[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-recurrent":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100366362","phase-2-clag-go-for-patients-with-persistent-relapsed-or-refractory-aml-100366362",false,"NCT04050280","CLAG-GO for Patients With Persistent, Relapsed or Refractory AML","A Phase II Study of Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor With Fractionated Gemtuzumab Ozogamicin (CLAG-GO) for the Treatment of Patients With Persistent, Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Adult patients age 18 years or older, with a pathologically confirmed diagnosis of AML \\[excluding acute promyelocytic leukemia (APL)\\] according to WHO criteria. AML may be de novo, or following a prior hematologic disease and\u002For therapy-related.\n2. Patients must have relapsed after or be refractory to at least one course of an intensive chemotherapy regimen, for example anthracycline\u002Fcytarabine (\"7+3\" or daunorubicin and cytarabine liposome). Patients with residual disease on day 13-22 of initial induction chemotherapy are eligible, provided the bone marrow cellularity is ≥ 30% AND bone marrow blasts are ≥ 20%. Hypomethylating agents such as azacitidine or decitabine are allowed as a prior therapy, but are not considered an intensive chemotherapy regimen.\n3. Eastern Cooperative Oncology Group performance status of 0-2.\n4. Any systemic chemotherapy and any radiotherapy must be completed at least 7 days prior to initiation of protocol therapy, with the exception of hydroxyurea or 6-mercaptopurine for cytoreduction.\n5. At least 20% expression of CD33 as determined by flow cytometry or immunohistochemical staining.\n6. Adequate renal function, defined as a serum creatinine less than 1.8 mg\u002FdL.\n7. Adequate hepatic function, defined as a direct bilirubin less than 2 times the institutional upper limit of normal (ULN) and AST, ALT and Alkaline Phosphatase less than 3 times the ULN.\n8. Patients who relapse after allogeneic hematopoietic stem cell transplantation are eligible, provided they are at least 60 days from stem cell infusion, do not have \\> grade 1 graft versus host disease, and have been off all immunosuppressive therapy for at least 2 weeks.\n9. Female patients of childbearing potential must have a negative pregnancy test and agree to use an adequate method of contraception as defined by the protocol. This must persist through the treatment period until at least 6 months after the last dose of chemotherapy or GO.\n10. Male subjects who are able to father children and are having intercourse with females of childbearing potential must also agree to an acceptable method of contraception through the treatment period until at least 3 months after the last dose of chemotherapy or GO, and must refrain from sperm donation during this period.\n11. Ability to give written informed consent.\n\nExclusion Criteria:\n\n1. Patients with acute promyelocytic leukemia (FAB-M3) or chronic myelogenous leukemia in blast phase.\n2. Isolated myeloid sarcoma. Patients must have marrow involvement with AML to enter the study.\n3. Patients with known active AML involvement of the central nervous system.\n4. Prior treatment with gemtuzumab ozogamicin or cladribine for AML. Prior treatment with cytarabine is permitted.\n5. As patients will be receiving G-CSF prior to chemotherapy, patients presenting with symptomatic leukostasis (as judged by the investigator) are excluded. Hydroxyurea, 6-mercaptopurine and\u002For leukapheresis for blast count control (see inclusion criterion #4) for patients with asymptomatic hyperleukocytosis is permitted before starting treatment, but must be stopped for at least 24 hours prior to starting protocol treatment.\n6. Active uncontrolled infection. Patients on prophylactic antibacterial, antifungal, and\u002For antiviral agents and patients whose infections are controlled with these agents are eligible.\n7. Known active hepatitis B or C or other known active hepatic disorder.\n8. Any history of veno-occlusive disease (VOD)\u002Fsinusoidal obstruction syndrome (SOS).\n9. Active concurrent malignancy, unless disease-free for at least 3 years. Subjects with treated non-melanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been treated surgically or with definitive radiotherapy.\n10. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that per investigator's judgment would limit compliance with study requirements.","ALL","18 Years",{"count":19,"type":20},39,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study involves evaluating a combination of chemotherapy drugs known as \"CLAG-GO\" \\[cladribine, cytarabine, granulocyte-colony stimulating factor (G-CSF) and gemtuzumab ozogamicin (GO)\\] in the treatment of acute myeloid leukemia (AML) that has not responded well to standard therapy or has returned after an initial remission (relapsed). The trial will be conducted at the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC). Potential participants will go through a screening period to see if they are eligible to join the study. If eligible, participants will be hospitalized for 4-5 weeks to receive study treatment with CLAG-GO, called induction chemotherapy. If tests show that the cancer is in remission after induction chemotherapy, participants may undergo further chemotherapy (known as consolidation) or may proceed with bone marrow\u002Fstem cell transplantation. Patients who receive consolidation chemotherapy and remain in remission may have up to 8 cycles of outpatient maintenance therapy. A cycle lasts about 28 days. All participants will be monitored carefully for both side effects and to see if the study treatment is working. Lab tests and exams will be conducted throughout the entire study. In addition, special studies will be done at various time points to try to understand better how the drugs work and which patients are likely to respond best.",[26,27,28],"Acute Myeloid Leukemia, Adult","Acute Myeloid Leukemia Recurrent","Acute Myeloid Leukemia, Relapsed, Adult","RECRUITING","2026-06-29",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2019-11-01",{"date":37,"type":20},"2028-02",{"name":39,"class":40},"University of Maryland, Baltimore","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100527826","phase-1-ciml-nk-cells-with-venetoclax-for-aml-100527826","NCT06152809","CIML NK Cells With Venetoclax for AML","A Phase 1 Study of Cytokine-induced Memory-like (CIML) NK Cells With Venetoclax as Consolidation Therapy in AML","Inclusion Criteria for Trial Enrollment (Screening Visit #1):\n\n* Diagnosis of acute myeloid leukemia (AML)\n* Age ≥ 18 years old\n* At time of screening patient is being treated with HMA(azacitidine or decitabine) + venetoclax therapy and has received at least 1 cycle of HMA (azacitidine or decitabine) + venetoclax. Patients can have received other lines of therapy prior to HMA + venetoclax therapy including prior chemotherapy and any prior stem cell transplant, provided that the stem cell transplant is \\> 6 months prior with no ongoing need for immunosuppressive therapy for active graft-versus-host disease.\n* Presence of molecular risk factors for relapse with continued HMA + venetoclax therapy as defined by any of the following present at the time of diagnosis or start of HMA + venetoclax therapy (these do not need to be present at the time the screening BM biopsy):\n\n  * 2022 ELN adverse risk karyotype: t(6;9)(p23.3;q34.1)\u002FDEK::NUP214; t(v;11q23.3)\u002FKMT2A-rearranged; t(9;22)(q34.1;q11.2)\u002FBCR::ABL1; t(8;16)(p11.2;p13.3)\u002FKAT6A::CREBBP; inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)\u002F GATA2, MECOM(EVI1), t(3q26.2;v)\u002FMECOM(EVI1)-rearranged; -5 or del(5q); -7; Complex karyotype, monosomal karyotype\n  * 2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and\u002For ZRSR2\n  * Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD\u002FTKD\n* ECOG performance status ≤2 (see Appendix A)\n* Participants must meet the following organ function as defined below:\n\n  * Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * creatinine clearance ≥ 45 mL\u002Fmin; calculated by the Cockcroft Gault formula\n  * oxygen saturation ≥ 90% on room air\n  * left ventricular ejection fraction ≥ 40%\n* Negative pregnancy test for women of childbearing potential only.\n* The effects of CIML NK cells and IL-2 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 4 months after the last IL-2 dose administration.\n* Participants with current symptoms of cardiac disease should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)\n* Subjects must be able to swallow pills.\n* No laboratory evidence of ongoing hemolysis in opinion of investigator (demonstration of hemolysis should include a haptoglobin level that is below assay).\n\nExclusion Criteria for Trial Enrollment (Screening visit #1)\n\n* Prior allogeneic stem cell transplant, organ transplant or donor lymphocyte infusion (DLI), CAR-T cell or NK cell therapy\n* Persisting Grade \\> 1 non hematologic toxicity related to prior therapy; however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.\n* Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease disease requiring any steroids \\>\\> the equivalent dose of 10 mg of prednisone or other immunosuppressive therapies at the time of this screening visit (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[e.g., Wegener's Granulomatosis\\]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). Patients with Hashimoto's thyroiditis are eligible to go on study.\n* Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by Flu\u002FCy chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.\n* HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow suppressive therapy.\n* Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after conditioning therapy.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1. History of other malignancy and have had complete remission of disease for at least 2 years; 2. Diagnosed and treated within the past 2 years for: nonmetastatic melanoma, surgically resected (not needing systemic chemotherapy) squamous cell carcinoma of skin and nonmetastatic prostate cancer not needing systemic chemotherapy.\n* History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in study.\n* Participants who are receiving any other investigational agents for this condition\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Prior history of Grade 2 or higher hemolytic anemia (≥ 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.\n\nInclusion Criteria to Start Investigational Treatment Plan (Screening visit #2)\n\n* Patient was eligible for protocol per section 3.1.\n* Repeat bone marrow biopsy at this time shows a complete remission (CR) or complete remission with incomplete count recovery (CRi) or morphologic leukemia free state (MLFS) (\\\u003C 5% blasts) but with presence of measurable residual disease (MRD+). MRD can be determined by either flow cytometry, next generation sequencing or PCR. Patients with only persistent DNMTA, TET2 or ASXL1 mutations will not qualify as MRD+ as these DTA mutations without other comutations are associated with clonal hematopoiesis. OR\n* Repeat bone marrow biopsy at this time shows 5-19% residual myeloblasts in the bone marrow by either bone marrow aspirate or core biopsy.\n* Confirmed haploidentical or fully HLA-matched related donor that is willing and eligible for non-mobilized collection.\n* ECOG performance status ≤2 (see Appendix A)\n* Participants must meet the following laboratory and organ function as defined below:\n\n  * Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * creatinine clearance ≥ 45 mL\u002Fmin; calculated by the Cockcroft Gault formula\n  * oxygen saturation ≥ 90% on room air\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* Negative pregnancy test for women of childbearing potential only.\n* Subjects must be able to swallow pills.\n\nExclusion Criteria to Start Investigational Treatment Plan (Screening visit #2)\n\n* No live vaccines within the last 6 months.\n* No ongoing or active infections.\n* Moderate\u002Fstrong inhibitors of CYP3A except of antifungal medications (such as posaconazole, voriconazole) which the patient is on and the dose of venetoclax has already been adjusted. These are excluded as moderate\u002Fstrong inhibitors of CYP3A induce higher drug levels of venetoclax which in turns carry the risk of CIML NK cell elimination.\n* The presence of donor-specific antibodies (DSAs) with mean fluorescence intensity (MFI) \\>1000 using a standard assay in subjects who do not receive a desensitization protocol prior to and during stem cell transplant.\n\nCriteria to Receive Lymphodepletion on Day -5\n\n* Adequate organ function within 24 hours of lymphodepletion as defined below:\n\n  * Direct bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST (SGOT)\u002FALT (SGPT): ≤ 3 x institutional ULN\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with lymphodepletion, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.\n* No live vaccines within the last 6 months\n\nCriteria to Receive CIML NK Infusion\n\n* Adequate organ function within 24 hours of NK cell infusion as defined below:\n\n  * Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * Creatinine clearance ≥ 45 mL\u002Fmin; calculated by the Cockcroft Gault formula\n* No Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.\n* No systemic steroid therapy (oral or IV) of \\> 10mg prednisone or equivalent dose of other steroid agent on the day of NK cell infusion\n\nIf any of the above criteria are noted at these time points, please discuss with PI the benefits\u002Frisks of proceeding with the CIML infusion and document rationale for course of action taken in study regulatory binder. However, patient may still receive CIML NK infusion if relevant parameters are reviewed and both PI and IND holder agree with proceeding.\n\nIf inclusion\u002Fexclusion criteria are not met on planned day of CIML NK cell infusion, the NK cell infusion may be delayed for up to 24 hours to enable inclusion criteria to be met.\n\nCriteria to Receive Venetoclax\n\n* Adequate organ function within 24 hours of venetoclax initiation as defined below:\n\n  * Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * No Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with venetoclax administration, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, severe ongoing tumor lysis syndrome)\n* No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.\n* No live vaccines within the last 6 months",{"count":50,"type":20},10,[52],"PHASE1","The purpose of this research study is to test the safety and to explore the effectiveness of infusing cytokine- induced memory-like (CIML) natural killer (NK) cells in combination with Interleukin-2 (IL-2) and standard-of-care venetoclax as a treatment for Acute Myeloid Leukemia (AML).\n\nNames of the study therapies involved in this study are:\n\n* Lymphodepleting therapy with Fludarabine and Cyclophosphamide prior to CIML NK cell infusion\n* CIML NK (a cellular therapy)\n* IL-2 (a recombinant, human glycoprotein)\n* Venetoclax (a selective inhibitor of BCL-2 protein)",[55,27,56,57],"Acute Myeloid Leukemia","Leukemia","Leukemia, Myeloid",[55,27,56,57],"2026-03-16",{"date":61,"type":33},"2026-03-18",{"date":63,"type":33},"2024-02-20",{"date":65,"type":20},"2027-11-30",{"name":67,"class":40},"Dana-Farber Cancer Institute",2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":89,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"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":77,"type":20},420,[52],"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.",[55,81,82,83,27,84,85,86,87,88],"Mixed Lineage Leukemia Gene Mutation","Refractory AML","AML With Mutated NPM1","Acute Myeloid Leukemia, in Relapse","NPM1 Mutation","KMT2Ar","Myeloid Sarcoma","Nucleophosmin 1-mutated Acute Myeloid Leukemia",[56,90,91,92,93,94,95,96,97,98,99,100,101,102,103,82,84,104],"Myeloid","AML","Hematological malignancy","KMT2A","NPM1","Menin","Acute Leukemia","Newly diagnosed AML","Untreated AML","venetoclax","cytarabine","daunorubicin","KMT2A-r","NPM1 mutation","quizartinib","2026-03-11",{"date":107,"type":33},"2026-03-13",{"date":109,"type":33},"2023-07-18",{"date":111,"type":20},"2030-04",{"name":113,"class":114},"Kura Oncology, Inc.","INDUSTRY",44]