infarction,unstable angina pectoris,Patients undergoing coronary artery bypass graft(CABG) or peripheral artery bypass implantation,congestive heart-failure,Cerebrovascular events (including cerebral hemorrhage and cerebral infarction, etc.),Deep venous thrombosis (except for deep venous thrombosis due to peripherally inserted central venous catheter (PICC) catheterization),pulmonary embolism and other diseases that the researcher considers inappropriate to participate in this study.\n   * Patients with diagnosed or suspected long QT syndrome at screening (including a family history of long QT syndrome).\n   * Patient has an active uncontrolled infection.\n   * Patient has severe unhealed wounds, ulcers, or fractures.\n   * Females who are pregnant or breastfeeding.\n   * Patients are not suitable for the study in the investigator's opinion.",{"count":98,"type":20},312,[100],"PHASE3","The purpose of this study is to determine the clinical benefit of XY0206 therapy in participants with FLT3-ITD mutated AML who are refractory to or have relapsed after prior AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study is also to investigate the efficacy of XY0206 as assessed by CR\u002FCRh rate in these subjects。",[26],"NOT_YET_RECRUITING","2023-05-24",{"date":106,"type":35},"2023-05-26",{"date":108,"type":20},"2023-06-15",{"date":110,"type":20},"2027-07-01",{"name":88,"class":89}]