[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"precursor-cell-lymphoblastic-leukemia-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:precursor-cell-lymphoblastic-leukemia-lymphoma":271},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,81,106,149,176,199,224,248],{"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":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100239104","phase-1-phase-i-trial-of-turalior-pexidartinib-plx3397-in-children-and-young-adults-with-refractory-leukemias-and-refractory-solid-tumors-including-neurofibromatosis-type-1-nf1-associated-plexiform-neurofibromas-pn-and-tenosynovial-giant-cell-tumor--100239104",false,"NCT02390752","Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...","Phase I Trial of TURALIO (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor (TGCT)","* INCLUSION CRITERIA:\n* Diagnosis:\n\n  * Individuals must have recurrent or refractory solid tumors or acute leukemia (limited to AML or ALL) or have been intolerant of prior therapies, confirmed by the Laboratory of Pathology, NCI, e.g., solid tumors including rhabdomyosarcoma, Ewing sarcoma, soft tissue sarcomas. These may include primary neoplasms of the central nervous system, such as high-grade (WHO grade III-IV) glioma. Individuals with diffuse intrinsic pontine glioma (DIPG) or optic pathway glioma are exempt from histologic verification. For DIPG typical MRI findings must be present which include hypo- or isointense on T1-weighted imaging, hyperintense on FLAIR or T2-weighted imaging, epicenter in the pons in the face of a typical clinical presentation. Optic pathway gliomas are located in the optic pathway and are typically hypo- or iso-intense on T1 and hyperintense on T2-weighted images.\n  * In addition, individuals with NF1 and with malignant peripheral nerve sheath tumor (MPNST).\n\n    * Individuals must have relapsed after or be refractory to effective standard therapies. There are no limits on number of prior therapeutic regimens.\n* Disease status: Individuals with refractory solid tumors including patients with NF1 and MPNST must have evaluable disease, patients with leukemia must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry.\n* Age \\>= 3 and \\\u003C= 35 years of age (must have BSA \\>= 0.55 m\\^2):\n* Ability of subject or Legally Authorized Representative \\[LAR\\] (the parent\u002Fguardian if subject is a minor) to understand and the willingness to sign a written informed consent document.\n* Individuals must be able to swallow capsules.\n* Performance Status: Karnofsky \\>= 50% for patients \\> 16 years of age and Lansky \\>= 50% for patients \\\u003C= 16 years of age. Individuals who are wheelchair bound because of paralysis will be considered \"ambulatory\" when they are up in their wheelchair. Individuals have to be able to travel to the NIH for evaluations.\n* Prior therapy:\n\nIndividuals must have fully recovered (to Grade 1) from the acute toxic effects of all prior anti-cancer therapy.\n\n* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).\n* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.\n* Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines.\n* Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody.\n* XRT: At least 7 days after local palliative XRT (small port); At least 150 days must have elapsed if prior TBI or if \\>= 50% radiation of pelvis; \\>= 14 days from whole brain radiation, craniospinal radiation, or targeted radiation to CNS tumors. At least 42 days must have elapsed if other substantial BM radiation.\n* HSCT: \\>= 56 days from stem cell transplant with no evidence of active graft vs. host disease; must be off immunosuppressive therapy for at least 4 weeks and have no active graft-versus-host disease (GVHD) at the time of entry onto this trial.\n* Surgery: \\>= 14 days from surgery\n* Others: \\>= 7 days from last dose of short active hematopoietic growth factors, i.e. filgrastim, \\>= 14 days for long-acting, i.e. pegfilgrastim.\n* Steroids: Individuals with CNS tumors who are managed with steroids are eligible if they have no worsening neurologic deficits and are on a stable or decreasing dose of corticosteroids for greater than or equal to 7 days prior to registration. Individuals with leukemia receiving corticosteroids or hydroxyurea are eligible provided that the corticosteroids are not being used to manage GVHD and there has been no increase in corticosteroid of hydroxyurea dose for 7 days prior to starting TURALIO(R).\n\n  -Individual must have adequate hematologic, hepatic, and renal function, defined by:\n* Absolute neutrophil count \\>= 1.5 x 10\\^9\u002FL\n* Hemoglobin \\> 10 g\u002FdL\n* Platelet count \\>= 100 x 10\\^9\u002FL\n* AST and ALT \\\u003C= upper limit of normal (ULN)\n* TBil and DBil \\\u003C= ULN with an exception of patients with confirmed Gilbert's syndrome. For patients with confirmed Gilberts syndrome, the TBil should be \\\u003C= 1.5 x ULN\n* Serum creatinine \\\u003C= 1.5 x ULN\n* Exceptions:\n\n  * Cytopenias due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of cytopenia due to disease, based on the results of bone marrow studies.\n  * Known active or chronic human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection, or positive hepatitis B (Hep B) surface antigen. Prior hepatitis infection that has been treated with highly effective therapy with no evidence of residual infection and with normal liver function (ALT, AST, total and direct bilirubin \\\u003C= ULN) is allowed.\n  * Hepatobiliary diseases including biliary tract diseases, autoimmune hepatitis, inflammation, fibrosis, cirrhosis of liver caused by viral, alcohol, or genetic reasons. Gilbert's disease is allowed if TBil is \\\u003C= 1.5 x ULN.\n\n    * Cardiac ejection fraction \\>= 50%, and QTcF \\\u003C 450 ms (male) or \\\u003C470 ms (female) on ECG at Baseline. (Fridericia's Formula: QTcF = (QT)\u002FRR0.33)\n    * Contraception: Women of child-bearing potential must agree to use an effective method of birth control during treatment and for 1 month after receiving their last dose of study drug. Fertile men must also agree to use an acceptable method of birth control while on study drug and for at least one month after last dose.\n\nEXCLUSION CRITERIA:\n\n* Individuals who are pregnant or breast feeding or who become pregnant while enrolled on this trial will be excluded from participation, due to the unknown effects of TURALIO(R) on a growing fetus or newborn child.\n* Ongoing treatment with any other cancer therapy or investigational agent, with the exception of IT chemotherapy for leukemia, when indicated.\n* Individuals who require therapy with warfarin.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active untreated infection.\n* Known active hepatitis A, B, C or HIV infection, chronic Hepatitis B or C, or HIV infection or inactive Hepatitis B carrier.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to TURALIO(R) or other agents used in study.\n* Individuals with PT and\u002For INR higher than or equal to 1.5 times upper limit of normal, unless patients have lupus anticoagulant in which case they are eligible if cleared by hematology.\n* Drugs that strongly inhibit or potentiate CYP3A4, which includes CYP3A4 inducer, UGT inhibitors and acid reducing agents and avoid concomitant use of PPIs:\n\n  * Individuals who have received these drugs within 14 days or within 5 half-lives of the drug (whichever is longer) prior to study initiation will be excluded.","ALL","3 Years","35 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\n\\- Some people with cancer have solid tumors. Others have refractory leukemia. This may not go away after treatment. Researchers want to see if a drug called TURALIO(R) can shrink tumors or stop them from growing.\n\nObjectives:\n\n\\- To find the highest safe dose and side effects of TURALIO(R). To see if it helps treat certain types of cancer.\n\nEligibility:\n\n\\- People ages 3-35 with a solid tumor or leukemia that has returned or not responded to cancer therapies.\n\nDesign:\n\n* Individuals will be screened with:\n* Medical history\n* Physical exam\n* Blood and urine tests\n* Heart tests\n* Scans or other tests of the tumor\n* Individuals will take TURALIO(R) as a capsule once daily for a 28-day cycle. They can do this for up to 2 years.\n* During the study, participants will have many tests and procedures. They include repeats of the screening tests. Individuals will keep a diary of symptoms.\n* Individuals with solid tumors will have scans or x-rays.\n* Individuals with leukemia will have blood tests. They may have a bone marrow sample taken.\n* Some individuals may have a biopsy.\n* When finished taking TURALIO(R), individuals will have follow-up visits. They will repeat the screening tests and note side effects.",[27,28,29,30],"Neurofibroma, Plexiform","Precursor Cell Lymphoblastic Leukemia-Lymphoma","Leukemia, Promyelocytic, Acute","Sarcoma",[32,33,34,35],"Maximum Tolerated Dose","Dose Escalation","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","RECRUITING","2026-06-27",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2015-04-29",{"date":44,"type":21},"2028-12-31",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100633147","virtual-buddy-movement-therapy-for-psychomotor-and-social-development-in-pediatric-oncology-patients-in-remission-100633147","NCT07522905","Virtual Buddy Movement Therapy for Psychomotor and Social Development in Pediatric Oncology Patients in Remission","The Impact of a 12-week Virtual Buddy-movement Therapy on the Psychomotor and Social Development of Pediatric Oncology Patients in Remission","Inclusion Criteria:\n\n* Age: 5-12 years\n* Diagnosis: acute lymphoblastic leukemia in complete remission\n* First-line treatment of acute lymphoblastic leukemia according to the treatment protocol\n* BUDDY - a healthy friend aged 5-12 years\n\nExclusion Criteria:\n\n* Participation in the movement program less than 80%","5 Years","12 Years",{"count":59,"type":21},24,[61],"NA","Acute lymphoblastic leukemia is the most common type of cancer in children diagnosed between the ages of two and five. After cancer treatment, children suffer from fatigue and exhaustion, and thus a decrease in daily physical activity. In addition, lack of physical activity and sports causes a decrease in strength and mobility and affects coordination of movements, proprioceptive perception and balance, which can lead to the occurrence of many injuries. In addition, physical inactivity in children who have survived cancer increases the risk of cardiovascular diseases or causes overweight and obesity. In addition, the separation of children with cancer from their peers harms social, emotional, physical and school indicators of quality of life. The aim of the project is to determine the impact of 12 weeks of buddy-movement therapy on the psychomotor and social development of pediatric cancer patients in remission. The investigators expect a significant improvement in the motor skills of pediatric oncology patients in remission, specifically in fine and gross motor skills, in coordination of both hands, in body coordination, in strength and dexterity. The investigators also assume that after the introduction of 12-week buddy-movement therapy, there will be a significant improvement in the quality of life of pediatric oncology patients in remission, specifically in emotional functioning, in social functioning, in physical functioning and in school functioning. Furthermore, it is anticipated that after the introduction of 12-week buddy-movement therapy, the study will notice significant differences in motor skills between the experimental and control groups. It is also assumed that after the introduction of 12-week buddy-movement therapy, significant differences in quality of life between the experimental and control groups will be observed. The research will involve pediatric oncology patients in remission aged 5 to 12 years with acute lymphoblastic leukemia - ALL, who are treated at the Department of Pediatric Hematology and Oncology of the National Institute of Children's Diseases (NÚDCH). The research participants will undergo an entry and exit examination, including body mass index (BMI; kg\u002Fm\\^2) calculated from weight (kg), height (m), waist circumference (cm), hip circumference (cm), psychomotor examination using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, and quality of life measured by the Pediatric Quality of Life Inventory. They will be divided into a control and experimental group, with the experimental group undergoing a 12-week Buddy-movement therapy focused on the development of psychomotor skills and socialization of participants using Buddy peer support.",[28],[65,66,67,68,69,70],"Pediatric Cancer Survivors","Acute Lymphoblastic Leukemia","Movement Therapy","Psychomotor development","Quality of life","BUDDY","2026-05-01",{"date":73,"type":40},"2026-05-07",{"date":75,"type":40},"2026-04-07",{"date":77,"type":21},"2027-12-31",{"name":79,"class":80},"Comenius University","OTHER",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":48},"100629049","ehealth-mindfulness-based-music-therapy-intervention-for-patients-undergoing-stem-cell-transplantation-100629049","NCT07469592","eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation","Inclusion Criteria:\n\n* ≥ 18 years of age\n* have a primary diagnosis of a hematologic malignancy (e.g., myelodysplastic syndrome \\[MDS\\], acute myeloid leukemia \\[AML\\], acute lymphoblastic leukemia \\[ALL\\], or non Hodgkin's Lymphoma \\[NHL\\])\n* have a treatment plan for a hematopoietic stem cell transplant\n* Speak English or Spanish\n\nExclusion Criteria:\n\n* history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months)\n* severe cognitive impairment (per the short portable mental status questionnaire)\n* hearing impairment\n* active alcohol or substance dependence within the past six months\n* participated in the prior pilot MBMT R61 phase\n* participated in music therapy or mindfulness programs in the past six months","18 Years",{"count":89,"type":21},165,[61],"The goal of this study is to test an electronic health (eHealth) mindfulness-based music therapy intervention to improve health-related quality of life and reduce symptom burden and disease activity in patients undergoing stem cell transplantation.",[93,94,95,28,96],"Stem Cell Transplantation","Myelodysplastic Syndromes","Leukemia, Myeloid, Acute","Lymphoma, Non-Hodgkin","NOT_YET_RECRUITING","2026-04-10",{"date":100,"type":40},"2026-04-13",{"date":39,"type":21},{"date":103,"type":21},"2028-06-30",{"name":105,"class":80},"University of Miami",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":147,"locationsCount":48},"100574945","early-phase-1-cart123-t-cells-in-relapsed-or-refractory-cd123-hematologic-malignancies-a-dose-escalation-phase-i-trial-100574945","NCT06765876","CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial","Safety and Efficacy of Anti-CD123 Chimeric Antigen Receptor-Modified Autologous T Cells (CART123) in Patients With Relapsed\u002FRefractory CD123+ Hematologic Malignancies: A Dose Escalation, Open-Label, Phase I Study","UHKT-CAR123-01","Inclusion Criteria:\n\n1. Patients with AML, MDS-IB2, BPDCN or ALL positive for CD123 antigen, who meet one of disease specific criteria below:\n\n   a) Patients with AML will be eligible if they meet one of the following criteria:\n\n   i) Patient with refractory AML defined as failure to achieve CR or CRi after at least 2 cycles of induction chemotherapy or 1 cycle of high dose salvage regimen or 4 cycles of venetoclax with azacytidine OR\n\n   ii) Second or subsequent relapse of AML OR\n\n   iii) Relapse after allogeneic HSCT.\n\n   b) Patients with ALL will be eligible if they meet one of following criteria:\n\n   i) disease refractory to or relapsed after CAR-19 cell therapy OR\n\n   ii) CD19 negative relapse ineligible for treatment with TKI inhibitors and inotuzumab ozogamicin.\n\n   c) Patients with BPDCN will be eligible if they meet following criteria:\n\n   i) Refractory or relapsing after chemotherapy with or without allogeneic stem cell transplantation.\n\n   d) Patients with MDS-IB2 will be eligible if they meet one of following criteria:\n\n   i) Disease refractory to at least four cycles of azacytidine or progression on azacytidine-based therapy OR\n\n   ii) Disease refractory to induction chemotherapy OR\n\n   iii) Relapse after haematopoietic stem cell transplantation.\n2. CD123 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.\n3. Age between 18 and 70 years.\n4. Patient has a suitable donor for allogeneic hematopoietic stem cell transplantation. Workup and clearance of the donor must be completed before IMP administration.\n5. Patient able to understand and sign informed consent.\n6. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.\n7. Patient for whom there are no standard-of-care treatments available or such treatment options have been exhausted.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the IMP.\n2. Allogeneic HSCT within 3 months prior to IMP administration.\n3. Severe, uncontrolled active infection.\n4. Life expectancy \\\u003C 8 weeks.\n5. Respiratory insufficiency (need for oxygen therapy).\n6. Significant liver impairment: bilirubin \\> 50 µmol\u002FL, AST or ALT \\> 4 times normal upper limit.\n7. Acute kidney injury with serum creatinine \\> 180 µmol\u002FL, oliguria or need for acute dialysis.\n8. Heart failure with LVEF \\\u003C 50% by echocardiography.\n9. Presence of active grade 3 - 4 acute GvHD or severe chronic GvHD.\n10. Serious uncontrolled neurological comorbidity.\n11. Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.\n12. Women: pregnancy or breast-feeding.\n13. Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:\n\n    1. female patients of childbearing potential not willing to use a highly effective method of contraception during the study,\n    2. male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.","70 Years",{"count":116,"type":21},18,[118],"EARLY_PHASE1","Adult patients with refractory or relapsed CD123+ hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or blastic plasmocytoid dentritic cell neoplasm will be recruited in the trial. CART123 cells will be manufatured from blood of each patient. During the production of CAR123 cells, patients may receive appropriate bridging therapy. After cells are produced, participants will undergo a single course of lymphodepleting chemotherapy and receive a single dose of CAR123 T cells. The trial will establish the recommended dose for further studies, either the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD). Patients must be eligible for hematopoietic stem cell transplantation in order to participate in the trial.",[121,28,122,123],"Leukemia, Myeloid, Acute(AML)","Myelodysplastic Syndromes (MDS)","Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",[125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140],"CAR123 T lymphocytes","CART123","CD123+ Hematologic Malignancies","Anti-CD123","Chimeric Antigen Receptor (CAR) T Cells","Autologous T Cells","Hematopoietic Malignancies","Immunotherapy","Personalized Medicine","Biological Therapy","Phase I Clinical Trial","Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia, Refractory","Relapsed Myelodysplastic syndrome","Relapsed Blastic Plasmacytoid Dendritic Cell Neoplasm","Acute Myeloid Leukaemia Recurrent","2026-01-08",{"date":143,"type":40},"2026-01-12",{"date":145,"type":40},"2024-10-23",{"date":44,"type":21},{"name":148,"class":80},"Institute of Hematology and Blood Transfusion, Czech Republic",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":174,"locationsCount":48},"100545838","phase-2-efficacy-and-safety-of-low-dose-chemotherapy-plus-immuno-targeted-drugs-in-newly-diagnosed-adult-ph--b-all-100545838","NCT06387121","Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL","Efficacy and Safety of Low-dose Chemotherapy Combined With Immuno-targeted Drugs in Newly Diagnosed Adult Patients With Ph-negative B-cell Acute Lymphocytic Leukemia: A Prospective, Single-arm Clinical Study","Inclusion Criteria:\n\n1. Newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia according to World Health Organization (WHO) 2016 criteria\n2. CD22 positive tumor cells\n3. ≥18 years of age\n4. Estimated survival ≥3 months\n5. Consent and effective contraception for men and women of childbearing potential\n6. Understanding and signing of informed consent forms and agreement to comply with study requirements.\n\nExclusion Criteria:\n\n1. Burkitt lymphoma\u002Fleukemia\n2. acute leukemias of ambiguous lineage\n3. pregnant women\n4. severe uncontrolled active infection\n5. previous history of chronic liver disease (e.g. cirrhosis) or venous occlusive liver disease (VOD) or sinus obstruction syndrome (SOS)\n6. History of clinically significant ventricular arrhythmia, syncope of unknown origin (not vasovagal) or sinoatrial block or higher degree atrioventricular (AV) block Chronic bradycardia state (unless permanent pacemaker implanted)\n7. New or chronic hepatitis B or C infection (positive for hepatitis B surface antigen and anti-hepatitis C antibody, respectively) or known HIV seropositivity. HIV testing may need to be performed according to local regulations or practices\n8. Psychiatric disorders likely to prevent the subject from completing treatment or informed consent\n9. Other conditions considered unsuitable for the study by the investigator.",{"count":157,"type":21},53,[159],"PHASE2","In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL) among adult patients, therapeutic outcomes remain suboptimal despite advances in chemotherapy and immunotherapy. A subset of adults with Ph- B-ALL have comorbidities or physiological limitations that preclude the safe administration of intensive regimens. In recent years, tumor immunotherapy has demonstrated promising safety and efficacy profiles in refractory or relapsed Ph- B-ALL across a wide spectrum of adult ages. These findings suggest that broader application of immunotherapy may represent a critical strategy to improve survival in this population. In this study, we propose a regimen that combines immuno-targeted agents with low-intensity chemotherapy for newly diagnosed adult patients with Ph- B-ALL. Our primary objective is to increase the rate of measurable residual disease (MRD)-negative complete remission (CR) following induction therapy, reduce the risk of relapse, and ultimately enhance overall survival.",[28],[163,66,164,165,166,167],"Philadelphia Chromosome-Negative","Elderly Or Unfit","Immuno-targeted Drugs","Low-dose Chemotherapy","Single-arm Clinical Study","2025-12-09",{"date":170,"type":40},"2025-12-17",{"date":172,"type":40},"2024-04-02",{"date":44,"type":21},{"name":175,"class":80},"Institute of Hematology & Blood Diseases Hospital, China",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":48},"100570609","phase-1-phase-i-clinical-trial-of-cart-cell-therapy-for-refractoryrelapsed-acute-lymphoblastic-leukemia-in-children-adolescents-and-young-adults-100570609","NCT06709469","Phase I Clinical Trial of CART Cell Therapy for Refractory\u002FRelapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults","A Phase I Clinical Trial of CART Cell Therapy for Refractory\u002F Relapsed Acute Lymphoblastic Leukemia With Unmet Needs in Children, Adolescents and Young Adults: Feasibility and Safety Study (REALL_CART).","REALL_CART","Inclusion Criteria:\n\n* ARM A: CD19+\u002F- CD22+ B-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. Treatment with previous CART CD19 therapy is permitted, but is not mandatory, OR:\n* ARM B: T-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available.\n* Patients diagnosed with ALL must be suitable for allogeneic HSCT and willing to proceed to transplant if the CART treatment induces complete remission and the investigator believes it is the best option.\n* For ARM B there must be a suitable haploidentical donor (following local standard operating procedures).\n* Lansky (age \\\u003C16 years) or Karnofsky (age ≥16 years) score of 50 or greater.\n* Life expectancy greater than 12 weeks.\n* Absolute neutrophil count (ANC) ≥ 500\u002FμL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy.\n* Platelet count ≥ 50,000\u002FμL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy.\n* Absolute lymphocyte count ≥ 100\u002FμL.\n* Adequate renal, hepatic, pulmonary, and cardiac function.\n* Adequate venous access and absence of contraindications for lymphoapheresis\n* Patients with a seizure disorder may be enrolled if well controlled with anticonvulsants.\n* Patients or patients' legal representative, parent(s), or guardian able to provide written informed consent.\n\nExclusion Criteria:\n\n* Enrolled in another clinical trial in the previous 4 weeks.\n* Active infection requiring systemic medical therapy including clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, adenovirus, BK-virus, HHV-6 or Aspergillus.\n* Any of the following cardiac criteria: cardiac echocardiography with LVSF\\\u003C30% or LVEF\\\u003C40%; or clinically significant pericardial effusion.\n* Presence of CNS-3 disease or uncontrolled seizure disorder.\n* Active immunosuppressive therapy with the exception of prednisone 10 mg\u002Fday (or equivalent), within 7 days prior to enrolment.\n* GFR \\\u003C30 ml\u002Fmin or bilirubin \\>3 times the upper limit of normality (unless due to Gilbert's syndrome).\n* Any other condition that, in the opinion of the PI, may interfere with the efficacy and\u002For safety evaluation of the trial.\n* Pregnant or lactating women.\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests. Male partner should use a condom. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant.\n* Sexually active males should use a condom during intercourse for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests.","30 Years",{"count":186,"type":21},10,[24],"The goal of this clinical trial is to test the feasibility and safety of an academic production of two different anti-CD19 chimeric antigen receptor T cells (CART) products according to the different biomarkers of the disease in children and young adults with relapsed\u002Frefractory CD19+ B cell acute lymphoblastic leukemia (r\u002Fr B-ALL) or relapsed\u002Frefractory T-cell acute lymphoblastic leukemia (r\u002Fr T-ALL). The main questions it aims to answer are:\n\n1. The safety and feasibility of autologous CART-19\u002F22 in children, adolescents and young adults with a CD19+\u002F- CD22+ relapse\u002F refractory disease for a r\u002Fr B-ALL.\n2. The safety and feasibility of allogeneic CART-NKG2D (chimeric-antigen receptor Natural-killer group 2, member D) in children, adolescents and young adults with r\u002Fr T-ALL.",[28],"2025-09-19",{"date":192,"type":40},"2025-09-22",{"date":194,"type":40},"2025-07-08",{"date":196,"type":21},"2030-12-01",{"name":198,"class":80},"Instituto de Investigación Hospital Universitario La Paz",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":48},"100490003","phase-2-pediatric-inspired-regimen-combined-with-venetoclax-for-adolescent-and-adult-patients-with-de-novo-philadelphia-chromosome-negative-acute-lymphoblastic-leukemia-100490003","NCT05660473","Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* De novo and primary Ph\u002FBCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification\n* Age: 14 -60 years\n* Male or female\n* ECOG Performance Status 0-2\n* Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%;\n* Subject has provided written informed consent prior to any screening procedure\n\nExclusion Criteria:\n\n* Burkitt lymphoma\u002Fleukemia\n* Acute Leukemia of Ambiguous Lineage\n* Female patients who are pregnant or breast feeding\n* Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment\n* History of pancreatitis\n* Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \\>7.5%. Patients with preexisting, well-controlled diabetes are not excluded\n* History of active gastrointestinal bleeding within the last 6 months\n* History of arterial\u002Fvenous thrombosis within the last 6 months\n* Known HIV seropositivity\n* Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment","14 Years","60 Years",{"count":208,"type":21},100,[159],"The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.",[28],[163,66,213,214,215],"Adolescent and Adult","Pediatric-inspired Regimen","Venetoclax","2025-07-31",{"date":218,"type":40},"2025-08-01",{"date":220,"type":40},"2022-08-01",{"date":222,"type":21},"2027-12-30",{"name":175,"class":80},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":230,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":48},"100506356","glucose-intolerance-and-diabetes-related-to-treatment-with-steroids-and-peg--asparaginase-in-children-and-adolescents-with-all-and-lymphoma-100506356","NCT05873322","Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG- Asparaginase in Children and Adolescents With ALL and Lymphoma","Inclusion Criteria:\n\n* All children and adolescents diagnosed with ALL and Lymphoma and treated according to the established and approved treatment protocols for these diseases in Denmark can be included in the study.\n\nExclusion Criteria:\n\n* Children and adolescents not fulfilling the inclusion criteria.","1 Year","17 Years",{"count":208,"type":21},"OBSERVATIONAL","The overall survival of acute lymphoblastic leukemia (ALL) and lymphoma in children and adolescents is above 90%. The survival rate has increased significantly during the last decades as a consequence of more intensive chemotherapy. This very toxic treatment results in severe acute toxicities and late effects, which is the biggest challenge today besides survival. The overall purpose of contemporary ALL treatment is to reduce the toxic treatment without compromising the excellent survival rates of these diseases. This study is a part of this. The researchers want to investigate the incidence of glucose intolerance and medicine induced diabetes during treatment for ALL and lymphoma with steroids (prednisolone or dexamethasone) and ± PEG-asparaginase.\n\nSteroids and asparaginase are used in the treatment of ALL and lymphomas, and both drugs may induce glucose intolerance or diabetes, especially when they are given concomitantly. The incidence and duration of increased blood glucose levels are not very well investigated, and especially not monitored continuously during treatment phases with steroids and +\u002F- asparaginase, as the investigators want to do in this study.\n\nIn the study the participants must have a glucose sensor attached under the skin, which continuously measures blood glucose during treatment. Moreover, blood samples are drawn several times to measure insulin sensitivity and beta cell function.\n\nThe participants are children and adolescents (1.0-17.9 years) with newly diagnosed ALL or lymphoma treated at one of the four Danish pediatric oncology sites.\n\nBlood glucose levels are followed during treatment with steroids and PEG-asparaginase in these patient groups. The results may give rise to a new treatment guidelines for measuring and treating blood glucose in these patients. In the future this may help reduce the development of type 2 diabetes mellitus and metabolic syndrome in survivors of ALL and lymphoma.",[28,236,237,238],"Drug-Induced Diabetes Mellitus","Impaired Glucose Tolerance","Lymphoma","2024-08-13",{"date":241,"type":40},"2024-08-14",{"date":243,"type":40},"2022-08-30",{"date":245,"type":21},"2025-12-31",{"name":247,"class":80},"Aarhus University Hospital",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":48},"100534312","mrd-associated-non-intensive-but-non-interruptive-treatment-of-ph-negative-acute-lymphoblastic-leukemia-adult-patients-100534312","NCT06237192","MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients","Multicenter Prospective Study of Safety and Efficacy MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients","Inclusion Criteria:\n\n• age 18-55 years old of patient,\n\n\\- Clinical diagnosis of non-treated Ph-negative ALL\n\nExclusion Criteria:\n\n• age more than 55 years old,\n\n* Clinical diagnosis of Ph-positive ALL\n* Clinical diagnosis of relapsed\u002Frefractory ALL,","55 Years",{"count":257,"type":21},200,[61],"Non-intensive But Non-interruptive Treatment based on previously study RALL-2016 of Adult Ph-negative Acute Lymphoblastic Leukemia: No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive consolidation 1-3 with venetoclax (56 days), and B-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive 1 consolidation with blinatumomab. After that consolidation bone samples are collected and tested for MRD and patients will continue therapy by protocol without HSCT if MRD-negative (by flow cytometry by aberrant immunophenotype in a centralized lab) status was achieved.",[28],"2024-01-31",{"date":263,"type":40},"2024-02-01",{"date":265,"type":40},"2023-04-01",{"date":267,"type":21},"2027-09-01",{"name":269,"class":270},"National Research Center for Hematology, Russia","NETWORK","Precursor-cell Lymphoblastic Leukemia-Lymphoma"]