[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pediatric-relapsed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pediatric-relapsed":29},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100644426","prospective-observational-study-of-outcomes-after-gemcitabine-docetaxel-melphalan-and-carboplatin-with-autologous-stem-cell-transplantation-in-pediatric-relapsedrefractory-germ-cell-tumors-100644426",false,"NCT07662018","Prospective Observational Study of Outcomes After Gemcitabine, Docetaxel, Melphalan, and Carboplatin With Autologous Stem Cell Transplantation in Pediatric Relapsed\u002FRefractory Germ Cell Tumors","Inclusion Criteria\n\n* Male or female participants, greater than 1 month of age up to 21 years old. Neonates (birth to 1 month of age) will not be enrolled on this protocol.\n* Participants with relapsed\u002Frefractory seminomatous or nonseminomatous GCT who undergo an autologous stem cell transplantation (ASCT) with conditioning therapy including gemcitabine, docetaxel, melphalan, carboplatin (GemDMC) for germ cell tumors\n* As part of our analysis, we will also include participants aged 0-21 years old who have previously underwent ASCT with GemDMC\n* Participants who receive the following regimen:\n\nHigh dose chemotherapy (HDC) course #1:\n\nGemcitabine\u002FDocetaxel\u002FMelphalan\u002FCarboplatin D-6 Admission and start hydration D-5 Gemcitabine 1,500 mg\u002Fm2 IV Docetaxel 275 mg\u002Fm2 IV D-4 Gemcitabine 1,500 mg\u002Fm2 IV Melphalan 20 mg\u002Fm2 IV Carboplatin 250 mg\u002Fm2 IV D-3 Gemcitabine 1,500 mg\u002Fm2 IV Melphalan 20 mg\u002Fm2 IV Carboplatin 250 mg\u002Fm2 IV D-2 Gemcitabine 1,500 mg\u002Fm2 IV Melphalan 20 mg\u002Fm2 IV Carboplatin 250 mg\u002Fm2 IV D-1 Rest D0 Stem Cell infusion\n\nFollowed by HDC course #2 consisting of:\n\nHigh-dose course #2: Carboplatin\u002FEtoposide D-6 Admission and start hydration D-5 to -3 Etoposide 750 mg\u002Fm2 IV Carboplatin 700 mg\u002Fm2 IV D-2 Rest D-1 Rest D0 Stem Cell infusion\n\nExclusion Criteria\n\n* Participants who do not or did not receive GemDMC as part of the conditioning regimen for an ASCT are not eligible for this study","ALL","21 Years",{"count":18,"type":19},30,"ESTIMATED","OBSERVATIONAL","To collect information about treatment outcomes in pediatric and adolescent patients with relapsed\u002Frefractory germ cells tumors who receive GemDMC with an ASCT.",[23,24,25,26,27,28,29,30],"Prospective Observational Study","Gemcitabine","Docetaxel","Melphalan","Carboplatin","Stem Cell Transplantation","Pediatric Relapsed","Refractory Germ","RECRUITING","2026-06-17",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":35},"2026-06-05",{"date":39,"type":19},"2033-12-31",{"name":41,"class":42},"M.D. Anderson Cancer Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":16,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100546598","phase-1-a-phase-i-study-investigating-the-combination-of-the-ziftomenib-venetoclax-and-azacitidine-in-pediatric-relapsed-and-refractory-acute-leukemias-100546598","NCT06397027","A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias","Inclusion Criteria:\n\n1. Age ≥ 2 year to 21 years\n2. ECOG performance status of ≤ 2.\n3. Relapsed\u002Frefractory: AML60, Mixed phenotype acute leukemia61 (MPAL), ALL61, Acute leukemia of ambiguous lineage (ALAL)62 patients with KMT2A-r, NPM1-m, NUP98-r, or HOX pathway mutation as detailed in background section\n\n   a. ≥5% leukemic blasts in the bone marrow:\n4. WBC must be below 25 K\u002FµL at time of enrollment. Participants may receive cytoreduction prior to enrollment.\n5. Baseline ejection fraction must be \\> 40%.\n6. Adequate hepatic function (direct bilirubin \\\u003C 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and\u002For ALT \\\u003C 5x ULN unless considered due to leukemic involvement, in which case direct bilirubin \\\u003C 3x ULN or AST and\u002For ALT \\\u003C 5x ULN will be considered eligible).\n7. Adequate renal function (creatinine clearance ≥ 30 mL\u002Fmin) unless related to disease. (Justification on page 11)\n8. In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy (whichever is shorter). Oral hydroxyurea and\u002For cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI. Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.\n9. Unless surgically or biologically sterile: Women of childbearing potential must agree to adequate methods of contraception during the study and at least 3 months for males, and 6 months for females, after the last treatment.\n\nExclusion Criteria:\n\n1. Participants who weigh less than 10kg.\n2. Participants with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.\n3. The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea for patients with rapidly proliferative disease or for control of counts during differentiation syndrome. (3) use of steroids for treatment of differentiation syndrome.\n4. Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n5. Participants with a concurrent active malignancy under treatment.\n6. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or active\u002Funcontrolled HIV infection, AIDS, or currently taking contraindicated medications for HIV control.\n7. Female participants who are pregnant or breast-feeding.\n8. Participant has an active uncontrolled infection.\n9. Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class .II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n10. Corrected QT interval by Fredericia's formula \\>480 ms on 12-lead electrocardiograms.\n11. History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate.\n12. Clinically active central nervous system (CNS) leukemia.\n13. The use of topical steroids for cutaneous graft-versus-host disease (GVHD) or stable systemic steroid doses less than or equal to 20 mg of prednisone daily are permitted.\n14. Participants with Grade \\> 2 active acute GVHD, moderate or severe limited chronic GVHD, or extensive chronic GVHD of any severity.\n15. Has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the first dose of venetoclax.","2 Years",{"count":52,"type":19},22,"INTERVENTIONAL",[55],"PHASE1","To find the highest safe dose of ziftomenib that can be combined with venetoclax and azacitidine in pediatric participants with acute leukemia that has certain types of genetic mutations (changes).",[58,29],"Refractory Acute Leukemia","2026-01-27",{"date":61,"type":35},"2026-01-29",{"date":63,"type":35},"2024-12-27",{"date":65,"type":19},"2030-12-31",{"name":41,"class":42}]