[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelodysplastic-syndromeacute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelodysplastic-syndromeacute-myeloid-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,71],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100543539","phase-1-iadademstat-in-combination-with-azacitidine-and-venetoclax-in-treating-newly-diagnosed-acute-myeloid-leukemia-100543539",false,"NCT06357182","Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia","A Phase Ib Investigation of the LSD1 Inhibitor Iadademstat (ORY-1001) in Combination With Azacitidine and Venetoclax in Newly Diagnosed AML","Inclusion Criteria:\n\n* Patients at least 18 years of age will be considered for inclusion without bias against gender identity, race, or ethnicity\n* Ability to comprehend the investigational nature of the study and provide written informed consent\n* Patients with previously untreated, morphologically documented AML based on World Health Organization (WHO) 2008 definitions who are ineligible for standard of care (SOC) intensive chemotherapy (IC) induction OR documented unwillingness to undergo IC induction. Ineligible for IC is defined as:\n\n  * Documented intermediate- or adverse-risk AML based on European Leukemia Network (ELN) 2022 criteria\n  * Note: Cases of AML (MDS) overlap with 10-19% bone marrow (BM) or peripheral blood (PB) blasts will be considered\n  * Note: Cases of acute promyelocytic leukemia (PML) and AML with BCR::ABL1 fusions will be excluded\n* Eastern Cooperative Oncology Group (ECOG) performance ≤ 2 (Patients aged ≥ 75 years, at the time of consent)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Patients aged ≥ 75 years, at the time of consent)\n\n  * High total bilirubin values may require indirect and direct bilirubin testing. Individuals with known Gilbert's syndrome may be considered for enrollment despite high indirect (and total) bilirubin\n* Creatinine clearance (CrCl) of ≥ 60 mL\u002Fmin (estimated using the Cockcroft Gault formula or measured by 24 hours urine collection. If altered, CrCl is determined to be related to concomitant medication that alters renal function\n* Patients aged ≥ 18 to 74 years (ECOG performance status \\[PS\\] ≤ 3 is accepted) at consent must meet ≥ 1 of the following criteria defining a co morbidity:\n\n  * ECOG PS of 2 or 3 (Note: Patients ≥ 18 to 74 years of age with PS of 0-1 must meet criteria of one of the following comorbidities.)\n  * Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina\n  * Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%\n  * CrCl ≥ 30 mL\u002Fmin to \\\u003C 45 ml\u002Fmin\n  * Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0 × ULN;\n\n    * High total bilirubin values may require indirect and direct bilirubin testing. Individuals with known Gilbert's syndrome may be considered for enrollment despite high indirect (and total) bilirubin\n  * Other comorbidities that the physician judges to be incompatible with intensive chemotherapy (IC). In these cases, the comorbidity must be reviewed and approved by the principal investigator (PI) before study enrollment\n* Ability to swallow oral medications\n* No ongoing anticoagulation or antiplatelet therapy within 14 days of start of treatment with IADA\n* No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* No history of stroke or intracranial hemorrhage within 180 days of start of IADA\n* No major bleeding event, as defined by the International Society of Thrombosis and Hemostasis (ISTH), within 12 weeks of start of IADA\n* Uncorrected international normalized ratio (INR) or activated partial thromboplastin time (aPTT) of \\\u003C 1.5 x ULN.\n\n  * If INR or aPTT \\> 1.5 x ULN has been corrected (prior to enrollment), then history of disseminated intravascular coagulation (DIC) must be absent\n* White blood cell (WBC) \\\u003C 20 x 10\\^9\u002FL prior to study start. Cytoreduction prior to study treatment is allowed with\n\n  * Hydroxyurea for up to 14 days and until 24 hours prior to start of IADA; or\n  * Leukapheresis for up to 14 days prior to start of IADA\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 2.0 x institutional ULN\n\n  * Lower hepatic function may be considered if liver enzyme abnormalities are determined by the treating MD and principal investigator (PI) to be due to leukemic infiltration\n* Willing and able to\n\n  * Adhere to study schedule of activities and life style restrictions while on treatment;\n  * Provide bone marrow (BM) aspirate and core biopsy samples; and\n  * Accept supportive and prophylactic care for hematologic toxicities, infection, and immediate sequelae, including transfusions\n* Negative pregnancy test within 72 hours of start of IADA for persons of childbearing potential (PCBP)\n* Willingness to comply with study requirements for contraception, as follows: PCBP and sperm-producing participants who are sexually active with a PCBP must use study approved contraception from start of investigational product (first dose of IADA) until 6 months after the last dose of IADA. Pregnancy is exclusionary because the agents used in this study have the potential for teratogenic or abortifacient effects\n\nExclusion Criteria:\n\n* Prior allergic response to iadademstat (IADA), venetoclax, azacitidine, or any excipients in the formulations\n* Body weight \\\u003C 50 kg\n* Investigational therapy within 5 half-lives or, if unknown, within 28 days prior to start of IADA\n* Treatment for AML within 14 days prior to start of IADA. Cytoreduction for patients with proliferative disease must meet the criteria listed in inclusion criteria\n* Radiotherapy less than 14 days prior to start of IADA\n* Recent and significant medical interventions, such as major surgery within 28 days prior to the start of IADA, or stem cell transplant within 100 days prior to the start of IADA. Patients with active treatment for graft-versus-host disease (GVHD) are excluded\n* Another active malignancy within 5 years prior to the start of IADA, or at the investigator's discretion\n* Treatments targeting or inhibiting LSD1\u002FKDM1A or BCL 2 within 12 months prior to the start of IADA\n* Documented dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally\n* Treatment with monoamine oxidase inhibitors (e.g., tranylcypromine), if treatment is not finalized at least 3 weeks prior to the start of IADA\n* Active central nervous system involvement with AML\n* Uncontrolled infection. Participants with controlled infection must be afebrile and hemodynamically stable for at least 72 hours prior to start of IADA and must be amenable to alternate treatment if current treatment will interact with investigational regimen\n* Active hepatic disorder or documented positive hepatitis B or C virus (HBV\u002FHCV, respectively) status, except in cases of undetectable HBV\u002FHCV viral load for at least 3 months prior to the start of IADA. (Hepatitis B or C testing is not required for eligibility assessment.)\n* Individuals serology positive for human immunodeficiency virus (HIV) and under active treatment with highly active antiretroviral therapy (HAART) (or another therapy that may interfere with metabolism of study agents). Otherwise, enrollment may be considered in cases of HIV that is controlled with another treatment type or in cases that that acceptable modification of the patient's HIV treatment exists\n* Use a P-gp inhibitor within 21 days or 3 half-lives whichever is longer prior to treatment with venetoclax\n* Use of strong or moderate CYP3A4 inducers or inhibitors within 2 days or 3 half lives whichever is longer, prior to start of treatment with venetoclax\n* Unwillingness to stop breastfeeding. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided throughout the study and until at least 60 days after last dose of IADA\n* Uncontrolled hypertension (i.e., systolic blood pressure \\> 180 mm Hg, diastolic blood pressure \\> 95 mm Hg). Use of anti-hypertensive agents to control hypertension before C1D1 is allowed\n* Patients with poorly controlled diabetes. Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) ≥ 8%; patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion\u002Fexclusion criteria are met\n* Patients with mean of triplicate corrected QT interval (Fridericia's correction formula \\[QTcF\\]) \\> 450 ms at Screening based on central reading\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, unstable cardiac or pulmonary function or acute insufficiency (e.g., symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia), or psychiatric illness or social situation that could limit compliance with study requirements, at the discretion of the investigator","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 iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as azacitidine, 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. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe, tolerable and\u002For effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy.",[26,27],"Acute Myeloid Leukemia","Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","RECRUITING","2026-06-28",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":32},"2024-08-22",{"date":36,"type":20},"2028-05-29",{"name":38,"class":39},"OHSU Knight Cancer Institute","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100553282","phase-1-testing-the-anti-cancer-drug-cirtuvivint-and-its-combination-with-astx727-to-improve-outcomes-in-patients-with-acute-myeloid-leukemia-and-myelodysplastic-syndromes-100553282","NCT06484062","Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes","A Phase I Study Evaluating the Safety of Cirtuvivint as Monotherapy and in Combination With ASTX727 in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* In Cohorts I and II, patients must have R\u002FR AML or MDS (venetoclax naïve or venetoclax exposed)\n\n  * Relapsed AML is defined as the appearance of 5% or greater myeloblasts in the bone marrow or peripheral blood after achieving a complete remission (CR), CR with partial hematologic recovery (CRh), or CR with incomplete hematologic recovery (CRi). Patients with a mutation in FLT3, IDH1 or IDH2 must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved FLT3, IDH1 or IDH2 inhibitor before enrolling on study. The initial diagnosis of AML is defined by the ELN 2022 criteria, and therefore patients with either AML (peripheral blood or bone marrow blasts ≥ 20% or blasts ≥ 10% with recurrent genetic abnormalities) or MDS\u002FAML (peripheral blood or bone marrow blasts 10-19%) are eligible\n  * Refractory AML is defined as failure to achieve a CR, CRh, or CRi after one of the following regimens: (i) ≥ 2 cycles of intensive induction chemotherapy with a cytarabine containing regimen (e.g., 7+3, mitoxantrone, etoposide, cytarabine \\[MEC\\], high-dose cytarabine \\[HIDAC\\], reinduction chemotherapy such as 5 + 2, etc.) or, (ii) ≥ 2 cycles of hypomethylating agent (HMA)\u002Fvenetoclax or low-dose cytarabine (LDAC)\u002Fglasdegib or, (iii) ≥ 4 cycles of HMA monotherapy. The initial diagnosis of AML is defined by the ELN 2022 criteria, and therefore patients with either AML (peripheral blood or bone marrow blasts ≥ 20% or blasts ≥ 10% with recurrent genetic abnormalities) or MDS\u002FAML (peripheral blood or bone marrow blasts 10-19%) are eligible\n  * Patients with MDS\u002FAML (blasts 10-19%) who progress to AML (blasts ≥ 20%) after treatment will be considered relapsed or refractory MDS\u002FAML, and not as newly-diagnosed AML (i.e. the patients' treatment history for eligibility purposes does not reset)\n  * Relapsed MDS is defined as: (i) Intermediate, high, or very high-risk disease by International Prognostic Scoring System-Revised (IPSS-R) and, (ii) Any relapse after achieving any 2023 IWG MDS defined response\n  * Refractory MDS is defined as: (i) Intermediate, high, or very high-risk disease by IPSS-R and \\> 5% blasts in the bone marrow or peripheral blood, (ii) Failure to achieve a response (as per IWG 2006 criteria) after ≥ 4 cycles of HMA monotherapy, or (iii) ≥ 2 cycles of HMA + venetoclax\n* In Cohort III, patients must have prior untreated high-risk MDS\n\n  * MDS with \\> 5% blasts in the bone marrow or peripheral blood AND\n  * IPSS-R high or very high-risk disease OR\n  * Molecular International Prognostic Scoring System (IPSS-M) high or very high-risk disease\n  * No more than one single prior cycle of DNMTi therapy\n  * Prior use of erythropoiesis stimulating agents (ESA), thrombopoietin agonists, lenalidomide, and luspatercept are allowed\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of SM08502 (cirtuvivint) in combination with ASTX727 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; in that case a cut off of ≤ 4 × institutional ULN will be used)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (unless considered due to organ involvement by the patient's myeloid malignancy; in that case a cut off of ≤ 5 x institutional ULN will be used)\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin\u002F1.73m\\^2\n* If female, patient must be either:\n\n  * Postmenopausal (surgically sterile or age \\> 55 years with no menses for 12 or more months without an alternative medical cause or age equal to 55 or less with no menses for 12 or more months without an alternative medical cause and a follicle stimulating hormone \\[FSH\\] level \\> 40 IU\u002FL); or\n  * Of children bearing potential. These patients 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. 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. Patient must agree to have a negative urine or serum beta-human chorionic gonadotropin (HCG) test result during screening and repeated within 7 days prior to study drug (local labs are allowed) to be eligible\n* The effects of SM08502 (cirtuvivint) and ASTX727 on the developing human fetus are unknown. For this reason, and because these agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and during the treatment therapy. Women of childbearing age should agree to use adequate contraception for 7 months after completion of SM08502 (cirtuvivint) administration. For ASTX727, adequate contraception must continue for at least 6 months after last dose of ASTX727. 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of the study and at least 4 months after the last dose of SM08502 (cirtuvivint) and 3 months after last dose of ASTX727. Women who are lactating must refrain from breastfeed during the study and at least for two weeks after last dose of ASTX727\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia or abnormal blood counts\n* Patients who are receiving any other investigational agents\n* Systemic anti-leukemic or other antineoplastic therapy within 14 days of first day of study treatment. Hydroxyurea may be continued through cycle 1 of treatment. Hydroxyurea is discouraged in subsequent cycles and should be discussed beforehand with principal investigator. If on venetoclax, then a wash-out period of at least five times the half-life of venetoclax is required. Exceptions: No wash-out required for intrathecal chemotherapy, hydroxyurea, cytarabine (Ara-C), or palliative radiation therapy to painful sites of leukemic disease. Patients are not allowed to receive concurrent therapy such as cytotoxic chemotherapy or radiation therapy for another cancer. Patients on hormonal adjuvant therapy for non-metastatic breast and prostate cancer or other minimally-myelosuppressive maintenance therapies for non-metastatic cancer may be eligible at the discretion of the study principal investigator (PI)\n* Patient is receiving known inhibitors or activators of flavin-containing monooxygenases (FMO1 or FMO3), and these cannot be stopped at least 5 days prior to SM08502 (cirtuvivint) treatment start. Known inhibitors of FOMO are chlorpromazine and imipramine\n* Patient is receiving strong inhibitors or strong inducers of CYP3A4\u002F5 and these cannot be stopped at least 5 days prior to SM08502 (cirtuvivint) treatment start\n\n  * Strong inhibitors include grapefruit juice or grapefruit\u002Fgrapefruit related citrus fruits (e.g., Seville oranges, pomelos), ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir, nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n  * Strong inducers include phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, clevidipine, and St. John's Wort. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance.\n  * While moderate inhibitors or moderate inducers of CYP3A4\u002F5 are not an exclusion criteria for the trial, it is preferred that moderate inhibitors or moderate inducers of CYP3A4\u002F5 be replaced prior to the first dose of SM08502 (cirtuvivint) and during study conduct where this is possible.\n\n    * Moderate inhibitors include erythromycin, ciprofloxacin, verapamil, diltiazem, atazanavir, fluconazole, darunavir, delavirdine, amprenavir, fosamprenavir, aprepitant, imatinib, tofisopam, and cimetidine. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n    * Moderate inducers include bosentan, efavirenz, etravirine, modafinil, and nafcillin. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SM08502 (cirtuvivint) or ASTX727\n* Chronic, active hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: patients with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative, anti-HBs antibody positive and anti-hepatitis B core \\[HBc\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. Patients who had prior HCV that has been definitively treated with negative HCV viral load prior to study initiation and no evidence of cirrhosis, are allowed to participate. If there is no known history of HBV infection no HBV studies need to be obtained. If there is no known history of HCV infection, no HCV studies need to be obtained\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant and lactating women are excluded from this study because SM08502 (cirtuvivint) is a small molecule inhibitor of CLK DYRK with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SM08502 (cirtuvivint), breastfeeding should be discontinued if the mother is treated with SM08502 (cirtuvivint). These potential risks may also apply to other agents used in this study\n* Patients with acute promyelocytic leukemia\n* Subject has symptomatic central nervous system (CNS) involvement with AML\n* Patient has immediate life-threatening, severe complications of their myeloid malignancy such as uncontrolled bleeding and\u002For uncontrolled infection\n* Patient has significant active cardiac disease within 6 months prior to the start of study treatment, including uncontrolled New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke\n* Left ventricular ejection fraction (LVEF) \\\u003C 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 30 days prior to the start of study treatment\n* Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. Patient needs to be able to swallow pills\n* Patient has 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* Subject has prolonged corrected QC (QTc) interval (Fridericia's correction \\[QTcF\\]) ≥ 480 ms or known family history of long QT interval syndrome at screening",{"count":49,"type":20},54,[23],"This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Giving cirtuvivint alone or in combination with ASTX727 may be safe, tolerable, and\u002For effective in treating patients with AML and MDS.",[26,53,27,54,55,56,57,58,59],"Myelodysplastic Syndrome","Recurrent Acute Myeloid Leukemia","Recurrent Myelodysplastic Syndrome","Recurrent Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","Refractory Myelodysplastic Syndrome","Refractory Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","2026-06-10",{"date":62,"type":32},"2026-06-11",{"date":64,"type":32},"2025-08-15",{"date":66,"type":20},"2028-06-01",{"name":68,"class":69},"National Cancer Institute (NCI)","NIH",22,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":16,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100345603","phase-2-naive-t-cell-depletion-for-preventing-chronic-graft-versus-host-disease-in-children-and-young-adults-with-blood-cancers-undergoing-donor-stem-cell-transplant-100345603","NCT03779854","Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant","Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults","Inclusion Criteria:\n\n* The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal investigator (PI):\n\n  * Acute lymphoblastic leukemia (ALL) with \\\u003C 5% marrow blasts.\n  * Acute myeloid leukemia (AML) with \\\u003C 25% marrow blasts.\n  * Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia \\[ABL\\], ambiguous lineage \\[ALAL\\], mixed phenotype acute leukemia \\[MPAL\\], blastic plasmacytoid dendritic cell neoplasm \\[BPDCN\\], acute undifferentiated leukemia \\[AUL\\], lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia, chronic monocytic leukemia \\[CML\\] with blast crisis or other chronic myeloproliferative neoplasm) with \\\u003C 5% marrow blasts.\n  * Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents)\n* Age 6 months to 26 years at the time informed consent is obtained using the Informed Consent to Participate in a Research Study form\n* Matched related donor (MRD) or matched unrelated donor (MUD) (defined as 8\u002F8 match for human leukocyte antigen \\[HLA\\]-A, -B, -C, -DRB1).\n* Planned product type for infusion is PBSC or BM (i.e. not cord blood):\n\n  * For feasibility phase, planned product type for infusion must be PBSC.\n  * For RCT, planned product type must be PBSC or BM.\n* Karnofsky or Lansky score \\>= 60%.\n* Left ventricular ejection fraction (LVEF) at rest \\>= 40%.\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) \\>= 60% predicted by pulmonary function tests (PFTs)\n\n  \\* Patients who are unable to perform PFTs (age \\\u003C 6 years or considered developmentally incapable of PFTs): oxygen saturation (by oximetry) must be \\>= 92% on room air.\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal (GI) physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 2 x ULN (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal GI physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Serum creatinine (SCr) within normal range for age. If SCr is outside normal range for age, creatinine clearance (CrCl) \\> 40 mL\u002Fmin\u002F1.73m\\^2 must be obtained (measured by 24-hour \\[hr\\] urine specimen or nuclear glomerular filtration rate \\[GFR\\]).\n\n  * Age (Years): Maximum SCr (mg\u002FdL)\n  * =\\\u003C 5: 0.8\n  * 6-10: 1\n  * 11-15: 1.2\n  * \\> 15: 1.5\n* Recipient informed consent\u002Fassent\u002Flegal guardian permission documentation must be obtained.\n* DONOR: May be related (MRD) or unrelated (MUD) to the subject.\n* DONOR: Must be matched to the subject at 8\u002F8 HLA alleles (HLA-A, -B, -C, and -DRB1)\n* DONOR: Be \\>=14 years of age.\n* DONOR: Must be available to donate in the United States of America (USA) (i.e. excludes international donors).\n* DONOR: Must agree to donate BM or PBSC (i.e. agree to donate whichever product type is requested) (applicable only to the RCT phase of this study).\n* DONOR: MUDs:\n\n  * Must give informed consent according to applicable National Marrow Donor Program (NMDP) donor regulatory requirements\n  * Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii))\n\n    * Tests must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory\n* DONOR: MRDs:\n\n  * Must be negative for human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2, hepatitis B, hepatitis C (serological and\u002For nucleic acid testing \\[NAT\\] and\u002For other approved testing)\n  * Must meet institutional donor eligibility criteria, or be ineligible with statement that the donor is a first or second degree relative (exception 21 CRF 1271.65(b)(i)).\n\n    * Tests must be performed using FDA licensed, cleared, and approved test kits in a CLIA-certified laboratory.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen, a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.\n* Patients on other experimental protocols for the prevention of GVHD.\n* Patient body weight:\n\n  * Matched related donor (MRD): \\> 100 kg are ineligible\n  * Matched unrelated donor (MUD): \\> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.\n* HIV-positive.\n* Uncontrolled infections must be evaluated by an infectious disease physician and considered suitable to undergo HCT by the study site PI, infectious disease physician and protocol PI. Upper respiratory tract infection (URI) does not constitute an uncontrolled infection in this context.\n* Life expectancy \\\u003C 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS).\n* Significant medical condition that would make recipient unsuitable for HCT.\n* Prior allogeneic or autologous HCT.\n* Females who are pregnant or breastfeeding.\n* Patients of child bearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during study treatment and for 12 months following HCT.\n* Known hypersensitivity to tacrolimus, fludarabine, or methotrexate (MTX).",true,"6 Months","26 Years",{"count":82,"type":20},68,[84],"PHASE2","This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.",[87,88,89,90,91,92,93,94,95,96,97,27,98,99,100,101,102],"Acute Biphenotypic Leukemia","Acute Leukemia","Acute Leukemia of Ambiguous Lineage","Acute Lymphoblastic Leukemia","Acute Undifferentiated Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation Recipient","Blastic Plasmacytoid Dendritic Cell Neoplasm","Blasts Under 25 Percent of Bone Marrow Nucleated Cells","Blasts Under 5 Percent of Bone Marrow Nucleated Cells","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndrome With Excess Blasts-1","Burkitt Leukemia","Chronic Monocytic Leukemia","Lymphoblastic Lymphoma","Mast Cell Leukemia","Myeloproliferative Neoplasm","2026-05-11",{"date":105,"type":32},"2026-05-14",{"date":107,"type":32},"2019-08-29",{"date":109,"type":20},"2028-12-31",{"name":111,"class":39},"Fred Hutchinson Cancer Center",10]