[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-with-kmt2a-rearrangement\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-with-kmt2a-rearrangement":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100507335","phase-1-a-phase-1b-study-of-menin-inhibitor-sndx--5613-in-combination-with-daunorubicin-and-cytarabine-in-newly-diagnosed-patients-with-acute-myeloid-leukemia-and-npm1-mutatedflt3-wildtype-or-mllkmt2a-rearranged-or-nup98-alterations-disease-100507335",false,"NCT05886049","A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated\u002FFLT3 Wildtype or MLL\u002FKMT2A Rearranged or NUP98 Alterations Disease","A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated\u002FFLT3 Wildtype or MLL\u002FKMT2A Rearranged or NUP98 Alterations Disease","Inclusion Criteria:\n\n* Dose escalation: Patients ages 18-75 years at time of diagnosis with NPM1-mutated\u002FFLT3-ITD wildtype and NPM1-mutated\u002FFLT3-TKD wildtype with high-risk features (adverse risk genetics per European LeukemiaNet \\[ELN\\] 2022 criteria, age ≥ 60 years, or secondary AML defined as either arising from a prior hematological malignancy or therapy-related), MLL (KMT2A) rearranged or NUP98 altered, untreated AML and who are candidates for intensive induction chemotherapy. Patients with CD33+ AML are eligible for this protocol.\n* Dose expansion: Patients ages 18-75 years at time of diagnosis with NPM1-mutated\u002FFLT3-ITD wildtype and NPM1-mutated\u002FFLT3-TKD wildtype (any patient-does not require high-risk features), MLL (KMT2A) rearranged, or NUP98 altered, untreated AML and who are candidates for intensive induction chemotherapy. Patients with CD33+ AML are eligible for this protocol\n* Because no dosing or adverse event data are currently available on the use of SNDX-5613 in combination with daunorubicin and cytarabine in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%). Patients over the age of 65 must have an ECOG performance status of 0-1\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except for patients with Gilbert's syndrome where required to be ≤ 3 x institutional ULN\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional upper limit of normal (ULN)\n* Glomerular filtration rate (GFR) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 (via the Chronic Kidney Disease Epidemiology \\[CKD-EPI\\] glomerular filtration rate estimation)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with 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 Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Ejection fraction \\>= 50% (or \\>= 45% if no evidence of congestive heart failure \\[CHF\\] or other cardiac symptoms) by transthoracic echocardiogram (TTE) or multi-gated acquisition (MUGA) scan\n* White blood cells (WBC) must be \\\u003C 25 x 10\\^9\u002FL. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped within 24 hours of initiation of protocol therapy. Must not have had any signs of leukostasis requiring cytoreduction\n* Female patients of childbearing potential must agree to use 2 forms of contraception from screening visit until 120 days following the last dose of study treatment. Male patients of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from screening visit until 180 days until the last dose of study treatment. They must also refrain from sperm donation from screening visit until 180 days following the last dose of study treatment\n* Patients must have previously untreated AML with no prior treatment other than hydroxyurea or intrathecal chemotherapy for central nervous system (CNS) prophylaxis\u002Ftreatment. No chemotherapy for AML outside of hydroxyurea for treatment of leukostasis or all-trans retinoic acid (ATRA) for initially suspected acute promyelocytic leukemia (APL) (that is ruled out) is allowed\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SNDX-5613, daunorubicin or cytarabine\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Patient must not have received known strong or moderate CYP3A4 inhibitors, or strong CYP3A4 inducers (with the exception of antifungal prophylaxis with azoles) within 7 days of enrollment. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Pregnant women are excluded from this study because SNDX-5613 is a menin-KMT2A inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SNDX-5613, breastfeeding should be discontinued if the mother is treated with SNDX-5613. These potential risks may also apply to other agents used in this study\n* Isolated myeloid sarcoma (i.e., patients must have blood or marrow involvement with AML to enter the study)\n* Acute promyelocytic leukemia (French-American-British \\[FAB\\] M3)\n* Untreated, active central nervous system (CNS) involvement by AML. Patients are allowed to undergoing diagnostic lumbar puncture (LP) with intrathecal chemotherapy while on study\n* Uncontrolled symptomatic disseminated intravascular coagulopathy with active bleeding or signs of thrombosis\n* Patients with Fridericia's correction formula (QTcF) \\>= 450 ms at screening; patients with right, left, or partial bundle branch blocks or a pacemaker who are asymptomatic are eligible regardless of QTC if cleared by cardiology for enrollment in the trial. Any factors that increase the risk of QTc prolongation or risk of arrhythmic event such as congenital long QT syndrome or family history of long QT syndrome\n* Patients who will exceed a lifetime anthracycline exposure of \\> 550 mg\u002Fm\\^2 daunorubicin or equivalent (or \\> 400 mg\u002Fm\\^2 daunorubicin or equivalent in the event of prior mediastinal radiation) if they receive the maximum potential exposure to anthracyclines per protocol (including both induction and reinduction cycles)\n* Patients with any gastrointestinal issue of the upper gastrointestinal (GI) tract that might affect oral drug absorption or ingestion (eg, gastric bypass, gastroparesis, etc)\n* Patients who have cirrhosis with a Child-Pugh score of B or C\n* Patients with Down Syndrome due to higher rates of chemotherapy-associated toxicities, and may have different pharmacokinetics, as well. Toxicities that occur at higher frequencies include cardiotoxicity, a known risk of SNDX-5613 treatment (i.e., QTcF prolongation)\n* Patients with myelodysplastic syndromes (MDS) treated with previous intensive induction regimens similar to 7+3","ALL","18 Years","75 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL\u002FKMT2A gene. SNDX-5613 blocks signals passed from one molecule to another inside cancer cells that are needed for cancer cell survival. Drugs used in chemotherapy, such as daunorubicin 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. Adding SNDX-5613 to the standard chemotherapy treatment may be able to shrink or stabilize the cancer for longer than the standard chemotherapy treatment alone.",[27,28,29,30],"Acute Myeloid Leukemia","Acute Myeloid Leukemia With KMT2A Rearrangement","Acute Myeloid Leukemia With NPM1 Mutation","Secondary Acute Myeloid Leukemia","RECRUITING","2026-06-16",{"date":34,"type":35},"2026-06-17","ACTUAL",{"date":37,"type":35},"2024-06-20",{"date":39,"type":21},"2027-12-31",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",22,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100533189","phase-1-sndx-5613-and-gilteritinib-for-the-treatment-of-relapsed-or-refractory-flt3-mutated-acute-myeloid-leukemia-and-concurrent-mll-rearrangement-or-npm1-mutation-100533189","NCT06222580","SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation","Safety and Efficacy of Dual Menin and FLT3 Inhibition in Patients With Relapsed\u002FRefractory FLT3- Mutated Acute Myeloid Leukemia Containing a Concurrent MLL-Rearrangement or NPM1 Mutation: A Phase I (Ph I) Study of SNDX-5613 + Gilteritinib","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Age ≥ 18 years at the date of signing the informed consent form (ICF)\n* Morphologically confirmed diagnosis of the following based on 2022 World Health Organization (WHO) classification:\n\n  * Relapsed or Refractory Acute Myeloid Leukemia with the following:\n\n    * Refractory disease classified as having received 2 cycles of intensive induction or 2 cycles of hypomethylating agent (HMA) + Venetoclax with persistent disease of ≥ 5% blasts in the bone marrow and\u002For reappearance of peripheral blasts\n  * FLT-3 mutated disease of the ITD or TKD subtype, AND\n  * NPM1 mutation, MLL gene rearrangement and any other mutation that has proven HOXA-MEIS1 overexpression (NUP98, UBTF-TD, MLL-PTD and any others that have supporting literature)\n* Patients must be receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis for at least 24 hours prior to enrollment and while on SNDX-5613 treatment. Patients must not be receiving any other strong CYP3A4 inhibitors\u002Finducers\n* Not suitable for immediate myeloablative\u002Fintensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)\n* Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m\\^2 (estimation based on Modification of Diet in Renal Disease (MDRD) formula, by local laboratory)\n* Adequate cardiac function defined as ejection fraction (EF) of ≥50% by echocardiogram or multigated acquisition (MUGA) scan\n* Patient can communicate with the investigator and has the ability to comply with the requirements of the study procedures\n* Participants of childbearing potential must agree to have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test on the first day of study treatment\n* Participants capable of impregnating others who are having intercourse with people of childbearing potential must agree to abstain from intercourse or have their partner use 2 forms of contraception from the screening visit until 90 days after the last dose of study treatment. They must also refrain from sperm donation from the screening visit until 90 days following the last dose of study treatment\n* Must be able to swallow the study medications\n* Any prior treatment-related toxicities resolved to ≤ grade 1 prior to enrollment, with the exception of ≤ grade 2 neuropathy or alopecia\n* Patients are not currently receiving the following therapies or have discontinued therapy based on the time periods below:\n\n  * Radiation Therapy: At least 60 days from prior total body irradiation (TBI), craniospinal radiation and\u002For ≥ 50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port)\n  * Stem Cell Infusion: At least 60 days must have elapsed from hematopoietic stem cell transplant (HSCT) and at least 4 weeks must have elapsed from donor lymphocyte infusion (DLI)\n  * 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 or other modified T cell therapy\n  * Antileukemia Therapy\\*\\*\\*: At least 14 days, or 5 half-lives, whichever is shorter, since the completion of antileukemic therapy (for example, but not limited to, small molecule or cytotoxic\u002Fmyelosuppressive therapy), with the following exceptions:\n  * Wah-out can be shorter for patients with rapidly progressing disease as determined by the treating investigator\n  * Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea can be continued concomitantly with SNDX-5613, with medical monitor approval. Patients may continue to receive prophylactic intrathecal chemotherapy at any time at the treating physician's discretion\n  * 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\n  * Biologics (e.g., monoclonal antibody therapy): At least 90 days, or 5 half-lives, whichever is shorter, since the completion of therapy with an antineoplastic biologic agent\n  * Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily for patients ≥ 18 years or ≤10 mg\u002Fm\\^2 \u002Fday for patients\n\n    * Prior treatment with gilteritinib is allowed\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia\n* Diagnosis of extra-medullary acute myeloid leukemia (AML) based on WHO 2022 classification or myeloid sarcoma\n* Suspected central nervous system (CNS) involvement. Patients with history of cerebrospinal fluid (CSF) involvement must either have documented CSF clearance prior to treatment initiation or be receiving active treatment for CNS involvement\n* Participants with prior malignancy, except:\n\n  * Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study\n  * Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible\n* Previous known allergy\u002Fsensitivity to components of gilteritinib or SNDX-5613. Prior treatment with gilteritinib is allowed and does not exclude a patient\n* Patient with known human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Individuals with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Fridericia's corrected QT interval (QTcF) \\> 450 msec at time of screening\n* Clinically significant ventricular arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)\n* Uncontrolled intercurrent illness including, but not limited to, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 2 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure\n* Patients with uncontrolled infection will not be enrolled until infection is treated and under control per the principal investigator or their designee\n* Any psychiatric illness that prevents patient from informed consent process\n* Pregnant or breastfeeding at the time of enrollment\n* Patient has a malabsorption syndrome or other condition that precludes an enteral route of administration\n* Patient has history of a cardiovascular, endocrinologic, hepatic, immunologic metabolic, neurologic, psychiatric, pulmonary, renal disease, or any other condition that in the opinion of the investigator would adversely affect his\u002Fher participation in this study or interpretation of study results",{"count":52,"type":21},30,[24],"This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and\u002For effective in treating patients with relapsed\u002Frefractory FLT3 mutated acute myeloid leukemia.",[56,28,29,57,58],"Acute Myeloid Leukemia With FLT3\u002FITD Mutation","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","2026-05-12",{"date":61,"type":35},"2026-05-14",{"date":63,"type":35},"2024-02-20",{"date":65,"type":21},"2027-02-28",{"name":67,"class":68},"Uma Borate","OTHER",4]