[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PedAL BCU, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":109},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100418248","phase-1-the-pediatric-acute-leukemia-pedal-screening-trial---a-study-to-test-bone-marrow-and-blood-in-children-with-leukemia-that-has-come-back-after-treatment-or-is-difficult-to-treat---a-leukemia--lymphoma-society-and-childrens-oncology-group-study-100418248",false,"NCT04726241","The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study","Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias","Inclusion Criteria:\n\n* Patients must be less than 22 years of age at the time of study enrollment\n* Patient must have one of the following at the time of study enrollment:\n\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) AML as defined in protocol\n\n    * This includes isolated myeloid sarcoma\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)\n  * Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria:\n\n    * Second or greater B-ALL medullary relapse, excluding KMT2Ar\n    * Any first or greater B-ALL medullary relapse involving KMT2Ar\n    * Any first or greater T-ALL medullary relapse with or without KMT2Ar\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) treatment-related AML (t-AML)\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)\n\n    * Note: Relapsed\u002Frefractory disease includes stable disease, progressive disease, and disease relapse.\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)\n\n    * Note: Relapsed\u002Frefractory disease includes stable disease, progressive disease, and disease relapse.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","ALL","22 Years",{"count":19,"type":20},960,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.",[27,28,29,30,31,32,33,34],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Acute Myeloid Leukemia Post Cytotoxic Therapy","Juvenile Myelomonocytic Leukemia","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndrome","Myelodysplastic Syndrome Post Cytotoxic Therapy","Myeloid Leukemia Associated With Down Syndrome","RECRUITING","2026-06-16",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2022-04-18",{"date":43,"type":20},"2030-12-31",{"name":45,"class":46},"PedAL BCU, LLC","OTHER",183,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100453322","phase-3-venetoclax-in-children-with-relapsed-acute-myeloid-leukemia-aml-100453322","NCT05183035","Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)","A Randomized Phase 3 Trial of Fludarabine\u002FCytarabine\u002FGemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML","Inclusion Criteria\n\n* Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101\u002FAPAL2020D. (This is only applicable for participants in USA\u002FCanada\u002FAustralia\u002FNew Zealand sites\u002FBlood Cancer United territory).\n* Participants must be ≥ 29 days of age and ≤ 21 years of age at enrollment.\n* Participants must have one of the following:\n\n  1. Children, adolescents, and young adults with AML without demonstrated FLT3\u002Finternal tandem duplication (ITD) mutation. Ideally, the status of the mutation needs to be proven in the current relapse. Nevertheless, patients with previous FLT3\u002FITD negative test from prior lines can be included based on local results in order to not delay the start of treatment.\n  2. And participants must have AML which is either:\n\n     * Untreated second relapse, in participants who are sufficiently fit to undergo another round of intensive chemotherapy, or\n     * Untreated first relapse, in participants who cannot tolerate additional anthracycline containing chemotherapy per investigator discretion.\n* Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score).\n* Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to start of protocol treatment:\n\n  1. Cytotoxic chemotherapy: Must not have received cytotoxic chemotherapy within 14 days prior to start of protocol treatment, except for corticosteroids, low dose cytarabine or hydroxyurea that can be given up to 24 hours prior to start of protocol treatment.\n  2. Intrathecal cytotoxic therapy: No wash-out time is required for participants having received any combination of intrathecal cytarabine, methotrexate, and\u002For hydrocortisone.\n  3. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate before start of protocol treatment. For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before start of protocol treatment. Any toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.\n  4. Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors) before start of protocol treatment.\n  5. Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥7 days for short-acting growth factor before start of protocol treatment.\n  6. Radiation therapy (RT) (before start of protocol treatment):\n\n     * ≥ 14 days have elapsed for local palliative RT (small port);\n     * ≥ 84 days must have elapsed if prior craniospinal RT or if ≥ 50% radiation of pelvis;\n     * ≥ 42 days must have elapsed if other substantial bone marrow (BM) radiation.\n  7. Stem Cell Infusions (before start of protocol treatment):\n\n     * ≥ 84 days since allogeneic (non-autologous) bone marrow or stem cell transplant (with or without total body irradiation \\[TBI\\]) or boost infusion (any stem cell product; not including donor lymphocyte infusion \\[DLI\\]);\n     * No evidence of active graft versus host disease (GVHD).\n  8. Participants who are receiving cyclosporine, tacrolimus or other agents to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. Participants must be off medications to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant for at least 14 days prior to enrollment.\n  9. Cellular Therapy: ≥ 42 days after the completion of donor lymphocyte infusion (DLI) or any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.) before start of protocol treatment.\n  10. Participants with prior exposure to venetoclax are eligible in this trial.\n* Adequate organ function:\n\n  1. Adequate Renal Function defined as:\n\n     * Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60ml\u002Fmin\u002F1.73 m\\^2, or\n     * Normal serum creatinine based on age\u002Fsex\n  2. Adequate Liver Function defined as:\n\n     * Direct bilirubin \\\u003C 1.5 x upper limit of normal (ULN), and\n     * Alkaline phosphatase ≤ 2.5 x ULN, and\n     * Serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT) ≤ 2.5 x ULN. If higher transaminases outside these ranges (up to 5x ULN) are due to a radiographically identifiable leukemia infiltrate, the participant will remain eligible. Transaminase elevation up to 5x ULN is also allowed in case of steatosis on echography.\n  3. Cardiac performance: Minimum cardiac function defined as:\n\n     * No history of congestive heart failure in need of medical treatment\n     * No pre-treatment diminished left ventricular function on echocardiography (shortening fraction \\[SF\\] \\\u003C 25% or ejection fraction \\[EF\\] \\\u003C 40%)\n     * No signs of congestive heart failure at presentation of relapse.\n* Participant, parent or guardian must sign and date informed consent and pediatric assent (when required), prior to the initiation of screening or study specific procedures, according to local law and legislation.\n\nExclusion Criteria\n\n* Participants who in the opinion of the investigator may not be able to comply with the study requirements of the study, are not eligible.\n* Participants with Down syndrome.\n* Participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML).\n* Participants with isolated CNS3 disease or symptomatic CNS3 disease.\n* Participants with malabsorption syndrome or any other condition that precludes enteral administration of venetoclax.\n* Participants who are currently receiving an investigational drug other than those specified for this study.\n* Participants with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known congenital bone marrow failure syndrome.\n* Participants with known prior allergy to any of the medications used in protocol therapy.\n* Participants with documented active, uncontrolled infection at the time of study entry.\n* Known hepatitis C virus (HCV), hepatitis B virus (HBV) (known positive hepatitis B virus (HBV) surface antigen (HBsAg) results), or human immunodeficiency virus (HIV) infection.\n* Concomitant Medications\n\n  * Participants who have received strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of study treatment.\n  * Participants who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days of the start of study treatment.\n  * Participants who have hypersensitivity to the active substance or to any of the excipients listed in summary of product characteristics (SPC).\n* Pregnancy or Breast-Feeding:\n\n  * Participants who are pregnant or breast-feeding.\n  * Participants of reproductive potential may not participate unless they have agreed to use a highly effective contraceptive method per Clinical Trial Facilitation Group (CTFG) guidelines for the duration of study therapy and at least 30 days after last dose of venetoclax, or 7 months after gemtuzumab ozogamicin treatment, or for 6 months after the completion of all study therapy, whichever is longer.\n  * Male participants must use a condom during intercourse and agree not to father a child or donate sperm during therapy and for the duration of study therapy and at least 30 days after last dose of venetoclax or 4 months after last dose of gemtuzumab ozogamicin, 6 months from the last dose of cytarabine, or 90-days after last exposure to any other chemotherapy, whichever is longer.\n\nAdditional criteria to receive a gemtuzumab ozogamicin infusion:\n\nGemtuzumab ozogamicin should not be given:\n\n* to participants with history of veno-occlusive disease (VOD)\u002FSinusoidal obstruction syndrome (SOS) grade 3 or 4\n* to participants with CD33 negative leukemic blasts (determined at local lab)\n\nNote that these participants are eligible for the study but will not be treated with gemtuzumab ozogamicin.","29 Days","21 Years",{"count":58,"type":20},130,[60],"PHASE3","A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine\u002Fcytarabine\u002Fgemtuzumab ozogamicin \\[GO\\]) improves survival of children\u002Fadolescents\u002Fyoung adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.",[28],[64,65,66,67,68,69],"Venetoclax","Gemtuzumab Ozogamicin","Fludarabine","Cytarabine","Relapsed refractory","Azacitidine","2026-05-18",{"date":72,"type":39},"2026-05-19",{"date":74,"type":39},"2022-10-01",{"date":76,"type":20},"2031-04",{"name":45,"class":46},90,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":56,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":88},"100544997","phase-1-ziftomenib-in-combination-with-chemotherapy-for-children-with-relapsedrefractory-acute-leukemia-100544997","NCT06376162","Ziftomenib in Combination With Chemotherapy for Children With Relapsed\u002FRefractory Acute Leukemia","A Phase 1 Trial of Menin-inhibitor Ziftomenib in Combination With Chemotherapy for Children With Relapsed\u002FRefractory KMT2A-r\u002FNUP98-r\u002FNPM1-m Acute Leukemia","Inclusion Criteria:\n\n* Age: 0-21 years (and at least 5 kg body weight), with a minimum of 80% of participants under 18 years of age.\n* Diagnosis: KMT2A-r, NPM1-m, or NUP98-r acute leukemia in first or greater relapse or refractory to standard (re-) induction treatment (including HSCT). Please note that genetic alteration must be confirmed by the central laboratory, or the participant will discontinue protocol therapy.\n* Eligible participants also must fulfill one of the following conditions:\n\n  1. Bone marrow relapse is defined as:\n\n     1. A single bone marrow sample showing ≥ 5% leukemic blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing, or other molecular method.\n\n        * a single bone marrow sample with at least two tests showing ≥ 1% leukemic blasts, examples of tests (confirmed by central lab) include: Flow cytometry showing leukemia ≥ 1% by multiparameter flow cytometry (MFC) confirmed by central lab.\n        * Karyotypic abnormality as confirmed by central cytogenetic review.\n        * FISH abnormality identical to one present at diagnosis (must be above level of sensitivity of specific FISH probe; central cytogenetic review required).\n        * Polymerase chain reaction (PCR) or next generation sequencing (NGS)-based demonstration of validated leukemogenic lesion (e.g., fusion, mutation) in a Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory that matches initial diagnosis and is quantifiable as ≥1% confirmed by central lab.\n     2. Participants with combined extramedullary and bone marrow relapse (defined as above) are eligible.\n     3. Participants with isolated extramedullary disease (EMD) are not eligible. EMD relapse is defined as biopsy-proven extramedullary disease without bone marrow disease after documented complete response (CR) following initial therapy. Participants with isolated central nervous system (CNS) relapse are not eligible. Participants with a combined medullary\u002Fextramedullary relapse, including CNS disease, are eligible.\n     4. Participants with asymptomatic CNS3 disease are eligible if they do not have isolated CNS3 extramedullary relapse.\n     5. For participants unable to undergo bone marrow assessment, a peripheral blood absolute blast count ≥ 1,000 cell\u002Fmicroliter is sufficient to diagnose relapsed or refractory disease and facilitate confirmation of required genetic alterations for protocol therapy.\n  2. Refractory disease\u002Finduction failure:\n\n     1. Acute myeloid leukemia (AML): The bone marrow contains ≥ 1% leukemic blasts by MFC at the end of 2 cycles of induction therapy.\n     2. Acute lymphoblastic leukemia (ALL)\u002Fmixed-phenotype acute leukemia (MPAL)\u002Facute undifferentiated leukemia (AUL): The bone marrow contains ≥ 1% leukemic blasts by MFC at the end of induction and consolidation, or persistent MRD prior HSCT (defined as \\> 0.01%).\n     3. For participants unable to have bone marrow assessed, a peripheral blood absolute blast count ≥ 1,000 cell\u002Fmicroliter is sufficient to diagnose relapsed or refractory disease.\n  3. Molecular refractory disease in infant ALL, defined as MRD \\>0.05% after primary induction and consolidation therapy measured by MFC or PCR.\n* Performance status: Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score). Use ECOG for adult participants (≥18 to 21 years), Karnofsky for participants ≥16 to 18 years of age, and Lansky for participants \\\u003C 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Adequate organ function:\n\n  1. Renal function defined as: Creatinine clearance (CrCl) ≥60 mL\u002Fmin (as measured by a nuclear glomerular filtration rate \\[GFR\\] scan or calculated by the Schwartz formula and normalized to a body surface area of 1.73 m\\^2).\n  2. Liver function defined as:\n\n     1. Direct bilirubin \\\u003C 3 x upper limit of normal (ULN) and Serum glutamic pyruvic transaminase (SGPT) (alanine transaminase \\[ALT\\]) ≤ 5 x ULN.\n     2. If liver abnormality is due to radiographically identifiable leukemia infiltrate, the participant will remain eligible.\n  3. Cardiac function defined as: Pre-treatment left ventricular function on echocardiography: Fractional shortening (FS) ≥ 25% or ejection fraction (EF) ≥ 40%, and no signs of congestive heart failure within 4 weeks before start of screening.\n* Prior therapy: Participants must have recovered from the acute toxic effects of all prior anti-cancer therapy (excluding Grade 2 toxicities that are not considered a safety risk or medically significant toxicity deemed irreversible by the Investigator) and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment.\n\n  1. Cytotoxic chemotherapy: Must not have received within 14 days or within 5 drug half-lives (whichever is longer), of entry onto this study, except for hydroxyurea or corticosteroids. Use of steroids and hydroxyurea for other purposes such as differentiation syndrome, or to premedication to prevent allergic reaction or during anesthesia is allowed.\n  2. Intrathecal cytotoxic therapy: No washout or waiting period is required for participants having received any combination of intrathecal cytarabine, methotrexate, and\u002For hydrocortisone.\n  3. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate. For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before enrollment. Any toxicity related to prior antibody therapy must be recovered back to baseline.\n  4. Interleukins, interferons and cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors).\n  5. Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., peg-filgrastim) or 7 days for short-acting growth factor.\n  6. Radiation therapy (RT): 14 days have elapsed for local palliative RT (small port); ≥ 84 days must have elapsed if prior craniospinal RT or if ≥ 50% radiation of pelvis; ≥ 42 days must have elapsed if other substantial bone marrow (BM) radiation.\n  7. Stem cell infusions:\n\n     1. Participants who have relapsed after allogeneic (non-autologous) BM or stem cell transplant (with or without total body irradiation \\[TBI\\]) or boost infusion (any stem cell product; not including donor lymphocyte infusion \\[DLI\\]) must be at least 84 days post HSCT and without evidence of graft versus host disease (GVHD) of any severity except: the use of topical steroids for cutaneous GVHD is allowed and stable steroid doses less than or equal to 10 mg of prednisone daily is permitted. Prednisone dose must be adjusted for body surface area (BSA) in young children. Physiologic doses of hydrocortisone for participants with adrenal insufficiency is allowed.\n     2. Participants who after relapse and continue to receive cyclosporine, tacrolimus or other agents to treat or prevent either GVHD post BM transplant or organ rejection post-transplant are not eligible for this trial. In the relapse setting, participants must be off medications to treat or prevent either GVHD post BM transplant or organ rejection post-transplant for at least 14 days prior to enrollment. A stable steroid dose as mentioned above is allowed.\n  8. Cellular therapy: ≥ 30 days after the completion of DLI or any type of cellular Therapy (e.g., modified T cells, NK cells, dendritic cells, etc.).\n  9. Prior exposure to a different menin inhibitor: Participants who received previous treatment with a different menin inhibitor are allowed to enrol in the study with the exception of those who experienced a severe adverse event attributable to the strong anti-proliferative\u002Fpro-differentiation effects of other menin inhibitors (such as severe differentiation syndrome). Participants who experienced a severe adverse event, which can directly be attributed to specific effects (e.g., long QT syndrome) observed with other menin inhibitors can participate in the study if they fulfill the inclusion criteria.\n* Informed consent: Written, signed and dated informed consent and pediatric assent (if applicable) according to local law and legislation should be collected before start of any study procedures.\n* Female participants of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment.\n* Female participants with infants must agree not to breastfeed their infants while on this study.\n* Contraception:\n\n  1. Participants of reproductive potential, starting from menarche and onwards, may not participate unless they have agreed to use a highly effective contraceptive method per Clinical Trial Facilitation Group (CTFG) guidelines for the duration of study therapy and for 6 months after the completion of all study therapy. For further guidance please review the CTFG website.\n  2. Male participants must use a condom during intercourse and agree not to father a child or donate sperm during therapy and for the duration of study therapy and for 4 months after the completion of all study therapy.\n* Enrollment APAL2020SC trial (US and Canada only): Participants in the US and Canada must have enrolled in the APAL2020SC trial prior to enrollment in the APAL2020K trial.\n\nExclusion Criteria:\n\n* Participants who in the opinion of the investigator may not be able to comply with the study requirements of the study.\n* Participants with Down syndrome.\n* Participants with EMD are not eligible. EMD relapse is defined as biopsy proven extramedullary disease without bone marrow disease after documented CR following initial therapy.\n* Participants with isolated CNS relapse are not eligible, as well as symptomatic CNS3 disease.\n* Participants with acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).\n* Participants with malabsorption syndrome or any other condition that precludes enteral administration of a menin inhibitor.\n* Concomitant therapy: Gastric pH has great influence on absorption of ziftomenib; therefore, the use of proton pump inhibitors is prohibited, if necessary H2 Blockers may provide an alternative treatment option.\n* Participants who are currently receiving another investigational drug.\n* Participants with any known congenital bone marrow failure syndrome.\n* Participants with known prior allergy to any of the medications used in protocol therapy.\n* Participants with documented active, uncontrolled infection at the time of study entry.\n* Active\u002Funcontrolled known human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) and hepatitis C virus (HCV). Note: HIV testing does not need to be conducted at screening unless it is required per local guidelines or institutional standard.\n* Post menarche female participants with positive pregnancy test, and a lactating female participant.\n* Participant has a pre-existing disorder predisposing the participant to a serious or life-threatening infection (e.g., cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder, or cytopenia not related to the leukemia or its treatment).\n* Participants must not be receiving other investigational medications (defined as medicinal products not yet approved for any indications, including alternative\u002Fherbal therapies) within 30 days of first dose of study drug or while on study.\n* Significant congenital cardiovascular disease including, but not limited to conditions such as long QT syndrome, fundamental uncorrected cardiac defect (e.g., coarctation of the aorta) that poses a significant risk to the participant (ventricular septal defect or atrial septal defect are considered non-significant).\n* Underlying medical condition that, in the Principal Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or AEs.\n* For fludarabine and cytarabine: Hypersensitivity to the active substance or to any of the excipients.\n* Recent live vaccinations for at least 6 months.","0 Years",{"count":88,"type":20},20,[23],"The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK).",[92,93,94],"Relapsed\u002FRefractory KMT2A-r Acute Leukemia","Relapsed\u002FRefractory NUP98-r Acute Leukemia","Relapsed\u002FRefractory NPM1-m Acute Leukemia",[96,97,98,99,100],"Ziftomenib","Acute leukemia","KMT2A-r","NUP98-r","NPM1-m","2025-10-17",{"date":103,"type":39},"2025-10-20",{"date":105,"type":39},"2025-03-18",{"date":107,"type":20},"2027-01",{"name":45,"class":46},""]