[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukaemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,75,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100604877","phase-1-study-of-azd3632-monotherapy-or-in-combination-with-anticancer-agents-in-participants-with-advanced-haematologic-malignancies-with-kmt2ar-npm1m-or-other-genotypes-associated-with-hox-overexpression-100604877",false,"NCT07155226","Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression","A Modular Phase I\u002FII, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression","MOMENTUM","Key Inclusion Criteria:\n\nCore criteria:\n\n* Adequate organ function.\n* Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nModule 1:\n\n* Advanced haematologic malignancy - a) for dose escalation - diagnosis of acute leukemia or myelodysplastic neoplasia (MDS) and harbouring one of the genetic alterations per local testing associated with upregulation of HOX; b) for Backfill - diagnosis of harbouring a KMT2Ar or NPM1m per local testing.\n* Participants must have measurable disease that is relapsed\u002Frefractory to conventional therapies known to be effective for their disease and not have any available approved therapies.: a) Relapsed and primary refractory acute leukaemia after standard of care therapy including but not limited to 2 cycles of intensive chemotherapy, hypomethylating agent (HMA) monotherapy, or HMA combinations such as HMA\u002Fvenetoclax.; b) Relapsed and primary refractory MDS is defined by ≥ 5% blasts in the bone marrow and\u002For persistence of peripheral blasts after treatment with at least 2 cycles of HMA. Participants ineligible for the treatment with an HMA and without any other standard of care (SoC) options are allowed to enrol; c) White blood cell count below 25,000\u002FμL. Participants may receive cytoreduction per protocol-specified criteria; d) Performance status: Eastern Cooperative Operative Group (ECOG) ≤ 2; e) Life expectancy: ≥ 8 weeks.\n\nModule 2:\n\n* Participants must have measurable disease that is relapsed\u002Frefractory to conventional therapies known to be effective for their disease and not have any available approved therapies.: a) Relapsed and primary refractory acute leukaemia after standard of care therapy including but not limited to 2 cycles of intensive chemotherapy, HMA monotherapy, or HMA combinations such as HMA\u002Fvenetoclax.; b) Relapsed and primary refractory MDS is defined by ≥ 5% blasts in the bone marrow and\u002For persistence of peripheral blasts after treatment with at least 2 cycles of HMA. Participants ineligible for the treatment with an HMA and without any other SoC options are allowed to enrol; c) White blood cell count below 25,000\u002FμL. Participants may receive cytoreduction per protocol-specified criteria; d) Performance status: ECOG ≤ 2; e) Life expectancy: ≥ 8 weeks.\n\nKey Exclusion Criteria:\n\nCore criteria:\n\n* Participants with Burkitt lymphoma\u002Fleukaemia or Acute Promyelocytic Leukaemia.\n* Active testicular or active central nervous system (CNS) (\\> CNS1 or radiographic) involvement by leukaemia.\n* Unresolved treatment-related toxicities Grade ≥ 2 from prior therapy.\n* Abnormal levels of potassium or magnesium prior to first dose of AZD3632.\n\nModule 1:\n\n* Receipt of non-CNS radiation therapy within 2 weeks and of CNS radiation within 8 weeks of the first scheduled dose.\n* Receipt of any investigational or non-investigational anticancer agents, including non-biologic agents, biologic agents and\u002For prior treatment other menin inhibitors (backfill participants only).\n* For nested food effect participants - diagnosis of diabetes mellitus (Type I or Type II).\n\nModule 2:\n\n* Receipt of any non-investigational anticancer agents, including non-biologic agents and\u002For biologic agents or receipt of non-CNS or CNS radiation therapy.\n* Participants for whom treatment with posaconazole is contraindicated per the local prescribing information.","ALL","16 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.",[28,29,30],"Acute Lymphoblastic Leukaemia","Acute Myeloid Leukaemia","Higher-risk Myelodysplastic Syndromes",[32,33,34,35,36],"Myelodysplastic Syndromes","Menin inhibitor","Anti-leukaemic activity","Anti-fungal agent","HOX overexpression.","RECRUITING","2026-06-16",{"date":40,"type":41},"2026-06-17","ACTUAL",{"date":43,"type":41},"2026-01-09",{"date":45,"type":21},"2029-02-15",{"name":47,"class":48},"AstraZeneca","INDUSTRY",30,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100518936","phase-1-safety-study-of-cc312-in-adult-patients-with-relapsedrefractory-cd19-positive-b-cell-hematologic-malignancies-100518936","NCT06037018","Safety Study of CC312 in Adult Patients With Relapsed\u002FRefractory CD19 Positive B-cell Hematologic Malignancies","A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Efficacy of CC312 in Adult Patients With Relapsed\u002FRefractory CD19 Positive B-cell Hematologic Malignancies","Inclusion Criteria:\n\n1. CD19 positive B-cell malignancies confirmed as one of the following: aggressive or indolent B-cell NHL, philadelphia chromosome-positive or -negative B-cell ALL, or B-cell CLL; patient must meet the definition of relapse\u002Frefractory before enrollment.\n2. ECOG (Eastern Cooperative Oncology Group) performance status 0-2, life expectancy \\>3 months；\n3. Clinical laboratory values as specified below during the Screening period.\n\n   * Total bilirubin \\\u003C1.5 ULN, may be elevated up to 3 x ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in the liver or in patients with documented Gilbert's Syndrome;\n   * ALT or AST \\\u003C3ULN, may be elevated up to 5 x ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in liver;\n   * Calculated creatinine clearance \\> 50 mL\u002Fmin (The Cockcroft-Gault formula);\n   * Hemoglobin ≥ 7 g\u002FdL;\n   * Neutrophil count \\> 1,000\u002Fmm3 for B-cell NHL patient;\n   * Platelet count \\> 75,000\u002Fmm3 for B-cell NHL patient;\n   * B-ALL patients must have peripheral blast count ≤ 30,000\u002F mm3 prior to first dose of CC312.\n   * Prothrombin time-international normalized ratio (PT-INR) ≤ 1.5ULN.\n4. Female patients of childbearing potential or male patients with a partner of childbearing potential must use one or more contraception methods from screening and continued during study treatment until 3 months after the last dose;\n5. Ability to understand and willingness to provide written informed consent and to comply with scheduled visits and study procedures.\n\nExclusion Criteria:\n\n1. Systemic anticancer therapy within 5 half-lives of the agent or attending clinical trials 4 weeks prior to beginning CC312;\n2. Treatment with radiotherapy within 2 weeks before the study entry;\n3. Treatment with CAR-T within 3 months before the study entry;\n4. Active serious infection requiring antibiotics within 14 days before study entry;\n5. Patients with prior treatment with anti-CD19 directed therapies are eligible only if their tumor cells have been shown to express CD19 after completing the CD19-directed therapy;\n6. Patients with brain metastases or other significant neurological conditions, except for brain metastases which are asymptomatic and radiologically stable without need for steroids for 2 weeks before the first dose of CC312;\n7. Treatment with corticosteroids (\\>10mg daily prednisone or equivalent) or immunosuppressive medication ≤ 7 days before the first dose of CC312, with the following exceptions:\n\n   * Topical, ocular, intra-articular, intranasal, or inhalational corticosteroids;\n   * Use of dexamethasone to reduce peripheral blast counts in ALL;\n8. Vaccination with a live virus vaccine within 4 weeks prior to the study enrollment;\n9. Current autoimmune disease or history of autoimmune disease with potential CNS involvement;\n10. Known to be allergic to protein drugs or recombinant proteins or excipients in the CC312 drug formulation. Patients who experienced Grade 3 reactions that lasted \\\u003C 24h may be eligible after discussion with investigator；\n11. Except for the tolerable events determined by the investigator, any toxic effects of the prior therapy which have not resolved to Grade 1 (CTCAE v5.0);\n12. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse;\n13. Cerebrovascular accident (CVA), Transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, or New York Heart Association (NYHA) class III or IV heart failure occurring within \\\u003C6 months of study entry; uncontrolled arrhythmia within \\\u003C 3 months of study entry. Patients with rate-controlled arrhythmias may be eligible for study entry at discretion of the Investigator.;\n14. Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 2 weeks prior to screening; wound must be fully healed (minor surgical procedures such as catheter placement are not exclusionary criteria);\n15. Existence of congenital long QT syndrome, QTcF \\> 450 msec (for male) or 470 msec (for female), use of cardiac pacemaker, left ventricular ejection fraction (LVEF) \\\u003C50%, clinically significant arrhythmia that requires intervention, cardiac troponin I or T \\> 2.0 ULN, poorly controlled diabetes (HbA1c \\> 9%), hypertension (systolic pressure \\> 160 mmHg or diastolic pressure \\> 100mmHg), or other medical conditions as determined by the Investigator. Patients with stable atrial fibrillation or flutter are eligible for study entry at the discretion of the Investigator;\n16. Any other serious underlying medical (e.g. active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the Investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk for treatmentrelated complications;\n17. Concurrent malignancy \\\u003C 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or \\\u003C T1 urothelial carcinoma. Patients with prostate cancer that is under active surveillance are eligible.;\n18. Pregnant or nursing women.;\n19. Active hepatitis B：HBsAg positive and HBV-DNA\\>ULN; Active hepatitis C：HCV-Ab positive and HCV-RNA\\>ULN；\n20. Known HIV infection；\n21. B-NHL patient that received autologous stem cell transplant 6 months prior to study screening, or historically received organ or allogeneic stem cell\u002Fbone marrow transplant;\n22. B-ALL patients that received transplantation treatment within 3 months prior to enrollment in the study.;\n23. Subjects who in the judgement of the Investigator are not suited to participate in this trial.","18 Years",{"count":59,"type":21},44,[24],"This is a Phase 1, open-label, dose-escalation study to evaluate the safety, PK, PD and immunogenicity of CC312 following intravenous doses of CC312 in patients with relapsed and refractory (r\u002Fr) CD19 expressing B-cell non-Hodgkin lymphoma and B-cell lymphocytic leukemia.",[63,28,64],"Non-hodgkin Lymphoma","Chronic Lymphocytic Leukemia","2025-09-17",{"date":67,"type":41},"2025-09-22",{"date":69,"type":41},"2023-08-07",{"date":71,"type":21},"2026-03",{"name":73,"class":48},"CytoCares Inc",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":92,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100543416","phase-2-intestinal-microbiota-transplant-prior-to-allogeneic-stem-cell-transplant-mast-trial-100543416","NCT06355583","Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial","MAST","Inclusion Criteria:\n\n1. \\- Patients aged 18 years and over with a morphological documented diagnosis of ALL, acute myeloid leukemia (AML), AL of ambiguous lineage, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and CML in blast phase (Appendix 2) who are deemed fit for allogenic HCT with one of the following disease characteristics: ALL, AML, AL of ambiguous lineage\n\n   * Patients in first complete remission (CR1) or second complete remission (CR2) including complete remission with incomplete blood count recovery with \\\u003C 5% blasts (Appendix 2)\n   * Secondary leukaemia (defined as previous history of MDS, antecedent haematological disease or chemotherapy exposure) in CR1 or CR2 defined as \\\u003C 5% blasts (Appendix 2) MDS and CMML\n   * Patients with advanced or high risk MDS with an International Prognostic Scoring System (IPSS-M) moderate high or higher including intermediate or high risk CMML who have \\\u003C 5% blasts at the time of randomisation (Appendix 2) CML in blast phase\n   * Patients with Philadelphia or BCR:ABL1 positive chronic myeloid leukaemia (CML) in blast phase defined by the presence of ≥ 20% blasts in blood or bone marrow who have achieved second chronic phase with \\\u003C 5% blasts (Appendix 2).\n2. Patients must have completed minimum of two cycles of intensive chemotherapy prior to trial enrolment (Appendix 1)\n3. Patients must have received broad-spectrum antibiotics within 3 months prior to trial enrolment\n4. Patients must be considered suitable\u002Ffit to undergo allogeneic hematopoietic cell transplantation (HCT) as clinically judged by the Local investigator\n5. Patients with an Karnofsky performance status score 60 or above (Appendix 3)\n6. Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must use appropriate, highly effective, contraception from the point of commencing therapy until 6 months after treatment\n7. Patients have given written informed consent\n8. Patients willing and able to comply with scheduled study visits and laboratory tests\n\nExclusion Criteria:\n\n1. Patients with contraindications to receiving allogeneic HCT.\n2. Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment.\n3. Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period.\n4. Patients with renal or hepatic impairment as clinically judged by the Local Investigator.\n5. Patients with active infection, HIV-positive or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV).\n6. Patients with a concurrent active malignancy or a prior malignancy, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ, incidental histologic finding of prostate cancer (T1a or T1b using the tumour, node, metastasis (TNM) clinical staging system), previous MDS, CMML, Myeloproliferative neoplasms (MPN) resulting in secondary AML. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent \\\u003C 5 years previously will not be allowed.\n7. Swallowing difficulties that may preclude safe use of IMT capsules.\n8. Administration of IMT within 3 months prior to enrolment (probiotic administration prior to enrolment is allowed but should be recorded at screening).\n9. Patients taking probiotics after enrolment to the trial.\n10. Gastrointestinal disorders and diseases, including delayed gastric emptying, coeliac disease, cystic fibrosis, inflammatory bowel disease, irritable bowel syndrome, chronic diarrhoea, and colonic perforation or fistula.\n11. Any autoimmune disease requiring, or that may require, systemic treatment with steroids and\u002For other immunosuppressants\u002Fimmunomodulators.\n12. Significant bleeding disorder (ALL, AML, AL of ambiguous lineage, MDS, CMML, and CML satisfying inclusion criteria are not excluded).\n13. Anaphylactic food allergy.\n14. Requirement for vasopressors.\n15. Valvular heart disease or known structural defects of the heart.\n16. Known severe allergy to capsule components.",{"count":83,"type":21},50,[25],"The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant.\n\nThe main questions it aims to answer are:\n\n* Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed via patient perspective questionnaires\n* Changes in gut microbiome diversity across all timepoints\n* Markers of general health, infective\u002Fmicrobiological and haematological outcomes including, days of fever, admission to intensive care unit, survival, non-relapsed mortality, and incidence of graft-versus-host disease across all time points measured.\n\nParticipants will be asked at their routine follow up visits to,\n\n* Provide stool, urine and blood samples at the scheduled study visits\n* Complete questionnaires at selected visits\n* Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant (+\u002F-3 days)\n\nResearchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity.",[28,87,88,89,90,91],"Acute Leukemia of Ambiguous Lineage","Chronic Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Myelodysplastic Syndrome","Acute Myeloid Leukemia",[80],"2025-04-14",{"date":95,"type":41},"2025-04-17",{"date":97,"type":41},"2024-05-01",{"date":99,"type":21},"2027-05-01",{"name":101,"class":102},"Imperial College London","OTHER",8,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":110,"maxAge":57,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100205295","phase-2-allogeneic-stem-cell-transplantation-for-children-and-adolescents-with-acute-lymphoblastic-leukaemia-100205295","NCT01949129","Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia","Inclusion Criteria:\n\nPatients with ALL (except for patients with B-ALL) who fulfil the following criteria:\n\n* age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years\n* indication for allogeneic HSCT\n* complete remission (CR) before HSCT\n* written consent of the parents (legal guardian) and, if necessary, the minor patient via \"Informed Consent Form\"\n* no pregnancy\n* no secondary malignancy\n* no previous HSCT\n* HSCT is performed in a study participating centre\n\nExclusion Criteria:\n\n* patients who do not fulfil the inclusion criteria\n* Non Hodgkin-Lymphoma\n* the whole protocol or essential parts are declined either by patient himself\u002Fherself or the respective legal guardian\n* no consent is given for saving and propagation of anonymous medical data for study reasons\n* severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)\n* Karnofsky \u002F Lansky score \\\u003C 50%\n* subjects unwilling or unable to comply with the study procedures","1 Month",{"count":112,"type":21},1800,[25,114],"PHASE3","The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen.\n\nThe stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.",[28],[118,119,120],"stem cell transplantation","children and adolescents","high risk acute lymphoblastic leukaemia","2024-01-12",{"date":123,"type":41},"2024-01-16",{"date":125,"type":4},"2013-04",{"date":127,"type":21},"2030-04",{"name":129,"class":102},"St. Anna Kinderkrebsforschung",119]