[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-acute-lymphoblastic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-acute-lymphoblastic":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,56,94,116,148,172],{"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":26,"conditions":27,"keywords":35,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100544095","phase-1-anti-cd19-chimeric-antigen-receptor-t-cell-immunotherapy-for-leukemias-100544095",false,"NCT06364423","Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias","Phase I\u002FII Trial of Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for B-cell Leukemias","* INCLUSION CRITERIA:\n* Malignancy criteria\n\n  * Histologically confirmed participants with either CLL or SLL or B-cell acute lymphoblastic leukemia or lymphoma (ALL) via immunohistochemical or flow cytometry methods will be eligible. Participants with evidence of Richter s transformation of CLL\u002FSLL are also eligible. Participants with Richter s transformation must have current or prior evidence of CLL, confirmed by review of a current or prior histological sample by NIH pathologists or confirmed by flow cytometry performed at the NIH.\n  * Demonstration of CD19 expression on CLL\u002FSLL or ALL, as assessed by the NCI Laboratory of Pathology or NIH Department of Laboratory Medicine Hematopathology section. For participants with pathologically confirmed Richter s transformation, the transformed cells must also have CD19 expression.\n  * CD19 expression must be uniform meaning no populations of clearly CD19-negative CLL\u002FSLL, Richter s or ALL cells are observed.\n  * CD20 must be detected on \\>= 20% of malignant cells by flow cytometry or immunohistochemistry. Documentation of CD20 expression is not required for patients who have received CD20-directed therapy within 90 days prior to the date of enrollment.\n  * The last dosage of systemic therapy (including corticosteroids) must be at least 14 days prior to the first dose of rituximab, with the exceptions of BTK inhibitors (BTKi) for CLL\u002FSLL and tyrosine kinase inhibitors (TKI) for ALL. Participants who were receiving a BTKi for CLL\u002FSLL or a TKI for ALL for at least 14 days prior to protocol enrollment can continue these agents during part of the time the participants are enrolled on this clinical trial.\n  * For participants who have received antibodies targeting CD19, at least sixty days must elapse between therapy with antibodies targeting CD19 and CAR T-cell infusion.\n  * Participants with CLL\u002FSLL must have received at least two prior treatment regimens, at least one of which must have contained a Bruton s tyrosine kinase (BTK) inhibitor. Participants who took a BTK inhibitor but stopped due to intolerance are potentially eligible. Participants with relapsed or refractory CLL\u002FSLL after alloHSCT are eligible.\n  * Participants with refractory ALL that failed induction or participants with relapsed ALL after a standard induction regimen or after any later line of therapy are eligibleParticipants with relapsed or refractory ALL after alloHSCT are eligible.\n  * All participants must have measurable malignancy as defined by at least one of the criteria below.\n\n    * Presence of CLL,SLL, or ALL masses that are measurable (minimum 1.5 cm in largest diameter) by CT scan or PET\u002FCT is required unless bone marrow or blood involvement with malignancy is detected.\n    * For CLL\u002FSLL or ALL with only bone marrow and\u002For blood involvement, no mass is necessary, but if a mass is not present, bone marrow and\u002For blood malignancy must be detectable by flow cytometry. Any level of CLL\u002FSLL or ALL detectable by flow cytometry is sufficient.\n* Other inclusion criteria:\n\n  * Age \\>= 18 years.\n  * Performance status (ECOG) 0-1.\n  * Participants must have adequate organ and marrow function as defined below:\n\n    * ANC \\>= 1,000\u002FmcL without the support of filgrastim or other growth factors in the 10 days prior to screening assessment\n    * platelets \\>= 50,000\u002FmcL without transfusion support\n    * hemoglobin \\>= 8 g\u002FdL\n    * total bilirubin \\\u003C= 2.0 mg\u002FdL\n    * ALT or AST Serum ALT and AST less or equal to 3 times the upper limit of the institutional normal unless liver involvement by malignancy is demonstrated. If liver involvement with malignancy is detected, ALT and AST must be less than or equal to 5 times the upper limit of normal\n    * Serum Creatinine Serum creatinine levels \\\u003C 1.5 X institutional ULN. Participants with serum creatinine \\>= 1.5 X institutional ULN may participate if serum creatinine eGFR is \\>=50 mL\u002Fmin\u002F1.73m\\^2 by 2021 CKD-EPI equation.\n\n      * ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase);\n      * AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n      * (A)Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n  * For CLL participants, B cells must make up less than 95% of blood lymphocytes on a lymphocyte phenotyping profile TBNK at the time of screening assessment. For ALL participants, the peripheral blood blast percentage on CBC differential must be 1% or less.\n  * Room air oxygen saturation of 92% or greater\n  * Participants of child-bearing or child-fathering potential must be willing to practice abstinence or highly effective contraception starting at the time of study entry, for the duration of study therapy, and for 12 months after receiving the protocol treatment.\n  * Participants must agree not to donate eggs for 12 months after receiving the protocol treatment\n  * Participants who are breastfeeding must be willing to cease breastfeeding from study treatment initiation through 12 months after the last dose of the study drugs.\n  * Participants must have a negative blood PCR test for hepatitis B DNA. If hepatitis B DNA (PCR) testing is not available, participants must have a negative hepatitis B surface antigen and negative hepatitis B core antibody test.\n  * Participants must have a negative blood PCR test for hepatitis C RNA. Only if Hepatitis C PCR testing is not available in a timely manner, participants must have a negative Hepatitis C antibody test.\n  * Cardiac ejection fraction of greater than or equal to 50% by echocardiography and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram within 30 days prior to treatment start.\n  * All participants must have the ability to understand and willingness to sign a written informed consent.\n  * All participants must be willing to undergo mandatory biopsies during the study.\n\nEXCLUSION CRITERIA:\n\n* Participants who are receiving any other investigational agents.\n* Participants who have had prior CAR T-cell therapy.\n* Participants who have had a live-attenuated or viral vector-based vaccine in the last 60 days prior to pre-leukapheresis rituximab. Participants who plan to receive a live attenuated or viral vector-based vaccine within the first 100 days after CAR T-cell infusion.\n* Participants that require urgent therapy due to tumor mass effects or spinal cord compression.\n* Current\u002Factive HIV infection, as measured by seropositivity for HIV antibody.\n* Participants with second malignancies in addition to their CLL or ALL are not eligible if the second malignancy has required treatment with surgery, radiation or chemotherapy, or other therapies within the past 2 years or is not in complete remission. Exceptions are that, in the last 2 years, participants may have had successful resection of non-metastatic basal cell or squamous cell carcinoma of the skin, and participants may have received hormonal therapy for fully resected breast cancer.\n* Positive beta Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in women of childbearing potential (WOCBP) performed at screening.\n* Active uncontrolled systemic infections (defined as infections causing fevers within 48 hours of the date of planned protocol rituximab or chemotherapy start and infections requiring intravenous antibiotics when intravenous antibiotics have been administered for less than 72 hours at the time of protocol rituximab or chemotherapy start). There must be objective evidence of infection, including, but not limited to, a positive blood, urine or sputum culture, positive nasal swab or blood test for viral infection, or the appearance of infiltrates on imaging of the lung.\n* Active coagulation disorders, major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, history of myocardial infarction, history of ventricular tachycardia or ventricular fibrillation, active cardiac arrhythmias with the exception of atrial fibrillation with baseline heart rates less than or equal to 90 beats per minute, (Use of medications to control heart rate is allowed.), active obstructive or restrictive pulmonary disease, or active autoimmune diseases such as rheumatoid arthritis. These include uncontrolled intercurrent illness manifesting as electrolyte derangements or as assessed by chemistries.\n* Significant neurologic disorders, including a history of a seizure disorder as an adult, that are not completely and permanently resolved and not requiring current treatment.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) that has not been cured by a prior allogeneic stem cell transplant.\n* For participants that have not had prior allogeneic stem cell transplant: Systemic corticosteroid steroid therapy of any dose greater than 5 mg\u002Fday or more of prednisone or equivalent is not allowed within 14 days prior to the first dose of rituximab. Corticosteroid creams, ointments, and eye drops are allowed.\n* For participants that have had prior allogeneic stem cell transplant: Receiving any systemic immunosuppressive drugs including corticosteroids at doses of greater than 5 mg\u002Fday prednisone or equivalent within 28 days prior to Rituximab. Topical corticosteroid preparations applied to the skin such as solutions, creams, and ointments are allowed. Inhaled corticosteroids are allowed, and corticosteroid eye drops are allowed.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study, including hypersensitivity to aminoglycoside antibiotics, which may be used in the cell culture media.\n* Participants with CNS3 disease, neurologic signs of CNS disease, radiologically detected active CNS lymphoma or meningeal involvement.\n* Checkpoint inhibitor drugs such as pembrolizumab or nivolumab or other antibodies targeting PD-1 or PDL-1 within 180 days of pre-leukapheresis rituximab. This is because of possible effects checkpoint inhibitor therapy could have on the participant's T cells.\n* Known active alcohol or drug abuse.\n* History of allergy to study drug components.\n* Active tumor lysis syndrome as assessed by serum uric acid, LDH, calcium, and phosphorus.\n* Active rhabdomyolysis as assessed by elevated CK and acute change in renal function as reflected by increased creatinine and blood urea nitrogen (BUN).\n* Active diabetic ketoacidosis or hyperosmolar hyperglycemic state, as assessed by serum glucose. The urine will be tested for ketones if serum glucose is over 350 mg\u002FdL at screening.\n* Participants who received a previous allogeneic HSCT must have no (grade 0) acute GVHD (Appendix H) and either no chronic GVHD or mild chronic GVHD. Participants with GVHD meeting the above criteria with local therapy (topical cutaneous steroids, inhaled steroids, and eye drops) will be eligible for enrollment.","ALL","18 Years","120 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nChronic lymphocytic leukemia (CLL),small lymphocytic lymphoma (SLL) and B-cell acute lymphoblastic leukemia or lymphoma (ALL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. CD19 is a protein often found on the surfaces of these cancer cells. Researchers can modify a person's own immune cells (T cells) to target CD19. When these modified T cells are returned to the body-a treatment called anti-CD19 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.\n\nObjective:\n\nTo test anti-CD19 CAR T cell therapy in people with CLL or SLL and ALL.\n\nEligibility:\n\nPeople aged 18 years and older with CLL or SLL and ALL that has not been controlled with standard drugs.\n\nDesign:\n\nParticipants will be screened. They will have imaging scans and tests of their heart function. If a sample of tissue from their tumor is not available, a new one may be taken; the sample will be tested for CD19.\n\nParticipants will receive a drug to reduce the leukemia cells in their blood. Then they will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be gene edited to make them attack cells with CD19.\n\nParticipants will take drugs to prepare them for treatment for 3 days. These drugs will start 5 days before the treatment. Then their own modified CAR T cells will be returned to their bloodstream. Participants will stay in the hospital for at least 9 days after the treatment.\n\nFollow-up visits will continue for 5 years.",[28,29,30,31,32,33,34],"Leukemia, Lymphocytic, Chronic, B-Cell","B-Lymphocytic Leukemia, Chronic","B-Cell Chronic Lymphocytic Leukemia","Acute Lymphoblastic Leukemia","Lymphoblastic Lymphoma","Leukemia, Acute Lymphoblastic","Small Lymphocytic Lymphoma",[34,36,37,38,39,40,41,42,16,31],"Immunotherapy","CLL","Chronic Lymphocytic Leukemia","Chimeric Antigen Receptors","Autologous T Cells Infusion","Adoptive T Cell Therapy","CAR","RECRUITING","2026-06-23",{"date":46,"type":47},"2026-06-24","ACTUAL",{"date":49,"type":47},"2024-09-03",{"date":51,"type":21},"2030-07-01",{"name":53,"class":54},"National Cancer Institute (NCI)","NIH",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100386119","phase-3-a-treatment-study-protocol-for-participants-0-45-years-with-acute-lymphoblastic-leukaemia-100386119","NCT04307576","A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia","ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL)","Inclusion Criteria:\n\n* Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopoetic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* Age 0 - \\\u003C 46 years (one day before 46th birthday) at the time of diagnosis with the exception of infants with KMT2A-rearranged (KMT2A-r) BCP ALL.\n* Patients with surface immunoglobulin negative (sIG-) BCP-ALL and an IG::MYC rearrangement, unless they have a concurrent BCL2\u002F6 rearrangement. T-ALL patients with MYC translocations.\n* Informed consent signed by the patient and\u002For parents\u002Flegal guardians according to country-specific age-related guidelines.\n* The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.\n* The patient should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Patients who are visiting the country as tourists should not be included. However, returning expatriots with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.\n* All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.\n* For each intervention\u002Frandomisation an additional set of inclusion-criteria is provided.\n\nExclusion Criteria:\n\n* Age \\\u003C 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and\u002For a KMT2A fusion transcript).\n* Age \\>45 years at diagnosis.\n* Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).\n* Relapse of ALL.\n* Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2\u002F6 rearrangement.\n* Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and\u002For of the BCR::ABL fusion transcript). These patients will be transferred to an appropriate trial for t(9;22) if available.\n* Previously known ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory and patients in whom genetic work-up reveals a new germ-line mutation (index-cases) will remain in the study.\n* Treatment with systemic corticosteroids corresponding to (\\>10mg prednisolone\u002Fm2\u002Fday) for more than one week and\u002For other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).\n* Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment).\n* Any other disease or condition, as determined by the investigator, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.\n* Women of childbearing potential who are pregnant at the time of diagnosis.\n* Women of childbearing potential and fertile men who are sexually active and are unwilling to use adequate contraception during therapy. Efficient birth control is required.\n* Female patients, who are breast-feeding.\n* Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).\n* For each intervention\u002Frandomisation an additional set of exclusion-criteria is provided.","0 Years","45 Years",{"count":66,"type":21},6430,[68],"PHASE3","ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.",[33],[72,73,16,74,75,76,77,78,79,80,81,82],"Leukemia","Acute Leukemia","ALLTogether","Leukaemia","Inotuzumab ozogamicin","Besponsa","ALLTogether1","Blinatumomab","Blincyto","6-tioguanine","6-thioguanine","2026-04-29",{"date":85,"type":47},"2026-05-05",{"date":87,"type":47},"2020-07-13",{"date":89,"type":21},"2033-06",{"name":91,"class":92},"Mats Heyman","OTHER",138,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":64,"enrollmentInfo":101,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":114,"locationsCount":115},"100355680","a-treatment-protocol-for-participants-0-45-years-with-acute-lymphoblastic-leukaemia-100355680","NCT03911128","A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia","A Treatment Study Protocol of the ALLTogether Consortium for Infants, Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL): a Pilot Study","Inclusion Criteria:\n\n* Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* Age 0 - \\\u003C 46 years (one day before 46th birthday) at the time of diagnosis, with the exception of infants with KMT2A-r BCP ALL (see exclusion criteria below).\n* Patients with surface immunoglobulin negative (sIG-) BCP-ALL and an IG::MYC rearrangement, unless they have a concurrent BCL2\u002F6 rearrangement. T-ALL patients with MYC translocations.\n* Informed consent signed by the patient and\u002For parents\u002Flegal guardians according to country-specific age related guidelines\n* The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.\n* The patient should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Patients who are visiting the country as tourists should not be included. However, returning expatriots and patients who intend to stay at least for the duration of the treatment with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.\n* All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.\n\nExclusion Criteria:\n\n* Age \\\u003C 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and\u002For a KMT2A fusion transcript). These patients will be transferred to an appropriate trial for infant KMT2A-r BCP-ALL, if available.\n* Age \\>45 years at diagnosis.\n* Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).\n* Relapse of ALL.\n* Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2\u002F6 rearrangement.\n* Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and\u002For of the BCR::ABL1 fusion transcript). These patients will be transferred to an appropriate trial for t(9;22) if available.\n* Previously known ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory and patients in whom genetic work-up reveals a new germ-line mutation (index-cases) will remain in the study.\n* Treatment with systemic corticosteroids corresponding to (\\>10mg prednisolone\u002Fm2\u002Fday) for more than one week and\u002For other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).\n* Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment).\n* Any other disease or condition, as determined by the investigator, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.\n* Women of childbearing potential who are pregnant at the time of diagnosis.\n* Women of childbearing potential and fertile men who are sexually active and are unwilling to use adequate contraception during therapy. Efficient birth control is required, see section 18.9.\n* Female patients, who are breast-feeding.\n* Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).",{"count":102,"type":21},500,"OBSERVATIONAL","The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design.\n\nThe pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries\u002Fstudy-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study.\n\nThe study only includes \"standard of care\" treatment included in the master protocol.",[33],[72,107,16,74,75],"Acute Lymphoblastic","2025-08-25",{"date":110,"type":47},"2025-09-02",{"date":112,"type":47},"2019-08-29",{"date":89,"type":21},{"name":91,"class":92},53,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100523874","phase-1-cd19-directed-car-t-cell-therapy-for-rr-acute-leukemia-and-lymphoma-100523874","NCT06101381","CD19-directed CAR-T Cell Therapy for R\u002FR Acute Leukemia and Lymphoma","CD19-directed CAR-T Cell Therapy for Refractory or Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma: a Multicenter Phase I\u002FII Trial.","CARTHEDRALL","Inclusion Criteria:\n\nFor non-Hodgkin Lymphomas (B-NHL):\n\n* Provision of signed Informed Consent form;\n* Age between 18 and 70 years;\n* Performance status according to the Eastern Cooperative Oncology Group \\\u003C 2;\n* Relapsed or refractory B-NHL of the following types (confirmed by biopsy):\n\n  * Diffuse large B-cell lymphoma (DLBCL, NOS);\n  * High-grade B-cell lymphoma (HGBCL);\n  * Diffuse large B-cell lymphoma\u002Fhigh-grade B-cell lymphoma with MYC and BCL-2 rearrangement;\n  * Follicular lymphoma (FL) grade 3B; or\n  * Transformed follicular lymphoma (tFL)\n* Refractory or relapsed to two or more lines of systemic therapy, with at least one scheme containing an anti-CD20 monoclonal antibody and anthracycline, as defined below:\n\n  * Refractoriness: partial response (PR), stable disease (SD), or progressive disease (PD) as the best response to the last treatment, assessed by PET-CT, according to the Lugano criteria and confirmed by a new biopsy.\n  * Relapsed disease: disease reappearance after obtaining a complete response to the last treatment, assessed by PET-CT, according to the Lugano criteria and confirmed by a new biopsy.\n* Have performed, or be ineligible for, autologous hematopoietic progenitor cell transplantation (ASCT). Ineligibility is defined by:\n\n  * Lack of at least partial response after salvage chemotherapy; or\n  * Failure to mobilize and\u002For collect hematopoietic progenitor cells (HPC), as defined by the investigator.\n* Measurable disease, defined as:\n\n  * Nodal lesions \\>15 mm in the long axis, regardless of the length of the short axis, and\u002For\n  * Extranodal lesions (outside lymph node or nodal mass, but including liver and spleen) \\>10 mm in long axis, regardless of the length of the short axis.\n* Adequate organ function:\n\nRenal function defined as:\n\n* estimated glomerular filtration rate (eGFR) ≥ 40 mL\u002Fmin\u002F1.73 m2\n\nHepatic function defined as:\n\n* Alanine Transaminase (ALT) and Aspartate Transaminase (AST) ≤ 2.5 × ULN; and\n* Total bilirubin ≤ 1.5 × ULN, except for patients with Gilbert syndrome.\n\nHematologic Function (regardless of transfusions for 14 days) defined as:\n\n* Absolute neutrophil count (ANC) \\>500\u002FuL\n* Platelets ≥ 50,000\u002FuL\n* Hemoglobin \\>7.0 g\u002Fdl\n\n  * In women of childbearing potential, willingness to use effective means of birth control for 1 year after CAR-T cell infusion.\n  * In male participants, willingness to use a barrier birth control method for 1 year after CAR-T cell infusion\n  * Able to comply with inpatient treatment, outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.\n\nFor Acute Lymphoblastic Leukemia (B-ALL):\n\n* Provision of signed Informed Consent form;\n* Age ≥ 3 and \\\u003C 25 years;\n* Performance status \\\u003C 2, according to the Eastern Cooperative Oncology Group for patients ≥ 16 years old, or ≥ 50%, according to the Lansky performance status for patients younger than 16 years old;\n* Relapsed or refractory CD19 positive B-ALL, with documentation of CD19 disease expression within 3 months of screening visit.\n* Relapsed or refractory disease as defined below;\n\n  * Failure to obtain hematologic complete remission (bone marrow with \\\u003C 5% lymphoblasts by morphologic assessment) after 2 distinct chemotherapy lines; or\n  * Relapsed or refractoriness after at least 1 previous chemotherapy regimen and ineligibility for allogeneic hematopoietic progenitor cell transplantation (HSCT) due to lack of available donor (including alternative donors), comorbidity, have previously undergone or refused HSCT; or\n  * Relapsed disease ≥ 6 months after HSCT; or\n  * Relapsed or refractoriness after ≥ TKi for Philadelphia-positive B-ALL.\n* Bone marrow with ≥ 5% lymphoblasts by morphologic assessment within 30 days from screening\n* Adequate organ function:\n\nRenal function defined as:\n\n* Estimated glomerular filtration rate (eGFR) ≥ 40 mL\u002Fmin\u002F1.73 m2\n\nHepatic function defined as:\n\n* Alanine Transaminase (ALT) and Aspartate Transaminase (AST) ≤ 5 × ULN; and\n* Total bilirubin ≤ 2 × ULN, except for patients with Gilbert syndrome.\n\n  * In women of childbearing potential, willingness to use effective means of birth control for 1 year after CAR-T cell infusion.\n  * In male participants, willingness to use a barrier birth control method for 1 year after CAR-T cell infusion\n  * Able to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation. duration of the parent study and the long-term follow-up observational study\n\nExclusion Criteria:\n\nFor non-Hodgkin Lymphomas (B-NHL):\n\n* Previous or concurrent cancer distinct from B-NHL within 2 years before screening, except for the following:\n\n  * Curatively treated nonmelanomatous skin cancer;\n  * Curatively treated cervical carcinoma in situ;\n  * Localized breast cancer treated with curative intent with no evidence of active disease; or\n  * Localized prostate cancer undergoing active surveillance or anti-androgenic therapy, without evidence of metastatic disease.\n* Syndromes and\u002For genetic diseases with impact on the hematopoietic system, including Down's syndrome, Fanconi anemia, telomeropathies, Li Fraumeni, Blackfan-Diamond anemia, or congenital immunodeficiencies;\n* History of previous CAR-T therapy;\n* History of previous solid organ transplantation;\n* Active central nervous system (CNS) involvement by disease, detected by image or cytology\u002Fimmunophenotyping of cerebrospinal fluid (CSF);\n* Primary central nervous system lymphoma (PCNSL);\n* Primary mediastinal large B cell lymphoma (PMBCL);\n* Evidence of uncontrolled systemic infection (viral, bacterial, or fungal) which requires IV antibiotics, within 2 weeks before the screening visit;\n* Known HIV infection;\n* Known HTLV I and II infection;\n* History of previous tuberculosis;\n* Positive Chagas disease serology;\n* Hepatitis B or hepatitis C testing indicating active\u002Fongoing infection, as defined as:\n\n  * HBV: Patients with positive HBsAg are excluded. Patients with positive anti-HBc and negative HBsAg require hepatitis B PCR evaluation before randomization. Patients who are hepatitis B PCR-positive will be excluded.\n  * HCV: Patients with positive hepatitis C antibody may be enrolled with a negative result for hepatitis C RNA before study inclusion. Patients who are hepatitis C RNA-positive will be excluded.\n* History of a symptomatic CNS disease (or which required treatment within the past year), such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease;\n* Significant cardiovascular disease defined as ≥ grade 3 New York Heart Association functional classification system of heart failure, history of myocardial infarction, uncontrolled or symptomatic arrhythmias, or unstable angina within the past 6 months before the screening;\n* Chronic lung disease, with hypoxemia (Oxygen saturation measured by pulse oximetry \\> 93% on room air), or uncontrolled within 4 weeks before the screening visit\n* History of an autoimmune disease (including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis) with end-organ damage or requiring systemic immunosuppression\u002Fsystemic disease-modifying agents in the 2 years preceding the screening visit;\n\n  * Participants with hypothyroidism receiving a stable dose of thyroid replacement hormone may be eligible.\n  * Participants with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* History of deep vein thrombosis or pulmonary embolism within 6 months before the screening visit, or need to use systemic anticoagulation at the time of screening for any other reason;\n* Major surgery within 4 weeks of the screening visit;\n* History or suspicion of hemophagocytic lymphohistiocytosis (HLH);\n* Vaccination with a live or attenuated virus vaccine within one month before the screening visit;\n* Patients with known hypersensitivity, including anaphylaxis, to any component of the investigational treatment;\n* Pregnancy, lactation, or plan to get pregnant during the study or within 12 months after CAR-T cell infusion;\n* In women of childbearing potential a negative serologic pregnancy test must be obtained 7 days before CAR-T cell infusion;\n* Women of childbearing potential, and all male participants, must be willing to observe barrier and highly effective birth control methods (outlined in the study protocol) for 12 months following CAR-T cell infusion;\n* Presence of any other medical condition that in the investigator's opinion may interfere with the safety or effectiveness evaluation of the study;\n* Life expectancy less than 12 weeks, by investigator assessment.\n\nFor Acute Lymphoblastic Leukemia (B-ALL)::\n\n* Previous or concurrent cancer distinct from B-NHL within 2 years before screening, except for the following:\n\n  * Curatively treated nonmelanomatous skin cancer;\n  * Curatively treated cervical carcinoma in situ;\n  * Localized breast cancer treated with curative intent with no evidence of active disease; or\n  * Localized prostate cancer undergoing active surveillance or anti-androgenic therapy, without evidence of metastatic disease.\n* Syndromes and\u002For genetic diseases with impact on the hematopoietic system, including Down's syndrome, Fanconi anemia, telomeropathies, Li Fraumeni, Blackfan-Diamond anemia, or congenital immunodeficiencies;\n* Isolated extramedullary disease;\n* Active central nervous system (CNS) involvement by disease (CNS-3 according to NCCN guideline), detected by cytology\u002Fimmunophenotyping of cerebrospinal fluid (CSF) within 30 days from screening visit.\n\n  * Patients with CNS-1 and CNS-2 within 30 days from screening visit may be enrolled;\n* Burkitt's Leukemia\u002FLymphoma\n* Active acute or chronic graft-versus-host disease (GvHD), or controlled with immunosuppressants in the previous 12 weeks before the screening visit;\n* Failure to obtain hematologic complete remission (bone marrow with \\\u003C 5% lymphoblasts by morphologic assessment) after an anti-CD19 antibody-containing treatment (e.g. Blinatumomab);\n* History of previous CAR-T therapy;\n* History of previous solid organ transplantation;\n* Evidence of uncontrolled systemic infection (viral, bacterial, or fungal) which requires IV antibiotics, within 2 weeks before the screening visit;\n* Known HIV infection;\n* Known HTLV I and II infection;\n* History of previous tuberculosis;\n* Positive Chagas' disease serology;\n* Hepatitis B or hepatitis C testing indicating active\u002Fongoing infection, as defined as:\n\n  * HBV: Patients with positive HBsAg are excluded. Patients with positive anti-HBc and negative HBsAg require hepatitis B PCR evaluation before randomization. Patients who are hepatitis B PCR-positive will be excluded.\n  * HCV: Patients with positive hepatitis C antibody may be enrolled with a negative result for hepatitis C RNA before study inclusion. Patients who are hepatitis C RNA-positive will be excluded.\n* History of a symptomatic CNS disease (or which required treatment within the past year), such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease;\n* Significant cardiovascular disease defined as ≥ grade 3 New York Heart Association functional classification system of heart failure, history of myocardial infarction, uncontrolled or symptomatic arrhythmias, or unstable angina within the past 6 months before the screening;\n* Chronic lung disease, with hypoxemia (Oxygen saturation measured by pulse oximetry \\> 93% on room air), or uncontrolled within 4 weeks before the screening visit\n* History of an autoimmune disease (including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis) with end-organ damage or requiring systemic immunosuppression\u002Fsystemic disease-modifying agents in the 2 years preceding the screening visit;\n\n  * Participants with hypothyroidism receiving a stable dose of thyroid replacement hormone may be eligible.\n  * Participants with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* History of deep vein thrombosis or pulmonary embolism within 6 months before the screening visit, or need to use systemic anticoagulation at the time of screening for any other reason;\n* Major surgery within 4 weeks of the screening visit;\n* History or suspicion of hemophagocytic lymphohistiocytosis (HLH);\n* Vaccination with a live or attenuated virus vaccine within one month before the screening visit;\n* Patients with known hypersensitivity, including anaphylaxis, to any component of the investigational treatment;\n* Pregnancy, lactation, or plan to get pregnant during the study or within 12 months after CAR-T cell infusion;\n* In women of childbearing potential a negative serologic pregnancy test must be obtained 7 days before CAR-T cell infusion;\n* Women of childbearing potential, and all male participants, must be willing to observe barrier and highly effective birth control methods (outlined in the study protocol) for 12 months following CAR-T cell infusion;\n* Presence of any other medical condition that in the investigator's opinion may interfere with the safety or effectiveness evaluation of the study;\n* Life expectancy less than 12 weeks, by investigator assessment.","3 Years","70 Years",{"count":127,"type":21},81,[24,25],"The goal of this prospective, multicentric, single-arm, phase I\u002FII clinical trial is to evaluate the safety and efficacy of a novel CD19-directed CAR-T cell locally produced in an academic institution in Brazil in patients with refractory or relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma.\n\nParticipants will receive a single intravenous infusion of an autologous academic anti-CD19 CAR-T cell and will be followed for 5 years.",[33,131],"Lymphoma, Non-Hodgkin",[133,134,135,136,137,73],"Cell therapy","Chimeric antigen receptor T cell","CAR-T cell","CD19","Lymphoma","2024-12-04",{"date":140,"type":47},"2024-12-09",{"date":142,"type":47},"2024-03-21",{"date":144,"type":21},"2028-12",{"name":146,"class":92},"University of Sao Paulo",5,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100564262","integrative-omics-approaches-for-leukemia-target-identification-and-matched-therapeutic-intervention-100564262","NCT06626893","Integrative \"Omics\" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention","AL-TOMICA","Inclusion Criteria:\n\n* Patients to be enrolled in the study must have a diagnosis of AML, B ALL\u002FLBL, T ALL\u002FLBL, MPAL\u002FAUL as described by WHO 2016 classification and must complained relapsed or refractory disease after at least one line of therapy\n* Ages Eligible for Study: over 18years\n* Patients must have greater than 5% blasts in the bone marrow with or without extramedullary disease\n* Patients with must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis\n* Patients may be enrolled on study regardless of the timing of prior I therapy\n* Patients must be capable of understanding the investigational nature and the objectives of the study. All patients must sign a written informed consent.\n\nExclusion Criteria:\n\n\\-",{"count":156,"type":21},100,[158],"NA","The goal of this clinical trial is to use multiple \"omics\" sciences to more thoroughly investigate Acute Recurrent\u002FRefractory Leukemias (LA R\u002FR) after conventional therapy in order to identify new targets and\u002For therapeutic approaches, in patients with a diagnosis of Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia\u002F Lymphoblastic Lymphoma B(ALL-B), Acute Lymphoblastic Leukemia\u002FLymphoblastic Lymphoma T (ALL-T), Acute Biphenotypic Leukemia\u002FII as defined by WHO( World Health Organization) 2016, relapsed or refractory after at least one line of therapy. The main question that the trial aims to answer is: \"Can molecules with known biological activity be active and represent possible new therapeutic strategies in relapsed\u002Frefractory Acute Leukemias on the basis of response profiles identified through the integration of next-generation chemogenomic and functional analyses? \" It is expected that a minimum of 100 patients, male and female, aged 18 years and older, will be included. To participate in the study, the patient must consent to the performance on biological specimen (peripheral blood and bone marrow) of genetic\u002Fmolecular and\u002For \"omics\" investigations performed with modern sequencing techniques, such as Next Generation Sequencing, Single Cell RNA Seq (scRNAseq), RT-qPCR(Quantitative reverse transcription polymerase chain reaction). These investigations will aim to improve the understanding of the genetic and molecular alterations of her disease. In addition, your cells will be used in the laboratory to perform in vitro sensitivity studies (drug response profiling - DRP) that aim to simultaneously test a set of hundreds of drugs to assess sensitivity or resistance profiles of your disease cells with the aim of identifying specific new therapies that target specific cellular mechanisms. In addition, part of the biological sample will be used for investigations of the bone marrow microenvironment and the \"secretome\", i.e., cell signaling molecules and methods. In order to accomplish this study, samples from peripheral or bone marrow blood taken during routine investigations performed during follow-up and re-evaluation visits for the patient's disease as per normal clinical practice will be used. Among the investigations that will be performed on the blood sample will be the genetic\u002Fmolecular and\u002For omics and preclinical investigations described above.",[161,33],"Myeloid Leukemia, Acute","2024-10-02",{"date":164,"type":47},"2024-10-04",{"date":166,"type":47},"2022-03-01",{"date":168,"type":21},"2025-03-01",{"name":170,"class":92},"Azienda Ospedaliero-Universitaria di Parma",8,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":179,"maxAge":64,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100378568","effect-of-fish-oil-on-hyperlipidemia-and-toxicities-in-children-and-young-adults-with-acute-lymphoblastic-leukemia-100378568","NCT04209244","Effect of Fish Oil on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia","Effect of Fish Oil Versus Placebo on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Children (1-17.9 years) and young adults (18-45 years) diagnosed with ALL, stratified to very-low risk (VRL), intermediate risk low (IR-low) and intermediate risk high (IR-high) in the ALLTogether protocol.\n\nExclusion Criteria:\n\n* Patients diagnosed with ALL, stratified to high risk (HR) after induction treatment or stem cell transplantation in the ALLTogether protocol","1 Year",{"count":156,"type":21},[158],"Acute lymphoblastic leukemia (ALL) is the most common malignant disease among children. Treatment results have improved over time due to intensive risk-adapted therapy and the 5-year survival rate is now above 90%. However, the burden of therapy has increased proportionally. Many children develop serious acute and chronic side effects, which impact on the patients expected lifespan and impair their quality of life as a result of therapy. Treatment with PEG-asparaginase and dexamethasone increases the levels of triglycerides and total cholesterol. Consequently, the incidence of hyperlipidemia is high during initial ALL therapy. Studies have suggested that hyperlipidemia is a risk factor for development of osteonecrosis, thrombosis and possibly acute pancreatitis.\n\nLong-chained marine omega-3 fatty acids, found in fish oil, decrease levels of triglycerides and total cholesterol in hyperlipidemic patients. Due to the high survival rate, it is of great interest to develop methods to reduce treatment related toxicities.\n\nThe investigators hypothesise that daily intake of fish oil will prevent development of hyperlipidemia during ALL treatment phases with dexamethasone and PEG-asparaginase compared to placebo and that fish oil intake may reduce the incidence of severe adverse events related to ALL treatment.",[33],"2019-12-23",{"date":186,"type":47},"2019-12-26",{"date":188,"type":47},"2019-12-16",{"date":190,"type":21},"2029-12-31",{"name":192,"class":92},"Rigshospitalet, Denmark",4]