[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-myelodysplastic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-myelodysplastic-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,71,96,125,162,182,215,246,279],{"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":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100639561","phase-1-atrn-119-in-combination-with-decitabine-in-patients-with-tp53-mutated-aml-or-higher-risk-mds-100639561","NCT07617363","ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS","A Phase I Study of ATRN-119, an ATR Inhibitor, in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS","Inclusion Criteria:\n\n* Diagnosis of AML or higher-risk MDS (HR-MDS) according to the World Health Organization (WHO) 5th Edition or International Consensus Classification (ICC) 2022 criteria.\n\n  * HR-MDS is defined as:\n  * IPSS-R (score \\> 3.5) or IPSS-M (score \\> 0.5) OR ii.≥ 10% bone marrow blasts\n* Dose Escalation ONLY - One of the following:\n\n  * Previously untreated AML with ELN 2022 adverse-risk genetic features based on local testing, in patients who are ineligible for intensive induction chemotherapy (cytarabine plus an anthracycline) due to age, comorbidities, or performance status.\n  * Previously untreated HR-MDS\n  * Relapsed or refractory AML or HR-MDS meeting one or more of the following criteria: Failure to achieve CR, CRh, or CRi after ≥ 4 cycles of a hypomethylating agent (HMA); Failure to achieve CR, CRh, or CRi after ≥ 2 cycles of a HMA plus venetoclax; Overt disease progression during HMA-based therapy; First relapse with an initial remission duration \\\u003C 12 months; First relapse following failed salvage chemotherapy; Relapse after allogeneic hematopoietic cell transplant; Second or subsequent relapse\n* Dose Expansion ONLY - Both of the following:\n\n  * AML or HR-MDS with a TP53 alteration, defined by the presence of any of the following features on local testing: Pathogenic or likely pathogenic TP53 mutation detected by molecular testing (with a minimum 2% VAF); Cytogenetic and\u002For FISH evidence of 17p deletion involving TP53 (with a minimum 2% cell involvement or the lower limit of detection of the assay); Increased hematopoietic p53 protein expression by immunohistochemistry (defined as \\>20% p53-positive cells). Patients enrolled during the dose expansion phase on the basis of increased p53 protein expression who are subsequently found not to harbor a TP53 mutation on molecular testing may continue study treatment.\n  * No prior therapy for a myeloid neoplasm, with the exception of permitted treatments\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate organ function within 28 days prior to the first dose of ATRN-119 as defined below:\n\n  * Total bilirubin ≤ 2.0 x IULN; patients with known or suspected Gilbert's syndrome may have total bilirubin ≤ 5 mg\u002FdL\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Estimated glomerular filtration rate (eGFR) \\> 30 mL\u002Fmin\u002F1.73 m2 or creatinine clearance ≥ 30 mL\u002Fmin\u002F1.73 m2 by Cockcroft-Gault formula or creatinine ≤ 2.0 x IULN\n* The effects of ATRN-119 and decitabine on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the last dose of ATRN-119 or decitabine on study (whichever is later) for people of childbearing potential and 3 months for people able to father a child.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Dose Expansion ONLY - Prior therapy for AML, HR-MDS, antecedent MDS, or antecedent myeloproliferative neoplasm (MPN) with the exception of erythropoiesis-stimulating agents, hematopoietic growth factors (e.g., G-CSF, thrombopoietin receptor agonists), hydroxyurea, luspatercept, imetelstat, all-trans retinoic acid (ATRA), and leukapheresis.\n* Active CNS involvement by AML requiring therapeutic intervention.\n* Active graft-versus-host disease (GVHD) requiring systemic immunosuppressive therapy except for low-dose steroids (prednisone ≤ 10 mg per day or other steroid equivalent)\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Currently receiving any other investigational agents.\n* Concomitant systemic treatment with strong inhibitors or inducers of CYP3A4. Patients may be eligible after a washout period of 5 half-lives or 28 days (whichever is shorter).\n* A history of allergic reactions attributed to or known hypersensitivity to compounds of similar chemical or biologic composition to ATRN-119, decitabine, or other agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, clinically significant autoimmune disease requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, or clinically significant or uncontrolled cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.\n* Conditions that may impair oral drug administration or absorption, including inability to swallow oral medications, malabsorption syndromes, or other clinically significant gastrointestinal disorders.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of Cycle 1 Day 1.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing is not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load by PCR on suppressive therapy are eligible. HBV testing is not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing is not required in the absence of known history of infection.",{"count":56,"type":20},27,[23],"This is a single-center, open-label, phase I study with dose escalation and dose expansion testing the combination of ATRN-119 and decitabine in patients with TP53-mutated acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS). The dose escalation phase will enroll patients with previously untreated, relapsed, or refractory AML or HR-MDS, regardless of TP53 alteration status, with the primary objective of determining safety and tolerability of ATRN-119 plus decitabine. The dose expansion phase will only enroll patients with previously untreated AML or HR-MDS with a TP53 alteration, with the primary objective of identifying the recommended phase 2 dose (RP2D).",[27,60],"High-risk Myelodysplastic Syndrome","NOT_YET_RECRUITING","2026-05-20",{"date":64,"type":39},"2026-06-01",{"date":66,"type":20},"2026-08-31",{"date":68,"type":20},"2031-12-31",{"name":70,"class":46},"Washington University School of Medicine",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":95,"locationsCount":47},"100331014","phase-2-dexrazoxane-hydrochloride-in-preventing-heart-related-side-effects-of-chemotherapy-in-participants-with-blood-cancers-100331014","NCT03589729","Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers","Cardioprotection With Dexrazoxane in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), Myeloid Blast Phase of Chronic Myeloid Leukemia (CML), Ph+ AML, and Myeloid Blast Phase of Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Baseline left ventricular ejection fraction (LVEF) is greater than or equal to 50% by echocardiography (echo) or multigated acquisition (MUGA) scan.\n* Patients of child bearing potential should use contraception.\n* Patients with a diagnosis of acute myeloid leukemia (AML), or high risk myelodysplastic syndrome (MDS) (\\>= 10% blasts or International Prognostic Scoring System \\[IPSS\\] \\>= intermediate-2) or high-risk myeloproliferative neoplasm will be eligible.\n* Patients with untreated or previously untreated chronic myeloid leukemia (CML) in myeloid blast phase or (Philadelphia chromosome-positive (Ph+) AML are also eligible.\n* Patients with myeloproliferative neoplasms in blast phase will be eligible.\n* Patients with isolated extramedullary myeloid neoplasm will be eligible.\n* Patients with active CNS (central nervous system) disease are eligible.\n* Bilirubin \\\u003C 2mg\u002FdL.\n* AST (aspartate aminotransferase) and\u002For ALT (alanine aminotransferase) \\\u003C 3 x ULN (upper limit of normal) - or \\\u003C 5 x ULN if related to leukemic involvement.\n* Creatinine \\\u003C 1.5 x ULN.\n* Hyperbilirubinemia is allowed if due to Gilbert's hyperbilirubinemia.\n* A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n* Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.\n* Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n* Prior therapy for any of the cohorts may include with hydroxyurea, rescue doses of cytarabine, various combination-chemotherapy regimens, hematopoietic growth factors, azacytidine, decitabine, ATRA (all-trans retinoic acid).\n* Cohort 1: Frontline cohort patients are eligible in the frontline cohort if they are untreated or previously treated already in CR if they received 3 or fewer cycles of previous chemotherapy (including either 1 induction and 2 consolidations or 2 inductions and 1 consolidation).\n* Cohort 2: Salvage cohort in 1st and 2nd salvage patients are eligible in the salvage cohort 2 if they have active disease after first or second relapse or if they are in CR after previously documented first or second relapse as long as they if they have received 3 or fewer cycles of chemotherapy to achieve the most current CR.\n* Cohort 3: Salvage cohort in 3rd salvage and beyond patients may be eligible in salvage cohort 3 if they have active disease after 3rd or greater relapse or if they are in CR after a previously documented relapse (3rd or greater), but may have only received 3 or fewer cycles of chemotherapy to achieve the most current CR.\n* Cohort 4: Maintenance cohort: Patients in CR who are considered by treating physician to benefit from maintenance therapy are eligible for maintenance therapy with dexrazoxane combined with idarubicin plus cytarabine.\n\nExclusion Criteria:\n\n* Any condition, including the presence of laboratory abnormalities, which judged by the investigator, places the patient at unacceptable risk.\n* Active heart disease defined as: Unstable coronary syndromes, unstable or severe angina, recent myocardial infarction (MI) within 6 months.\n* Decompensated heart failure (HF).\n* Clinically significant arrhythmias.\n* Severe valvular disease.\n* History of coronary artery disease (CAD).\n* Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. 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.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements per the judgment of the investigator.\n* Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n* Men and women of childbearing potential who do not practice contraception.","12 Years",{"count":80,"type":20},100,[24],"This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in participants with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect the heart from the side effects of drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin, in participants with blood cancers.",[27,84,85,29,86,87,88],"Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Blasts 10 Percent or More of Bone Marrow Nucleated Cells","Myeloid Sarcoma","Myeloproliferative Neoplasm","Philadelphia Chromosome Positive","2026-05-19",{"date":91,"type":39},"2026-05-22",{"date":93,"type":39},"2018-09-19",{"date":43,"type":20},{"name":45,"class":46},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"100117950","phase-2-fludarabine-phosphate-cytarabine-filgrastim-sndz-gemtuzumab-ozogamicin-and-idarubicin-hydrochloride-in-treating-patients-with-newly-diagnosed-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100117950","NCT00801489","Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia","Inclusion Criteria:\n\n* Patients must have untreated AML, or high-risk myelodysplastic syndromes (MDS) (refractory anemia with excess blasts, \\[RAEB\\], or RAEB \"in transformation\" \\[RAEB-t\\]) characterized by t(8;21), inv(16), or t(16;16); the presence of additional abnormalities is irrelevant\n* Patients must provide written consent\n* Participants will not be excluded based on performance status; for patients with Eastern Cooperative Oncology Group (ECOG) performance status \\>= to 3 the dosing schedule will be discussed with study chairman\n* Patients with organ dysfunction will not be excluded from the study; for patients with evidence of organ dysfunction (creatinine \\>= 1.5, cardiac ejection fraction =\\\u003C 50%, total bilirubin \\>=2 and aspartate aminotransferase \\[AST\\]\u002Falanine aminotransferase \\[ALT\\] \\>= 3 times upper limit of normal \\[ULN\\]), dose adjustments\u002Fomissions will be made\n* Up to one cycle of prior induction therapy will be permitted to include patients in whom presence of \"good-risk\" cytogenetics was initially missed; if the patient is in remission from induction therapy, he\u002Fshe will receive post-remission therapy; if the patient is not in remission then he\u002Fshe will receive induction therapy\n* Patients of child bearing potential should practice effective methods of contraception\n\nExclusion Criteria:\n\n* Pregnant and lactating females will be excluded",{"count":104,"type":20},270,[24],"This phase II trial studies the side effects and how well fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and idarubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a antitumor drug, called calicheamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers calicheamicin to kill them. Colony-stimulating factors, such as filgrastim-sndz, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride may kill more cancer cells.",[108,109,110,111,29,112,113,114,115,116],"Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11","Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11","Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1","de Novo Myelodysplastic Syndrome","Inv(16)","Myelodysplastic Syndrome With Excess Blasts","t(16;16)","t(8;21)","Untreated Adult Acute Myeloid Leukemia","2026-03-24",{"date":119,"type":39},"2026-03-30",{"date":121,"type":39},"2007-04-04",{"date":123,"type":20},"2028-10-11",{"name":45,"class":46},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":161},"100592534","phase-1-a-study-of-cbx-250-in-participants-with-relapsed-or-refractory-myeloid-leukemias-100592534","NCT06994676","A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias","CROSSCHECK-001: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias","CROSSCHECK-001","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Dose Escalation: Male or female participants aged ≥18 years.\n2. Backfill Cohorts: Male or female participants aged ≥12 years for whom no curative treatment options, including transplantation, are available.\n\n   Diagnosis \\& Disease Characteristics\n3. Participants with histological confirmation of advanced hematologic malignancy including:\n\n   1. R\u002FR AML, as defined by standardized criteria (e.g., European LeukemiaNet criteria \\[Dohner 2022\\]; after standard of care therapy. Participants with persistent leukemia after initial therapy or with recurrence of leukemia at any time after achieving a response during or after the course of treatment (including HSCT) are eligible.\n   2. R\u002FR HR-MDS or very high risk MDS as per the Revised International Prognostic Scoring System (IPSS-R; Greenberg 2012) or Molecular International Prognostic Scoring System (IPPS-M, Bernard 2022) who are resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).\n   3. R\u002FR CMML who are resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).\n4. White blood cells must be below 25,000\u002FµL at time of enrollment. Participants may receive cytoreduction prior to enrollment.\n5. Historical documented evidence of HLA-A\\*02:01 allele positivity.\n\n   Performance Level\n6. ECOG PS score 0-1 (if aged ≥18 years); Karnofsky Performance Scale of ≥70 (if aged ≥16 years and \\\u003C18 years); Lansky PS of ≥70 (if aged \\\u003C16 years).\n\n   Prior Therapy\n7. Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 alopecia.\n8. Radiation Therapy: At least 60 days from prior total body irradiation, craniospinal radiation and\u002For ≥50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port).\n9. Stem Cell Infusion: At least 60 days must have elapsed from HSCT and at least 4 weeks (from first dose) must have elapsed from donor lymphocyte infusion without conditioning.\n10. 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.\n11. Anti-Leukemia Therapy: At least 14 days since the completion of anti-leukemic therapy (for example, but not limited to, small molecule or cytotoxic\u002Fmyelosuppressive therapy), with the following exceptions:\n\n    * Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea for cytoreduction can be continued concomitantly with CBX-250, with Study Responsible Physician approval.\n    * Intrathecal chemotherapy at the time of diagnostic lumbar puncture at least 24 hours prior to the start of CBX-250 and may continue prophylactic intrathecal chemotherapy beginning in Cycle 2, at the treating physician's discretion.\n12. 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.\n13. Biologics (e.g. monoclonal antibody therapy): At least 28 days or 5 half-lives, whichever is shorter, have elapsed since the completion of therapy with a biologic agent. Any AE related to prior biologic treatment must be resolved to baseline severity or ≤Grade 1.\n14. Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily) or cytoreductive therapy. Cytoreductive therapy must have approval of the Study Responsible Physician.\n\n    Adequate Organ Function Requirements within 10 Days of Treatment Initiation\n15. Estimated glomerular filtration rate ≥ 45 mL\u002Fmin\u002F1.73 m2 based on local institutional practice for age-appropriate determination (eg, Schwartz formula for pediatric participants or Cockcroft-Gault formula for adults).\n\n    1. Participants ≥18 years: glomerular filtration rate ≥45 mL\u002Fmin\n    2. Participants \\\u003C18 years: ≥45 mL\u002Fmin x (participant's body surface area m2\u002F1.73) • Adequate liver function defined as:\n\n       * Total bilirubin \\\u003C1.5 × the upper limit of normal (ULN) for age or normal conjugated bilirubin, or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in participants with well documented Gilbert's syndrome or hemolysis or who require regular blood transfusions.\n       * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 × ULN (unless attributed to leukemic involvement with discussion with the Study Responsible Physician).\n\n    Sex and Contraceptive\u002FBarrier Requirements\n16. If a female of childbearing potential, willing to use a highly effective method of contraception or double barrier method from the time of enrollment through 120 days following the last study drug dose.\n17. If male of childbearing potential, agrees to use barrier contraception from the time of enrollment through 120 days following the last study drug dose.\n\n    Informed Consent\n18. Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nDiagnosis\n\n1. Previous CTSG targeted therapy or treatment with any pMHC T-cell engager.\n2. Isolated extramedullary relapse.\n3. Active central nervous system (CNS) disease. Participants with prior CNS history can be enrolled if the participant has a negative lumbar puncture following completion of intrathecal chemotherapy).\n\n   Infection\n4. Known HIV infection.\n5. Active hepatitis B infection (participants with documented clearance following treatment are allowed).\n6. Active hepatitis C infection (participants with documented clearance following treatment are allowed).\n\n   Pregnancy and Breastfeeding\n7. Pregnant or nursing women: Negative serum pregnancy tests are required during Screening and a negative serum or urine pregnancy test is required within 72 hours prior to receiving the first study drug administration, in females of childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   Concurrent Conditions\n8. Cardiac Disease:\n\n   * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class \\>II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n   * QTc using Fridericia's correction (QTcF) \\>480 msec\n9. Graft-Versus-Host Disease (GVHD): Active acute or chronic GVHD requiring systemic treatment with immunosuppressive medication. Participants may be on physiological doses of steroids.\n10. Concurrent malignancy in the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy. Concurrent malignancy must be in CR or no evidence of disease (NED) during this timeframe.\n11. History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate.\n\n    Concomitant Medications and Interventions\n12. Any commercially available or investigational anti-leukemic therapy other than CBX-250, with the following exceptions:\n\n    • Intrathecal chemotherapy for CNS prophylaxis is permitted after C1 is complete, at the treating physician's discretion.\n13. Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 14 days or 5-halflives, whichever is shorter, of starting CBX-250. Participants may continue with non-interventional follow-up from previous clinical studies.\n14. Any concurrent systemic treatment to prevent GVHD. Topical treatments for GVHD are permitted.\n15. Known allergy or sensitivity to study drug, including excipients.",{"count":134,"type":20},72,[23],"Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed\u002Frefractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled. CBX-250 will initially be investigated on a fixed step-up dosing schedule. CBX-250 will be administered subcutaneously in 28-day cycles, with the first study drug dose administered on Cycle 1, Day 1. Cycle 1 will consist of a priming phase over 7 days, and a target phase over 28 days. Participants will continue CBX-250 until progressive disease (PD) or unacceptable toxicity. All subsequent treatment cycles will be 28 days.",[60,138,139,140],"Chronic Myelomonocytic Leukemia (CMML)","AML - Acute Myeloid Leukemia","Chronic Myeloid Leukemia",[142,143,144,145,146,147,148,131,149,150],"AML","HR-MDS","CMML","acute leukemia","CBX-250","CBX-250-001","CROSSCHECK","Crossbow","CML","2026-03-12",{"date":153,"type":39},"2026-03-16",{"date":155,"type":39},"2025-07-16",{"date":157,"type":20},"2027-06",{"name":159,"class":160},"Crossbow Therapeutics, Inc.","INDUSTRY",11,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":47},"100302241","phase-1-venetoclax-with-combination-chemotherapy-in-treating-patients-with-newly-diagnosed-or-relapsed-or-refractory-acute-myeloid-leukemia-100302241","NCT03214562","Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia","A Phase 1b\u002F2 Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive AML Induction\u002FConsolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed\u002FRefractory AML","Inclusion Criteria:\n\n* Diagnosis of AML by World Health Organization (WHO) criteria. Patients with high risk myelodysplastic syndrome (MDS) as defined by the presence of \\>= 10% blasts are also eligible at the discretion of the principal investigator\n* Patients older than 65 who are deemed fit to receive intensive chemotherapy by the treating physician will be eligible after discussion with the principal investigator (PI).\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* Creatinine clearance \\>= 30 mL\u002Fmin based on the Cockcroft-Gault equation\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\\u003C 3 x ULN unless considered due to leukemic involvement\n* Ability to understand and provide signed informed consent\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* Only patients who are relapsed, refractory, or intolerant of standard AML therapy will be eligible for Part 1 (minimum of 1 prior line of AML-directed therapy)\n\nExclusion Criteria:\n\n* Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \\[FAB\\] class M3-AML)\n* Patients having received any prior BCL2 inhibitor therapy\n* Subject has known active central nervous system (CNS) involvement with AML\n* Patients with New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 40% by echocardiogram or multi-gated acquisition (MUGA) scan\n* Patients with a history of myocardial infarction within the last 6 months or unstable \u002F uncontrolled angina pectoris or history of severe and\u002For uncontrolled ventricular arrhythmias\n* Patients with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C\n* Patients with known dysphagia, short-gut syndrome, or other conditions that would affect the ingestion or gastrointestinal absorption of drugs administered orally\n* Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study\n* Subject has a white blood cell count \\> 25 x 10{9}\u002FL. (Note: hydroxyurea is permitted to meet this criterion)\n* Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (a) appropriate method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide)",{"count":170,"type":20},116,[23,24],"This phase Ib\u002FII trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, cytarabine, filgrastim and idarubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with combination chemotherapy may work better in treating patients with acute myeloid leukemia.",[29,31,33],"2026-03-03",{"date":176,"type":39},"2026-03-05",{"date":178,"type":39},"2017-09-26",{"date":180,"type":20},"2027-09-30",{"name":45,"class":46},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":189,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":47},"100334179","phase-1-edetate-calcium-disodium-or-succimer-in-treating-patients-with-acute-myeloid-leukemia-or-myelodysplastic-syndrome-undergoing-chemotherapy-100334179","NCT03630991","Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy","Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Therapy","Inclusion Criteria:\n\n* Patients ≥18 years of age, or their legally authorized representative (LAR), must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. For patients \\\u003C18 years of age, a parent or LAR must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. Any required verbal assent and\u002For signed assent of minor must be obtained for participants \\\u003C18 years.\n* Age ≥18 years at the time of signing the informed consent form.\n* Age ≥1 years and \\\u003C18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR)\n* Patients enrolling in the pediatric\u002Fadolescent\u002Fyoung adult exploratory cohort must be:\n\nAge ≥ 1 years and \\\u003C18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR), Or age 18 years -39 years at the time of the signing of the informed consent form\n\n* Diagnosis of any of the following:\n* Newly diagnosed (or untreated) AML with intermediate-risk\u002Fpoor-risk cytogenetics, intermediate-risk\u002Fpoor-risk molecular, or secondary AML (i.e. therapy-related or evolved from antecedent hematologic malignancy)\n* Newly diagnosed (or untreated) myeloid blast phase of myeloproliferative neoplasm (MPN) (including myeloid blast phase of chronic myeloid leukemia \\[CML\\])\n* Newly diagnosed (or untreated) high-risk, very-high risk or secondary MDS\u002Fmyeloid neoplasm\n* Newly diagnosed (or untreated) MDS\u002FMPN (regardless of cytogenetic\u002Fmolecular status)\n* Relapsed and\u002For refractory AML, MDS\u002Fmyeloid neoplasm , MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML)\n* Patients enrolling in the childhood\u002Fadolescent\u002Fyoung adult exploratory cohort may have any of the following diagnoses:\n* High-risk or relapsed\u002Frefractory childhood, adolescent, or young adult malignancies including but not limited to high-risk or relapsed\u002Frefractory ALL or other high-risk or relapsed refractory malignancies\n* This includes, but is not limited to, the following: High-risk ALL\u002FLL including T-ALL\u002FLL, Ph-like ALL\u002FLL, Ph+ B-ALL\u002FLL, B-ALL\u002FLL with CNS lymphoid leukemic involvement, testicular involvement, other extramedullary involvement by ALL\u002FLL; ALL\u002FLL with any of the NCI high-risk features: patients aged 10 years or older and those with a white blood cell count ≥50 × 109 per L), high-risk cytogenetics (MLL rearrangements, near haploidy \\[\\\u003C30 chromosomes\\], low hypodiploidy \\[30-39 chromosomes\\], t\\[17;19\\]\\[q23;p13\\], intrachromosomal amplification of chromosome 21), Burkitts'; Burkitt's-like, Double-Hitt; CNS involvement by any non-primary brain malignancy; Metastatic disease of any malignancy; 5-year survival prognosis of less than 50%, based on the treating physician's assessment\n* Patients on non-investigational regimens or on IND-exempt MD Anderson studies (for hematologic malignancies) of approved drugs are also eligible.\n* Patients on IND studies (for hematologic malignancies) utilizing FDA approved commercially available drugs are eligible.\n* Investigational agents that are not used for treatment of the leukemia per se (e.g. anti-infective prophylaxis or therapy) will be allowed. Other supportive care studies are allowed, even if under an IND.\n* Newly diagnosed MDS or AML, as well as MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML), patients can enroll on this study after start of non-investigational induction therapy, but must be within first 3 cycles of therapy of front-line therapy. Patients with relapsed and\u002For refractory AML, MDS, MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML) can enroll. Newly diagnosed patients enrolling in the exploratory cohort with high-risk malignancies can enroll after the start of non-investigational therapy but must be within first 3 cycles of front-line therapy.\n* Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid-Blast Phase of MPN and Chronic Myeloid Leukemia (CML) are allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 3 or Lansky or Karnofsky ≥ 30 at study entry; patients who are unable to walk, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy):\n* Serum creatinine =\\\u003C 1.5 mg\u002FdL\n* Total Bilirubin =\\\u003C 2.0 x upper limit of normal (ULN), unless the patient has Gilbert's\n* AST (SGOT) and\u002For ALT (SGPT) =\\\u003C 2.0 x ULN\n* Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partner's vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential\n* Extramedullary disease is allowed as long as it can be measured and followed for response.\n\nNote: Patients can be considered MDS by either WHO or FAB150 criteria Note: MDS risk status assessment is based on IPSS-R and\u002For IPSS-M. AML risk status assessment is based on ELN and World Health Organization classification\n\nExclusion Criteria:\n\n* Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk\n* Acute Promyelocytic leukemia (APL)","1 Year",{"count":191,"type":20},58,[23],"This phase I trial studies the side effects and best dose of edetate calcium disodium or succimer in treating patients with acute myeloid leukemia or myelodysplastic syndrome undergoing chemotherapy. Edetate calcium disodium or succimer may help to lower the level of metals found in the bone marrow and blood and may help to control the disease and\u002For improve response to chemotherapy.",[27,195,84,196,29,197,198,87,31,199,200,201,33,202,203,204,205,206],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Myelodysplastic Syndrome","Myelodysplastic\u002FMyeloproliferative Neoplasm","Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Recurrent Myelodysplastic Syndrome","Recurrent Myelodysplastic\u002FMyeloproliferative Neoplasm","Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Refractory Myelodysplastic Syndrome","Secondary Acute Myeloid Leukemia","Secondary Myelodysplastic Syndrome","Very High Risk Myelodysplastic Syndrome","2026-02-26",{"date":209,"type":39},"2026-03-02",{"date":211,"type":39},"2018-10-11",{"date":213,"type":20},"2027-04-30",{"name":45,"class":46},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100591948","phase-2-rvu120-rollover-study-100591948","NCT06987058","RVU120 Rollover Study","An Open-label Multicenter Rollover Study to Provide Continued Treatment to Participants Previously Enrolled in a RVU120 Clinical Study","ROVER-01","Inclusion Criteria:\n\n1. The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles.\n2. The participant is currently benefiting from, and expected to continue to benefit from, RVU120-based treatment according to the criteria set out in the parent study protocol and according to the judgment of the investigator and sponsor.\n3. The participant does not have access to commercially available comparator anticancer therapy.\n4. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n5. The participant signed the rollover study ICF prior to any study-related procedure or study data collection.\n6. The participant agrees not to donate blood during study participation and until 28 weeks (\\~6.5 months) after the last dose.\n7. The investigator considers the participant to be eligible for participation in the rollover study.\n\nExclusion Criteria:\n\n1. Presence of toxicity that cannot be adequately managed.\n2. Concurrent participation in any therapeutic clinical study other than the parent study.",{"count":5,"type":20},[24],"This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when continued under the same regimen as in the parent study.\n\nTo be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. Once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.",[227,228,60],"Advanced Solid Tumors","Acute Myeloid Leukaemia (AML)",[230,231,232,233,234,142,235],"Relapse","Refractory","Metastatic","Advanced","Solid Tumor","Myelodysplastic syndrome","2025-09-23",{"date":238,"type":39},"2025-09-24",{"date":240,"type":20},"2025-12-15",{"date":242,"type":20},"2026-08",{"name":244,"class":160},"Ryvu Therapeutics SA",2,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":21,"phases":255,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100518725","phase-1-study-of-vip943-in-subjects-with-advanced-cd123-hematologic-malignancies-100518725","NCT06034275","Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies","An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP943 Monotherapy in Subjects With Advanced CD123+ Hematologic Malignancies","Inclusion Criteria:\n\n* Histologically confirmed AML, B-ALL or MDS. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.\n* Evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow or blood myeloblasts (MDS) to allow for assessment of drug activity.\n* Evidence of CD123 expression from a local laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n\nExclusion Criteria:\n\n* Known central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Clinically significant cardiac disease including congestive heart failure \\> New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.",{"count":254,"type":20},36,[23],"Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies",[27,258,60],"B-cell Acute Lymphoblastic Leukemia",[260,261,262,263,264,142,265,266,267,268],"ADC","Hematologic Malignancies","Leukemia","CD123","B-ALL","MDS","Relapsed\u002F Refractory","Hematologic Diseases","Bone Marrow Diseases","2024-11-13",{"date":271,"type":39},"2024-11-15",{"date":273,"type":39},"2023-09-13",{"date":275,"type":20},"2025-12-31",{"name":277,"class":160},"Vincerx Pharma, Inc.",5,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100464378","the-patient-cohort-of-the-national-center-for-precision-medicine-in-leukemia-100464378","NCT05326919","The Patient Cohort of the National Center for Precision Medicine in Leukemia","eTHEMA","Inclusion Criteria:\n\n* Patient with newly diagnosed previously untreated de novo, secondary or therapy-related leukemia or related disorders (LRD), including AML, ALL, HR-MDS (according to the international score IPSS), and MNP-related myelofibrosis\n* Patient informed and not opposed to participating\n* Affiliation to social security or any health insurance\n\nExclusion Criteria:\n\n* LRD which is not morphologically proven (patients with granulocytic sarcoma may be included)\n* Previous treatment for LRD, apart from:\n\n  * Hydroxyurea or previous MDS\u002FMPN-CML therapy in AML patients\n  * Steroids, vincristine, intrathecal prophylactic or curative injection or previous CML therapy in ALL patients\n  * Erythroid stimulating agents (ESAs), luspatercept, granulocyte colony-stimulating factor (G-CSF), eltrombopag or other TPO agonist, iron chelation therapy, hypomethylating agents (HMAs), lenalidomide or any investigational drug previously used to treat MDS in HR-MDS patients\n  * Hydroxyurea, standard or pegylated interferon alpha, ruxolitinib or other JAK inhibitors, busulfan, anagrelide, ESAs or any investigational drug previously used to treat MPN in MPN-related myelofibrosis patients\n* Patient under guardianship \u002F curatorship\n* Patient under AME\n* Opposition of the patient to be enrolled in the eTHEMA cohort",{"count":287,"type":20},3000,"OBSERVATIONAL","If for years the treatment strategy of leukemia and related disorders (LRDs, including acute leukemias and predisposition syndromes) has been based solely on whether the patient could receive or not intensive chemotherapy and transplantation, the advent of new targeted or less targeted drugs has led to the development of a growing number of new therapeutic approaches, very often offered to specific patient\u002Fdisease subsets, justifying the generic term of 'precision medicine'.\n\nAs an international leukemia center of excellence, THEMA, the French National Center for Precision Medicine in Leukemia (selected as IHUB-2 by the French National Agency for Research), is a care, research, transfer and education initiative located at the Saint-Louis Research Institute (IRSL) in Paris and devoted to precision medicine in leukemia in a real-life environment.\n\nThe present non-interventional study (eTHEMA) is a pillar of the whole THEMA project. As a prerequisite for precision medicine, this program focuses on individual data collection, aiming to collect high-quality data not only in patients treated into prospective clinical trials, but in every THEMA patient with a special interest in outpatients' care and research.\n\nThe primary objective of this non-interventional study is to describe the baseline characteristics planned treatments and outcomes of patients newly diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or myeloproliferative neoplasm (MPN)-related myelofibrosis, when managed and treated according to standard diagnosis and care practices.",[27,291,60,292,293],"Acute Lymphoblastic Leukemia","Secondary Myelofibrosis in Myeloproliferative Disease","Myeloproliferative Neoplasm, Unclassifiable","2024-05-26",{"date":296,"type":39},"2024-05-29",{"date":298,"type":39},"2022-03-28",{"date":300,"type":20},"2042-03",{"name":302,"class":46},"Assistance Publique - Hôpitaux de Paris",3]