[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kmt2a-rearranged\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kmt2a-rearranged":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100614749","phase-1-a-phase-ib-trial-of-subcutaneous-blinatumomab-in-combination-with-revumenib-for-patients-with-kmt2a-rearranged-acute-lymphoblastic-leukemia-100614749",false,"NCT07283640","A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia","Eligibility Criteria\n\n• The following groups of participants will be eligible:\n\n* Participants \\> 18 years of age with relapsed and\u002For refractory (defined as \\>5% blasts in the peripheral blood or bone marrow) KMT2A-r B-cell ALL or\n* Participants \\>18 years of age with persistent measurable residual disease by flow cytometry or next generation sequencing KMT2A-r B-cell ALL or\n* Newly diagnosed participants with KMT2A-r B-cell ALL \\> 60 years old or unfit for intensive chemotherapy\n\nUnfit for intensive chemotherapy defined as:\n\n* ECOG \\>2\n* Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction \\\u003C50%, or chronic stable angina)\n* Severe pulmonary disorder (e.g., DLCO \\\u003C65% or FEV1 \\\u003C65%)\n* Creatinine clearance \\\u003C45 ml\u002Fmin\n* Hepatic disorder with total bilirubin 1.5 x upper limit of normal\n* Performance status \\\u003C2 per ECOG scale (for R\u002FR participants)\n* Adequate liver function as defined by the following criteria:\n\n  * Total serum bilirubin \\\u003C1.5 x upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 x ULN\n* Adequate pancreatic function as define by serum lipase and amylase \\\u003C 1.5 x ULN\n* For females of childbearing potential, a negative pregnancy test must be documented (negative serum pregnancy test performed at the time of screening and negative serum or urine pregnancy test prior to the first dose of study drug)\n* The effects of blinatumomab and revumenib on the developing human fetus are unknown. For this reason and because menin inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, 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. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of blinatumomab and revumenib administration. Males must also agree to refrain from sperm donation during this time period.\n* Adequate cardiac function as assessed clinically by history and physical examination with an ejection fraction of \\>50% by echocardiogram or multigated acquisition (MUGA) scan\n* White blood cell (WBC) count below 25,000\u002FuL at the time of enrollment. Participants may receive cytoreduction with dexamethasone and\u002For cyclophosphamide for cytoreduction\n* Estimated glomerular filtration rate (GFR) based on local institutional practice for age appropriate determination by Cockcroft Gault formular for adults, with a GFR\\>60 ml\u002Fmin\u002F1.73m2\n* For participants having previously received stem cell transplant, at least 60 days must have elapsed, and for prior donor lymphocyte infusion, at least 4 weeks must have elapsed\n* For participants having previously received immunotherapy, at least 60 days must have passed\n* Weight of at least 40 kg\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Active serious infection not controlled by oral or IV antibiotics\n* Active secondary malignancy other than skin cancer (basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year\n* Participants with psychiatric illness that would limit compliance with study requirements\n* Untreated CNS disease. Participants with controlled CNS disease may be included (as defined by being asymptomatic and having CNS cleared of leukemic involvement)\n* Detectable HIV viral load within the previous 6 months. Participants with a known history of HIV must have viral load testing prior to study enrollment.\n* Any of the following within 6 months prior to study entry: myocardial infarction, congestive heart failure New York Heart Association Classification Class \\> II, life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack\n* QTc using Friderica's correction (QTcF) \\>450 msec\n* Personal of family history of long QT syndrome\n* Cirrhosis with a Child Pugh score of B or C\n* Participants with active hepatitis B (defined as Hepatitis B surface antigen with detectable Hepatitis B virus DNA by PCR) or hepatitis C infection (defined as presence of detectable Hepatitis C virus RNA by PCR)","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed\u002Frefractory Ph-negative ALL with a KMT2A rearrangement.",[25,26,27,28],"Blinatumomab","Revumenib","Lymphoblastic Leukemia","KMT2A-rearranged","NOT_YET_RECRUITING","2026-06-22",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":19},"2026-11-18",{"date":37,"type":19},"2031-08-31",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":5},"100620262","phase-1-ziftomenib--mezigdomide-in-adolesc-and-adults-w-rr-aml-100620262","NCT07355335","Ziftomenib + Mezigdomide in Adolesc. and Adults w\u002F R\u002FR AML","A Phase 1 Study of Menin-KMT2A Inhibitor Ziftomenib (KO-539) in Combination With Cereblon E3 Ligase Modulator Mezigdomide (CC-92480) in Adolescents and Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Age ≥16 years during dose escalation portion of study, patients must weigh ≥40 kg.\n* Age \\>12 years during dose expansion portion of study, patients must weight ≥40 kg.\n* Diagnosis of AML per the WHO Classification of Hematolymphoid Tumors (5th Edition) with documented KMT2A rearrangement or NPM1 cytoplasmic-type (NPM1c) mutation. KMT2A-rearrangements must be confirmed by FISH or RNA-based fusion calling by a CLIA-certified laboratory. This study will only enroll KMT2A gene rearrangements in which there is a translocation between the N-terminal portion of KMT2A and a fusion partner, and will not include KMT2A partial tandem duplications (PTDs) or other structural alterations of KMT2A. NPM1c mutations must be confirmed by DNA sequencing in a CLIA-certified laboratory. Patients with myeloid sarcoma are eligible only if concurrent bone marrow involvement is present. Patients must have at least 5% bone marrow disease by morphology at the time of study entry.\n* Patients with NPM1 mutated AML must either be FLT3 ITD wild type or have an ITD allelic ratio of \\\u003C0.05 (i.e. not eligible for a targeted FLT3 tyrosine kinase inhibitor).\n* Patients must have relapsed or be refractory to at least one prior line of conventional therapy for AML or MDS-AML.\n* Eastern Cooperative Oncology Group (ECOG) performance status must be 0, 1, or 2; Karnofsky ≥50 for patients ≥16 years of age; and Lansky ≥50 for patients ≥12 to 16 years of age.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Leukocytes \\\u003C25,000\u002FmcL (hydroxyurea, leukapheresis, or single dose of cytarabine 1 g IV are permitted to meet this criterion)\n  * AST(SGOT)\u002FALT(SGPT) ≤5 × institutional ULN and total bilirubin ≤ 2x institutional ULN unless related to leukemic involvement or known Gilbert's syndrome (for bilirubin).\n  * Cardiac LVEF of ≥40%, as measured by echocardiogram or MUGA scan\n  * Glomerular filtration rate (GFR)≥30 mL\u002Fmin\u002F1.73 m2\n* The patient, a parent (if the patient is \\\u003C18 years old), or a legally authorized representative must be able to understand and provide informed consent.\n* Patients of childbearing potential are eligible for the study but must comply with the pregnancy prevention plan for study drugs. See Appendix B for details.\n* Patient's life expectancy attributed to AML must be greater than 3 months.\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. Life expectancy attributed to malignancy other than AML must be greater than 24 months. Patients with concurrent malignancy who are receiving chemotherapy or whose disease is uncontrolled or progressing are not eligible.\n\nExclusion Criteria:\n\n* AML diagnosis without KMT2A-rearrangement or NPM1-mutation. KMT2A-PTD patients and patients with KMT2A alterations other than translocations are excluded.\n* Active central nervous system (CNS) involvement by AML (i.e., CNS-2 or CNS-3 disease). Previously treated CNS disease or those receiving prophylactic intrathecal chemotherapy per institutional standard is allowed.\n* Myeloid sarcoma or extramedullary disease without bone marrow disease.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1 by the NCI-CTCAE version 5.0) with the exception of alopecia.\n* Participants who are receiving any other investigational agents for this condition.\n* Clinically active HIV disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to mezigdomide (i.e. lenalidomide, thalidomide)\n* Patient received chemotherapy, immunotherapy, radiation therapy, or ancillary therapy that is considered to be investigational \\\u003C7 days prior to the first dose of ziftomenib and mezigdomide, or within 5 drug half-lives prior to the first dose of study drug, whichever is longer.\n* Patients with psychiatric, familial, or geographic factors that may impede ability to provide informed consent, to follow study protocol, or hamper study compliance.\n* Any other significant medical or psychosocial comorbidities that would preclude the patient from participating in the study or would confound interpretation of study results.\n* Patients with the following uncontrolled comorbidities will be excluded: symptomatic congestive heart failure (NYHA class 3 or higher), unstable angina pectoris, serious cardiac arrhythmia as uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia (type 1 NSTEMI), active, uncorrected conduction abnormalities as Mobitz 2 or third degree heart block (not excluded if pacemaker placed), myocardial infarction with evidence of residual abnormalities within 6 months prior to enrollment. An elevation in troponin is not an exclusion criterion if there are no evidence of residual cardiac dysfunction or ongoing ischemic event. Patients with congenital conduction abnormalities as Wolff-Parkinson White, long QT syndrome, or Brugada syndrome may be eligible with consultation of cardiology confirming stability.\n* Mean corrected QT interval corrected for heart rate by Frederica's formula (QTcF)\\>480ms.\n* Patients on dialysis.\n* Patients with active infection that are deemed controlled will be permitted to enroll. Patients with uncontrolled infection may enroll once infection is treated and brought under control.\n* Subjects who have undergone a hematopoietic stem cell transplant (HSCT) within 90 days of the first dose of treatment on study, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD), requiring an equivalent dose of ≥ 0.5mg\u002Fkg\u002Fday of prednisone or therapy beyond systemic corticosteroids. (The use of topical steroids for ongoing skin GVHD is permitted.)\n* Patients who are unable to swallow pills.\n* Patient with gastrointestinal disease or surgery (e.g., gastric bypass surgery) that may significantly alter the absorption of mezigdomide and\u002For other oral study treatment.\n* Proton pump inhibitors and potassium-competitive acid blockers are not permitted due to limited absorption of mezigdomide if the stomach is not acidic; a 7-day washout is required prior to start of study treatment.\n* Has active Hepatitis B or C","12 Years",{"count":51,"type":19},24,[22],"The purpose of this study is to evaluate the safety and tolerability of mezigdomide in combination with ziftomenib in adolescent and adult participants with either KMT2A-rearranged (KMT2A-r) or NPM1-mutant relapsed or refractory acute myeloid leukemia (AML).",[28,55],"NPM1-mutant Refractory or Relapsed AML",[57,58,59],"KMT2A rearrangement","NPM1c mutation","AML","2026-01-20",{"date":62,"type":33},"2026-01-22",{"date":64,"type":19},"2026-07-09",{"date":66,"type":19},"2028-01-01",{"name":68,"class":40},"Massachusetts General Hospital"]