[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aml-with-mutated-npm1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aml-with-mutated-npm1":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,78],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100636507","phase-1-dose-finding-study-to-evaluate-the-safety-of-bsb-2002-in-relapsed-or-refractory-acute-myeloid-leukemia-aml-patients-with-npm1-mutation-100636507",false,"NCT07566585","Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation","A Phase 1 Multicenter Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation","Inclusion Criteria:\n\n1. Male or female patients, ages 18 years or older,\n2. AML diagnosed per ELN criteria1 which has been treated with at least two lines of therapy,\n\n   1. which is relapsed (after previously complete remission, CR, CRh or CRi), or\n   2. refractory (failed to achieve complete remission) to the last treatment\\*, \\*Primary refractory patients should have received at least two cycles of induction treatment\n3. Patients who are MRD positive by NGS for NPM1 after being MRD negative following the last treatment\n4. HLA-A\\*02:01,\n5. Positive for NPM1 mutation type A, D, G or H (see Appendix 3)2\n6. Adequate venous access for apheresis or agree to use of a central line for apheresis collection,\n7. Willing and able to provide informed consent and adhere to all study requirements.\n\nExclusion Criteria:\n\n1. Leukemic blast count of \\>20,000\u002Fμl. If the blast count can be maintained below the threshold with hydroxyurea, the patient would be eligible.\n2. Patients with extramedullary only AML.\n3. Patients that are candidates for hematopoietic stem cell transplant.\n4. Patients that are eligible to receive an approved targeted therapy.\n5. Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-2002 (day 1).\n6. Subject has had hematopoietic stem cell transplant (HSCT) and has any of the following:\n\n   1. Is within 3 months of transplant;\n   2. Has clinically significant graft-versus-host disease requiring systemic treatment;\n   3. Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant.\n7. Other malignancy that requires treatment.\n8. Uncontrolled bacterial, viral, or fungal infections at time of enrollment.\n9. Active Hepatitis B or C infection.\n10. Seropositive for Human Immunodeficiency Virus-1 or -2.\n11. CNS involvement refractory to intrathecal chemotherapy and\u002For standard cranial- spinal radiation.\n12. Subject has congestive heart failure NYHA class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless an echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.\n13. Renal insufficiency, with estimated creatinine clearance of \\\u003C 40 ml\u002Fmin\u002F1.73m2 by the Cockcroft-Gault equation with adjustment if the weight is ≥ 125% of ideal body weight OR inadequate renal function defined by serum creatinine \\> 1.6 mg\u002FdL\n14. Total bilirubin \\> 2x upper limit of normal (unless attributed to Gilbert's Syndrome).\n15. AST or ALT \\> 3x upper limit of normal.\n16. Pregnant or lactating women.\n17. Eastern Cooperative Oncology Group (ECOG) performance status \\>2.\n18. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids at any dose)\n19. Women of childbearing potential (WOCBP) and men who are fertile and are unwilling to use an effective birth control method or abstinence for 12 months. Effective forms of birth control are listed in the Contraception section.\n20. Any condition, in the judgement of the Investigator, that would interfere with study participation, pose a significant risk to the patient, or interfere with study data interpretation.","ALL","18 Years",{"count":19,"type":20},19,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to test BSB-2002 which is a new type of cellular therapy to treat blood cancer (AML). It will evaluate the safety of BSB-2002 and also determine whether it works to prevent relapse of your cancer.",[26,27,28],"AML - Acute Myeloid Leukemia","AML With Mutated NPM1","AML, Adult Recurrent",[30,31],"TCR","T-cell therapy","RECRUITING","2026-04-27",{"date":35,"type":36},"2026-05-05","ACTUAL",{"date":38,"type":36},"2026-04-21",{"date":40,"type":20},"2027-09",{"name":42,"class":43},"BlueSphere Bio, Inc","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100516228","phase-1-safety-and-tolerability-of-ziftomenib-combinations-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100516228","NCT06001788","Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed\u002FRefractory Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Has been diagnosed with relapsed\u002Frefractory AML.\n* Has a documented NPM1 mutation or KMT2A rearrangement.\n* Has a documented FLT3 mutation (cA-3 only).\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.\n* Has adequate hepatic and renal function as defined per protocol.\n* Has an ejection fraction above a protocol defined limit.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.\n* Has agreed to use contraception as defined per protocol.\n\nKey Exclusion Criteria:\n\n* Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.\n* Has clinically active central nervous system leukemia.\n* Has an active and uncontrolled infection.\n* Has a mean corrected QT interval (QTcF) \\> 480ms.\n* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \\\u003C14 days or within 5 drug half-lives prior to the first dose of study intervention.\n* Has had major surgery within 4 weeks prior to the first dose of study intervention.\n* Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.\n* Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD\n* Participant is pregnant or lactating.",{"count":53,"type":20},171,[23],"The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed\u002Frefractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.",[57,27,58,59,60,61,62,63,64,65,66,67],"AML","Hematologic Malignancy","KMT2Ar","NPM1 Mutation","MLL Rearrangement","Leukemia","Acute Myeloid Leukemia","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Acute Leukemia","Neoplasms by Histologic Type","2026-04-10",{"date":70,"type":36},"2026-04-14",{"date":72,"type":36},"2024-02-22",{"date":74,"type":20},"2027-08",{"name":76,"class":43},"Kura Oncology, Inc.",45,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100495744","phase-1-a-study-to-investigate-the-safety-and-tolerability-of-ziftomenib-in-combination-with-venetoclaxazacitidine-venetoclax-73-or-73quizartinib-in-patients-with-aml-100495744","NCT05735184","A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax\u002FAzacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML","Phase 1 Study of Venetoclax\u002FAzacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine\u002FDaunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed\u002Frefractory AML\n\n  * Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Adequate liver, renal, and cardiac function according to protocol defined criteria\n* A female of childbearing potential must agree to use adequate contraception as well as a double barrier method from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or use a double barrier method of contraception from the time of screening through 180 days following the last dose of study intervention\n\n  * Female patients of childbearing potential who receive quizartinib in Arm C should use a highly effective method of contraception during quizartinib treatment and for 7 months after the last dose\n\nKey Exclusion Criteria:\n\n* Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia\n* Known history of BCR-ABL alteration\n* Advanced malignant hepatic tumor\n* Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery\n* Active central nervous system (CNS) involvement by AML.\n* Clinical signs\u002Fsymptoms of leukostasis or WBC \\> 25,000 \u002F microliter. Hydroxyurea and\u002For leukapheresis and\u002For up to 2 doses of cytarabine if used per institutional SOC for control of leukocytosis are permitted to meet this criterion\n* Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia\n* Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection\n* For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and\u002For leukapheresis and\u002For up to 2 doses of cytarabine per institutional standards to control leukocytosis, or prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia\n* For relapsed\u002Frefractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational \\\u003C 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug\n* Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol\n* Mean QT interval corrected for heart rate by Fredericia's formula (QTcF)\n\n  * Arm A and Arm B: \\>480 ms on triplicate ECGs\n  * Arm C: \\>450 ms on triplicate ECGs\n* Uncontrolled infection\n* Women who are pregnant or lactating\n* An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled\u002Fprogressing\n* Patients who have active GVHD requiring \\>0.5 mg\u002Fkg prednisone or any new or increase in immunosuppressants in the prior 2 weeks for GVHD treatment",{"count":86,"type":20},420,[23],"Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.\n\nThis protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.\n\nThe purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.",[63,90,91,27,92,93,60,59,94,95],"Mixed Lineage Leukemia Gene Mutation","Refractory AML","Acute Myeloid Leukemia Recurrent","Acute Myeloid Leukemia, in Relapse","Myeloid Sarcoma","Nucleophosmin 1-mutated Acute Myeloid Leukemia",[62,97,57,98,99,100,101,66,102,103,104,105,106,107,108,91,93,109],"Myeloid","Hematological malignancy","KMT2A","NPM1","Menin","Newly diagnosed AML","Untreated AML","venetoclax","cytarabine","daunorubicin","KMT2A-r","NPM1 mutation","quizartinib","2026-03-11",{"date":112,"type":36},"2026-03-13",{"date":114,"type":36},"2023-07-18",{"date":116,"type":20},"2030-04",{"name":76,"class":43},44]