[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelodysplastic-syndrome-with-excess-blasts-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelodysplastic-syndrome-with-excess-blasts-2":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100351035","phase-1-clinical-trial-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-tuspetinib-hm43239-in-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-100351035",false,"NCT03850574","Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia","A Phase 1\u002F2 Open Label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)","TUSCANY","Inclusion Criteria for Parts A\u002FB\u002FC:\n\n* Study participant is defined as having morphologically documented primary or secondary AML, MDS-IB2 (≥ 10% bone marrow blasts), or CMML by the World Health Organization (WHO) criteria (2016), and fulfills one of the following:\n\n  1. Refractory to at least 1 cycle of prior therapy\n  2. Relapsed after achieving remission with a prior therapy\n* Study participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Study participant's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), at 4 weeks for biologic or cellular immunotherapies, or least 5 half-lives for prior experimental agents or noncytotoxic agents, including immunosuppressive therapy post hematopoietic stem cell transplantation (HSCT). Upon discussion with the Medical Monitor, a shorter than stated washout period may be considered provided that the study participant has recovered from any clinically relevant safety issue and recovered to Grade ≤ 1 toxicity from prior therapies.\n* Study participant must meet the following criteria as indicated on the clinical laboratory tests.\n\n  1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× institutional upper limit normal (ULN)\n  2. Total serum bilirubin ≤ 1.5× institutional ULN\n  3. Creatinine clearance as calculated by the Cockcroft-Gault formula or measured by 24-h urine collection of \\> 45 mL\u002Fmin.\n* Study participant is suitable for oral administration of study drug and has minimum life expectancy (≥ 3 months)\n* Female study participants must be either:\n* Of non-childbearing potential\n\n  1. Post-menopausal (defined as at least 1 year without any menses) prior to screening, or\n  2. Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening)\n* Or, if of childbearing potential,\n\n  1. Must have a negative serum or urine pregnancy test at screening (within 72 hours prior to start of treatment), and\n  2. Must use an acceptable highly effective method of birth control starting at screening and throughout the study period and for 90 days after the final study drug administration.\n* Female study participants must not be breastfeeding at screening and during the study period, and for 90 days after the final study drug administration\n* Female study participants must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.\n* Male study participants and their female spouse\u002Fpartners who are of childbearing potential must be using highly effective contraception starting at screening and continue throughout the study period and for 90 days after the final study drug administration.\n* Male study participants must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.\n* Study participant agrees not to participate in another interventional study while on treatment.\n\nExclusion Criteria for Parts A\u002FB\u002FC:\n\nStudy participants must not enter the study if any of the following exclusion criteria are met:\n\n* Study participant was diagnosed with acute promyelocytic leukemia (APL).\n* Study participant has known BCR-ABL-positive leukemia.\n* Study participant has an active malignancy other than AML, MDS-IB2, or CMML.\n* Study participant has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from prior AML, MDS-IB2, or CMML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery)\n* Study participant has had hematopoietic stem cell transplant (HSCT) and meets any of the following criteria:\n\n  1. Has undergone HSCT within the 2-month period prior to the first study dose\n  2. Has clinically significant graft-versus-host-disease (GVHD) requiring treatment\n  3. Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant\n  4. Had a donor lymphocyte infusion (DLI) ≤ 30 days prior to the first study dose.\n* Study participant has meningeal or central nervous system (CNS) involvement with leukemia or other CNS disease related to underlying and secondary effects of malignancy.\n* Study participant has disseminated intravascular coagulation abnormality (DIC).\n* Study participant has had major surgery within 4 weeks prior to the first study dose.\n* Study participant has had radiation therapy within 4 weeks prior to the first study dose.\n* Study participant has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or study participant with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.\n* Study participant has any of the following cardiac abnormalities of history:\n\n  1. Study participant has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval \\> 250 milliseconds (ms).\n  2. Study participant has a mean QT interval (QTc) by Friderica's method (QTcF) \\> 450 ms in three successive screening measurements.\n  3. Study participant has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT, syndrome, family history of long QT syndrome.\n* Study participant is known to have active infection including any identified active COVID-19 infection.\n* Study participant is known to have human immunodeficiency virus infection.\n* Study participant has known active hepatitis B or C, or other active hepatic disorder.\n* Study participant has any condition which, in the Investigator's opinion, makes the study participant unsuitable for study participation.\n* Study participant has a history of Grade 3 or 4 non-hematologic toxicity related to tyrosine kinase inhibitor.\n\nInclusion Criteria for Part D:\n\n* Study participant is defined as having morphologically documented newly diagnosed previously untreated primary or secondary AML by the World Health Organization (WHO) criteria (2016) and considered ineligible to receive intensive chemotherapy.\n\nStudy participants ≥ 75 years of age are considered ineligible to receive intensive chemotherapy if they meet any of the following criteria:\n\n1. ECOG Performance Status of 2 or 3;\n2. Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina;\n3. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%;\n4. Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 45 ml\u002Fmin;\n5. Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0×ULN;\n6. Any other comorbidity that the Investigator judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Medical Monitor during screening and prior to treatment.\n\nStudy participants are considered ineligible to receive intensive chemotherapy based on their age being ≥ 75 years.\n\n* Study participant \\\u003C 75 years has an ECOG performance status ≤ 2; study participant ≥ 75 years has an ECOG performance status 0-2.\n* Study participant must meet the following criteria as indicated on the clinical laboratory tests:\n\n  1. Serum AST and ALT ≤ 3× institutional ULN unless considered due to leukemic organ involvement.\n  2. Total serum bilirubin ≤ 3x institutional ULN unless considered due to leukemic organ involvement for study participants \\\u003C 75 years; total serum bilirubin ≤ 1.5x institutional ULN (or ≤ 3x institutional ULN if documented history of Gilbert's syndrome) unless considered due to leukemic organ involvement for study participants ≥ 75 years.\n  3. Creatinine clearance as calculated by the Cockcroft-Gault formula or measured by 24-h urine collection of ≥ 30 mL\u002Fmin for study participants \\\u003C 75 years; creatinine clearance as calculated by the Cockcroft-Gault formula or measured by 24-h urine collection of ≥ 45 mL\u002Fmin for study participants ≥ 75 years.\n* Study participant is suitable for oral administration of study drug and has minimum life expectancy (≥ 3 months)\n* Female study participants must be either:\n* Of non-childbearing potential\n\n  1. Post-menopausal (defined as at least 1 year without any menses) prior to screening, or\n  2. Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening)\n* Or, if of childbearing potential,\n\n  1. Must have a negative serum or urine pregnancy test at screening (within 72 hours prior to start of treatment), and\n  2. Must use an acceptable highly effective contraception starting at screening and throughout the study period and for 90 days after the final study drug administration.\n* Female study participants must not be breastfeeding at screening and during the study period, and for 90 days after the final study drug administration.\n* Female study participants must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.\n* Male study participants and their female spouse\u002Fpartners who are of childbearing potential must be using highly effective contraception starting at screening and continue throughout the study period and for 90 days after the final study drug administration.\n* Male study participants must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.\n* Study participant agrees not to participate in another interventional study while on treatment.\n\nExclusion Criteria for Part D:\n\nStudy participants must not enter the study if any of the following exclusion criteria are met:\n\n* Study participant was diagnosed with acute promyelocytic leukemia (APL).\n* Study participant has known BCR-ABL-positive leukemia.\n* Study participant has an active malignancy other than AML.\n* Study participant has received treatment with the following:\n\n  1. An HMA, VEN (or other BCL-2 inhibitor), a tyrosine kinase inhibitor (TKI), a FLT3 inhibitor (FLT3i), a hematopoietic stem cell transplant (HSCT), and\u002For a chemotherapeutic agent for antecedent myeloid neoplasm (Note: Prior chemotherapy for solid tumors considered in remission is allowed.)\n  2. CAR-T cell therapy\n  3. Experimental therapies for antecedent myeloid neoplasms\n  4. Current participation in another research or observational study\n* Study participant has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from treatment for antecedent myeloid neoplasms (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, immunosuppressive therapy, radiation, or surgery).\n* Study participant has meningeal or central nervous system (CNS) involvement with leukemia or other CNS disease related to underlying and secondary effects of malignancy.\n* Study participant has disseminated intravascular coagulation abnormality (DIC).\n* Study participant has had major surgery within 4 weeks prior to the first study dose.\n* Study participant has had radiation therapy within 4 weeks prior to the first study dose.\n* Study participant has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or study participant with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.\n* Study participant has any of the following cardiac abnormalities of history:\n\n  1. Study participant has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval \\> 250 milliseconds (ms).\n  2. Study participant has a mean QT interval (QTc) by Friderica's method (QTcF) \\> 450 ms in three successive screening measurements.\n  3. Study participant has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT, syndrome, family history of long QT syndrome.\n* Study participant is known to have active infection, including any identified active COVID-19 infection.\n* Study participant is known to have human immunodeficiency virus infection.\n* Study participant has known active hepatitis B or C, or other active hepatic disorder.\n* Study participant has any condition which, in the Investigator's opinion, makes the study participant unsuitable for study participation, including a chronic respiratory disease that requires continuous oxygen, or a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, or cardiovascular disease, or any other medical condition or known hypersensitivity to any of the study medications including excipients of VEN and AZA that in the opinion of the Investigator would adversely affect participating in this study.\n* Study participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal) or other medical conditions (e.g., infection, heart failure, COPD flare, etc.).\n* Study participant has a white blood cell count \\> 25 × 10\\^9\u002FL. (Treatment with hydroxyurea or use of leukapheresis are permitted to meet this criterion.)","ALL","18 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The main purpose of this study is to identify a safe and potentially effective dose of tuspetinib to be used in future studies in study participants diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) that is relapsed or refractory after at least one line of prior therapy, or in study participants with newly diagnosed AML. Tuspetinib will be administered as a single agent or in combination with other drugs (venetoclax or venetoclax plus azacitidine), as specified for each part of the study.",[28,29,30,31,32],"Leukemia, Myeloid, Acute","Refractory AML","Relapsed Adult AML","Myelodysplastic Syndrome With Excess Blasts-2","Chronic Myelomonocytic Leukemia",[34,35,36,37,38,39,40,32,41,42,43,44],"Tuspetinib","Acute Myeloid Leukemia","AML","Relapsed","Refractory","Myelodysplastic Syndromes with Increased Blasts Grade 2","MDS-IB2","CMML","Venetoclax","Azacitidine","Newly Diagnosed","RECRUITING","2025-08-20",{"date":48,"type":49},"2025-08-26","ACTUAL",{"date":51,"type":49},"2019-03-11",{"date":53,"type":21},"2027-04",{"name":55,"class":56},"Aptose Biosciences Inc.","INDUSTRY",34,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100493314","phase-1-bxcl701-phase-1-rr-acute-myeloid-leukemia-or-myelodysplastic-syndrome-100493314","NCT05703542","BXCL701 Phase 1 R\u002FR Acute Myeloid Leukemia or Myelodysplastic Syndrome","A Phase 1 Study of BXCL701 in Relapsed\u002FRefractory Acute Myeloid Leukemia or Relapsed\u002FRefractory Myelodysplastic Syndrome With Excess Blasts - 2","Inclusion Criteria:\n\n* Age 18 and older\n* Subjects with evidence of AML that meet at least one of the following criteria:\n\n  * Relapsed AML: as evidence by ≥5% myeloblasts in the bone marrow, or reappearance of blasts in the peripheral blood\n  * Refractory AML: ≤2 prior induction regimens (example: patients who receive 7 + 3 followed by 5 + 2 would count as one induction regimen) OR\n  * Subjects with WHO defined myelodysplastic syndrome with excess blasts-2 (MDS-EB-2) as defined by blast count between 10% - 19% in the bone marrow or peripheral blood blasts 5% - 19% or Auer rods noted and who are refractory or relapsed after at least 4 cycles of a hypomethylating agent (azacitidine, decitabine, or oral decitabine\u002Fcedazuridine)\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix B).\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Estimated Creatinine Clearance ≥30 mL\u002Fmin by Cockcroft-Gault calculation\n  * Total Bilirubin ≤1.5 x ULN\\*\n  * ALT and AST ≤3x ULN\\*\n  * EF \\>35%: \\*unless considered due to leukemic organ involvement. NOTE: Subjects with Gilbert's Syndrome may have a total bilirubin \\>1.5 x ULN per discussion with overall study PI.\n* WBC \\\u003C25,000 \u002F µL on day of 1 of cycle 1; cytoreduction is permitted with hydroxyurea which is allowed throughout cycle 1 until cycle 2 day 1\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with treated central nervous system (CNS) disease are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression\n* Male subjects must agree to refrain from unprotected sex and sperm donation from initial drug administration until 90 days after the last dose of study drug.\n* Females of childbearing potential (i.e not postmenopausal for at least 1 year or not surgically sterile) must have negative results by a serum pregnancy test performed within 7 days of day 1. Females must agree to refrain from unprotected sex\u002Fadequate contraception via barrier method from initial drug administration until 90 days after the last dose of study drug.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Subjects who have known Acute Promyelocytic Leukemia.\n* Subjects with active CNS involvement with AML.\n* Participants who have had chemotherapy, other investigational therapy, immunotherapy, or radiotherapy within 2 weeks or 5 half-lives from prior therapy, whichever is longer, prior to the first dose of study medication. Hydroxyurea is allowed with no required washout, and hydroxyurea may be administered for the first cycle of the protocol for patients who have proliferative disease (WBC \\\u003C25K) with a maximum allowed dose of 6 g per day.\n* Participants who have received oral tyrosine kinase inhibitors (TKIs) within two weeks or 5 half-lives (whichever is longer) of the first dose of study medication\n* Subjects who are \\\u003C100 days from allogeneic bone marrow transplant.\n* Subjects who have active graft-versus host disease are not eligible. Patients should be off calcineurin inhibitors for at least 28 days (4 weeks) prior to start of study treatment C1D1\n* Participants 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.\n* Participants who are receiving any other investigational agents.\n* Concomitant medications: It is strongly encouraged that patients who are on strong inducers or inhibitors of CYP3A4 be changed to a comparable drug if possible. If not possible, then dose reductions will need to be made as per APPENDIX C. Patients are not permitted to be on a gliptin (sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin).\n* Patients with a history of orthostatic hypotension with a baseline SBP \\\u003C100, or history of uncontrolled hypertension.\n* Subject has cardiovascular disability status of NYHA class ≥2\n* No concurrent active malignancies are allowed on study for ≥2 years prior to treatment start with the exception of currently treated basal cell or squamous cell carcinoma of the skin, carcinoma in-situ of the cervix or breast, or low-grade prostate cancer.\n* Patients with known active hepatitis B virus (HBV) infection should be excluded because of potential effects on immune function and\u002For drug interactions. However, if a patient has HBV history with an undetectable HBV load by polymerase chain reaction (PCR), no liver-related complications, and is on definitive HBV therapy, then he\u002Fshe would be eligible for study.\n* Patients with known active hepatitis C virus (HCV) infection. Patients with a history of HCV infection who received definitive therapy and has an undetectable viral load by PCR would be eligible.\n* Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Any other prior or ongoing condition, in the opinion of the investigator, that could adversely affect the safety of the patient or impair the assessment of study results. As patients with AML and MDS are prone to infections, if patients are actively being treated with appropriate antibiotics or antifungal therapy with clinical evidence of infection control, then they will be considered eligible for study.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because BXCL701 has 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 these agents, breastfeeding should be discontinued.\n* Inclusion of Women and Minorities: Both men and women of all races and ethnic groups are eligible for this trial.",{"count":66,"type":21},24,[24],"The goal of this research study is to find the safest and most effective dose of the study drug, BXCL701, for the treatment of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).\n\nThe names of the study drugs involved in this study are\u002Fis:\n\n* BXCL701",[35,31],[35,71,72,73],"Myelodysplastic Syndrome with Excess Blasts-2","Refractory Acute Myeloid Leukemia","Relapsed Acute Myeloid Leukemia","2025-07-17",{"date":76,"type":49},"2025-07-18",{"date":78,"type":49},"2023-02-02",{"date":80,"type":21},"2026-07-31",{"name":82,"class":83},"Eric Stephen Winer, MD","OTHER",1]