[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemia-with-failed-remission\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemia-with-failed-remission":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,92,122,152],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100621498","mb-cart191-in-relapsedrefractory-acute-lymphoblastic-leukemia-100621498",false,"NCT07371403","MB-CART19.1 in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia","MB-CART19.1 in Patients With Relapsed\u002FRefractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study","Inclusion Criteria:\n\n* Age ≥ 1 year as long as if deemed fit by treating investigator\n* CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry.\n* Patients with relapsed or refractory disease with \\>5% blasts in the bone marrow after at least one frontline and one salvage chemotherapy regimen. For patients with Philadelphia-positive disease, a second generation or higher TKI must have been utilized in one of the treatment lines.\n* Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.\n* Estimated life expectancy \\> 12 weeks\n* Karnofsky or Lansky (age dependent) performance score ≥ 60\n* Patients and\u002For parents must give their written informed consent\u002Fassent.\n* CNS and\u002For testicular involvement are allowed, only if cleared and in the presence of systemic involvement.\n\nExclusion Criteria:\n\n* Rapidly progressive, uncontrolled disease as assessed by the treating physician and\u002For principal investigator.\n* Persistent extramedullary disease.\n* Isolated CNS and\u002For testicular disease.\n* Current autoimmune disease, or history of autoimmune disease with potential CNS involvement\n* Active hepatitis B, C or HIV\n* Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)\n* History of an additional malignancy (≤ 3 years) other than non-melanoma skin cancer or carcinoma in situ.\n* Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC \\\u003C 65%) or an oxygen requirement of \\>28% O2 FiO2 or active pulmonary infection.\n* Cardiac function: Left ventricular ejection fraction \\\u003C50% by echocardiography\n* Renal function: Creatinine clearance \\\u003C50 mL\u002Fmin\u002F1.73 m2\n* Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT \\> 5 times upper limit of normal, unless due to leukemic liver infiltration as determined by the investigators.\n* Pregnant or breast-feeding females\n* Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing (\\\u003C0.5 mg\u002Fkg\u002Fday of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, Fludarabine\u002Fclofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, blinatumomab) or investigational drugs or donor lymphocyte","ALL","1 Year",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"NA","Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.",[26,27,28,29,30],"Acute Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia Recurrent","Acute Lymphoblastic Leukemia Refractory","Acute Lymphoblastic Leukemia Not Having Achieved Remission","Acute Lymphoblastic Leukemia With Failed Remission",[32,33,16,34,35,36],"CAR-T","MB-CART19.1","acute lymphoblastic leukemia","relapsed acute lymphoblastic leukemia","refractory acute lymphoblastic leukemia","RECRUITING","2026-03-24",{"date":40,"type":41},"2026-03-25","ACTUAL",{"date":43,"type":20},"2026-02",{"date":45,"type":20},"2029-01",{"name":47,"class":48},"King Hussein Cancer Center","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":74,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":5},"100461746","phase-1-venetoclax-basket-trial-for-high-risk-hematologic-malignancies-100461746","NCT05292664","Venetoclax Basket Trial for High Risk Hematologic Malignancies","A Phase I Study of Venetoclax in Combination With Cytotoxic Chemotherapy, Including Calaspargase Pegol, for Children, Adolescents and Young Adults With High-Risk Hematologic Malignancies","Inclusion Criteria\n\nCohort A Inclusion Criteria:\n\n* MDS, AML arising from MDS (MDS\u002FAML), therapy related myeloid neoplasm (tMDS\u002FAML) meeting at least one of the following criteria:\n\n  * MDS with excess blasts (\\>10%)\n  * MDS with blasts \\\u003C10% with high-risk features\n  * MDS refractory to initial treatment\n  * Relapsed MDS\n  * MDS\u002FAML: May be newly diagnosed or relapsed\u002Frefractory disease.\n  * Therapy related myeloid neoplasm (tMDS\u002FAML): May be initial or relapsed\u002Frefractory disease.\n\n    * Note: MDS or MDS\u002FAML may be derived from a germline predisposition to myeloid malignancy as long as that condition does not confer increased toxicity to treatment.\n* Age ≤ 40 years of age, except the following subjects that must be \\\u003C18 years to enroll\n\n  * Subjects with MDS\u002FAML that have not received prior therapy\n  * Subjects enrolled onto Dose level -2.\n* Lansky\u002FKarnofsky performance status ≥ 50%\n* Participants must have fully recovered from the acute toxic effects of all and meet all of the following criteria:\n\n  * Myelosuppressive chemotherapy: 14 days, or 5 half-lifes (whichever is shorter) must have elapsed since the completion of myelosuppressive therapy. Individuals may have received any of the following medications without a \"wash-out\" period\n\n    * Standard maintenance therapy: dexamethasone\u002Fprednisone, vincristine, 6MP, low dose methotrexate)\n    * Hydroxyurea\n    * Intrathecal chemotherapy with methotrexate, hydrocortisone and\u002For cytarabine.\n  * Radiation therapy (XRT):\n\n    * Total Body Irradiation (TBI) or cranial radiation therapy: Must have been completed more than 90 days prior to study entry\n    * XRT for chloroma does not require a washout period.\n    * Palliative XRT does not require a washout\n  * Small molecule inhibitors (BCR-ABL or FLT3 inhibitors, for example): 7 days, or 5 half-lifes, whichever is shorter) must have elapsed since the completion of therapy. 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.\n  * Immunotherapy: At least 30 days after the administration of any type of immunotherapy, including, but not limited to, tumor vaccines, chimeric antigen receptor (CAR) therapy, other immune effector cell therapy and checkpoint inhibitors.\n  * Monoclonal antibodies: At least 3 half-lives of the antibody\n  * Prior hematopoietic stem cell transplant (HSCT):\n\n    * Allogeneic HSCT \\> 90 days of study entry\n    * No evidence of graft-versus-host-disease (GVHD)\n  * Adequate organ function, as defined by\n\n    * Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN)\n    * Direct bilirubin ≤ 3X\n    * Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram.\n  * Female participants of childbearing potential must have a negative urine or serum HCG prior to study entry and at the start of therapy. All females of childbearing potential must refrain from breastfeeding during study participation, and all male and females of childbearing potential must agree to use an effective form of contraception (abstinence, hormonal, or barrier) prior to study entry, for duration of participation, and for a minimum of 30 days following the last dose of treatment.\n\nCohort B Inclusion Criteria\n\n* MDS, MDS\u002FAML, therapy related myeloid neoplasm (tMDS\u002FAML) that is derived from the following germline disorders:\n\n  * Dyskeratosis Congenita or associated telomeropathies\n  * Fanconi Anemia\n  * Nijmegen Breakage\n  * Other related disorders with high risk of toxicity may be eligible for this cohort after discussion with the Sponsor-Investigator.\n* And meets at least one the following disease characteristics:\n\n  * MDS with excess blasts (\\>10%)\n  * MDS with blasts \\\u003C10% with high-risk features\n  * MDS refractory to initial treatment\n  * Relapsed MDS\n  * MDS\u002FAML: May be newly diagnosed or relapsed\u002Frefractory disease.\n  * Therapy related myeloid neoplasm (tMDS\u002FAML): May be initial or relapsed\u002Frefractory disease.\n* Age ≤ 40 years of age\n* Lansky\u002FKarnofsky performance status ≥ 50%\n* Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and meet all of the following criteria:\n\n  * Myelosuppressive chemotherapy: 14 days, or 5 half-lifes (which ever is shorter) must have elapsed since the completion of myelosuppressive therapy. Individuals may have received any of the following medications without a \"wash-out\" period\n\n    * Standard maintenance therapy: dexamethasone\u002Fprednisone, vincristine, 6MP, low dose methotrexate\n    * Hydroxyurea\n    * Intrathecal chemotherapy with methotrexate, hydrocortisone and\u002For cytarabine.\n  * Radiation therapy (XRT):\n\n    * Total Body Irradiation (TBI) or cranial radiation therapy: Must have been completed more than 90 days prior to study entry\n    * XRT for chloroma does not require a washout period.\n    * Palliative XRT does not require a washout\n  * Small molecule inhibitors (BCR-ABL or FLT3 inhibitors, for example): 7 days, or 5 half-lifes, whichever is shorter) must have elapsed since the completion of therapy. 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.\n  * Immunotherapy: At least 30 days after the administration of any type of immunotherapy, including, but not limited to, tumor vaccines, chimeric antigen receptor (CAR) therapy, other immune effector cell therapy and checkpoint inhibitors.\n  * Monoclonal antibodies: At least 3 half-lives of the antibody\n  * Prior hematopoietic stem cell transplant (HSCT): Must meet all of the following conditions:\n\n    * Allogeneic HSCT \\> 90 days of study entry\n    * No evidence of graft-versus-host-disease (GVHD)\n* Adequate organ function, as defined by\n\n  * Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN)\n  * Direct bilirubin ≤ 3X upper limit of normal for age and institution.\n* Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram.\n* Because of the teratogenic effects of venetoclax on developing fetuses, female participants of childbearing potential must have a negative urine or serum HCG prior to study entry and at the start of therapy. All females of childbearing potential must refrain from breastfeeding during study participation, and all male and females of childbearing potential must agree to use an effective form of contraception (abstinence, hormonal, or barrier) prior to study entry, for duration of participation, and for a minimum of 30 days following the last dose of treatment.\n\nCohort C Inclusion Criteria\n\n* Part I: B-cell or T-cell acute lymphoblastic leukemia (ALL), mixed phenotype acute lymphoblastic leukemia (MPAL) or lymphoblastic lymphoma (LBL) in first or greater relapse or refractory to at least 1 prior remission induction attempt.\n\n  * For ALL\u002FMPAL: Bone marrow involvement ≥ 5% by aspirate morphology or ≥ 1% assessable by flow cytometry or validated molecular minimal residual disease (MRD) testing\n  * For LBL: Radiographically detectable mass or lymph node involvement\n* Part II: Histologically confirmed diagnosis of one of the following:\n\n  * T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) in first or greater relapse or refractory to at least 1 prior remission induction attempt.\n\n    * For T-ALL: Bone marrow involvement ≥ 5% by aspirate morphology or ≥ 1% assessable by morphology, flow cytometry or validated MRD testing\n    * For T-LBL (biopsy proven at current or prior relapse): Radiographically detectable mass or lymph node involvement OR\n  * Relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) with bone marrow involvement ≥1% (assessable by morphology, flow cytometry or validated MRD testing) and at least one of the following characteristics:\n\n    * First relapse with adverse biologic determinants as described below:\n\n      * KMT2A rearrangement\n      * Low hypodiploidy, defined as ≤ 40 chromosomes\n      * t(17;19)\n      * IKZF1 deletion (without targetable ABL1 fusion)\n      * Ph-like ALL (without targetable ABL1 fusion)\n      * Other biologic determinants with adverse prognosis in discussion with the Sponsor-Investigator\n    * Early first bone marrow relapse occurring \\\u003C36 months from initial diagnosis\n    * Primary refractory ALL that has failed 1 prior induction attempt\n* Age: ≥ 1 and ≤ 21 years of age\n* Lansky\u002FKarnofsky performance status ≥ 50%\n* Participants must have fully recovered from the acute toxic effects of all prior and meet all of the following criteria:\n\n  * Myelosuppressive chemotherapy: 14 days, or 5 half-lives, whichever is shorter, must have elapsed since the completion of myelosuppressive therapy. Individuals may have received any of the following medications without a \"wash-out\" period:\n\n    * Standard maintenance therapy: dexamethasone\u002Fprednisone, vincristine, 6MP, low dose methotrexate\n    * Hydroxyurea\n    * Intrathecal chemotherapy with methotrexate, hydrocortisone and\u002For cytarabine.\n  * Radiation therapy (XRT):\n\n    * Total Body Irradiation (TBI) or cranial radiation therapy: Must have been completed more than 90 days prior to study entry\n    * XRT for chloroma does not require a washout period.\n    * Palliative XRT does not require a washout\n  * Small molecule inhibitors (BCR-ABL or FLT3 inhibitors, for example): 7 days, or 5 half-lifes, whichever is shorter) must have elapsed since the completion of therapy. 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.\n  * Immunotherapy: At least 30 days after the administration of any type of immunotherapy, including, but not limited to, tumor vaccines, chimeric antigen receptor (CAR) therapy, other immune effector cell therapy and checkpoint inhibitors.\n  * Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody\n  * Prior hematopoietic stem cell transplant (HSCT): Patients who have received HSCT are eligible, but must meet all of the following conditions:\n\n    * Allogeneic HSCT \\> 90 days of study entry\n    * No evidence of graft-versus-host-disease (GVHD)\n* Adequate organ function, as defined by the following laboratory values:\n\n  * Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN), unless deemed secondary to leukemic involvement in discussion with site PI.)\n  * Direct bilirubin ≤ 3X upper limit of normal for age and institution.\n  * Serum amylase ≤ 3X institutional ULN .\n* Cardiac function as defined as below:\n\n  * Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram.\n  * Maximum prior cumulative doxorubicin dose ≤ 360 mg\u002Fm2 or equivalent\n* Because of the teratogenic effects of venetoclax on developing fetuses, female participants of childbearing potential must have a negative urine or serum HCG prior to study entry and at the start of therapy. All females of childbearing potential must refrain from breastfeeding during study participation, and all male and females of childbearing potential must agree to use an effective non-hormonal form of contraception (abstinence, barrier) prior to study entry, for duration of participation, and for a minimum of 3 months following the last dose of treatment (as calaspargase pegol can render hormonal contraceptives ineffective).\n\nExclusion Criteria\n\nCohort A Exclusion Criteria\n\n* Use of strong or moderate CYP3A inhibitors\u002Finducers within 3 days of study entry\n* Individuals who have had a stem cell transplant and are still receiving treatment for GVHD or GVHD prophylaxis, or who have evidence of acute GVHD\n* Individuals with known active hepatitis; baseline testing not required.\n* Patients with systemic infection that is exhibiting ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics or other treatment.\n* Patients known to have human immunodeficiency virus (HIV) infection; baseline testing for HIV is not required.\n* Pregnant or nursing women are excluded.\n* Individuals with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.\n\nCohort B Exclusion Criteria\n\n* Use of strong or moderate CYP3A inhibitors\u002Finducers within 3 days of study entry\n* Individuals who have had a stem cell transplant and are still receiving treatment for GVHD or GVHD prophylaxis, or who have evidence of acute GVHD\n* Individuals with known active hepatitis; baseline testing not required.\n* Patients with systemic infection that is exhibiting ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics or other treatment.\n* Patients known to have human immunodeficiency virus (HIV) infection; baseline testing for HIV is not required.\n* Pregnant or nursing women are excluded.\n* Individuals with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.\n\nCohort C Exclusion Criteria\n\n* Use of strong or moderate CYP3A inhibitors\u002Finducers within 3 days of study entry\n* Individuals who have had a stem cell transplant and are still receiving treatment for GVHD or GVHD prophylaxis, or who have evidence of acute GVHD, or who are less than 90 days from stem cell infusion\n* Individuals with known active hepatitis; baseline testing not required.\n* Patients with systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics or other treatment.\n* Patients known to have human immunodeficiency virus (HIV) infection; baseline testing for HIV is not required.\n* Pregnant or nursing women are excluded\n* Individuals with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.\n* Individuals with a history of allergic reactions to any of the agents being used in this trial, with the exception of pegaspargase or calaspargase pegol. Participants with a history of allergy to pegylated formulation of asparasginase are allowed on study but should receive commercial supply of asparaginase Erwinia chrysanthemi (Erwinaze), crisantaspase (Erwinase), or asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) instead of calaspargase pegol (see Sections 6.2.6 and 6.2.7). Individuals with a history of allergy to Erwinaze, Erwinase or Rylaze are excluded from the study.\n* History of asparaginase-associated pancreatitis.\n* Known, active and propagating deep venous thrombus (DVT).\n* Individuals with isolated CNS or testicular relapse.\n* Presence of surface immunoglobulin by flow cytometry and\u002For known t(8;14), t(2;8), or t(8;22).\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances:\n\n  * Individuals are eligible if they have been disease-free for at least 1 year and are deemed by the investigator to be at low risk for recurrence of that malignancy.\n  * Individuals with the following cancers are eligible if diagnosed and treated within the past year: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.","40 Years",{"count":59,"type":20},30,[61],"PHASE1","This trial is evaluating the safety and tolerability of venetoclax with chemotherapy in pediatric and young adult patients with hematologic malignancies, including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS\u002FAML), and acute lymphoblastic leukemia (ALL)\u002Flymphoblastic lymphoma (LBL).\n\nThe names of the study drugs involved in this study are below. Please note this is a list for the study as a whole, participants will receive drugs according to disease cohort.\n\n* Venetoclax\n* Azacitidine\n* Cytarabine\n* Methotrexate\n* Hydrocortisone\n* Leucovorin\n* Dexamethasone\n* Vincristine\n* Doxorubicin\n* Dexrazoxane\n* Calaspargase pegol\n* Hydrocortisone",[64,65,66,67,68,69,30,70,71,72,73],"Myelodysplastic Syndromes, de Novo","Myelodysplastic Syndromes, Secondary","Myelodysplastic Syndromes, Previously Treated","Treatment-Related Acute Myeloid Leukemia","Therapy-Related Myelodysplastic Syndrome","Acute Lymphoblastic Leukemia, in Relapse","Lymphoblastic Lymphoma, in Relapse","Lymphoblastic Lymphoma, Refractory","Acute Leukemia of Ambiguous Lineage in Relapse","Acute Leukemia of Ambiguous Lineage",[75,76,77,78,79,80,81,82],"Myelodysplastic Syndrome (MDS)","Treatment-related Acute Myelogenous Leukemia","AML arising from MDS","Relapsed or Refractory Acute Lymphoblastic Leukemia","Relapsed or Refractory Acute Lymphoblastic Lymphoma","Relapsed or Refractory MDS","Treatment-related MDS","Relapsed or Refractory Acute leukemia of ambiguous lineage","2026-03-10",{"date":85,"type":41},"2026-03-12",{"date":87,"type":41},"2023-03-29",{"date":89,"type":20},"2030-07-02",{"name":91,"class":48},"Andrew E. Place, MD",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":103,"conditions":104,"keywords":109,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":49},"100499182","early-phase-1-safety-and-feasibility-of-cd19-car-t-cells-using-clinimacs-prodigy-for-relapsedrefractory-cd19-positive-all-and-nhl-100499182","NCT05779930","Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed\u002FRefractory CD19 Positive ALL and NHL","Safety and Feasibility of On-Site Manufacture of CD19 CAR T Cells Using the CliniMACS Prodigy in Pediatric and Young Adult Patients With Relapsed\u002FRefractory CD19 Positive Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma","Eligible Diseases:\n\nRelapsed or refractory pediatric B-Cell ALL as defined by at least one of the following criteria:\n\n* Second or greater relapse OR\n* Any relapse after allogeneic SCT OR\n* Not achieving a CR after 2 cycles of standard chemotherapy regimen (including persistent MRD positive disease) OR\n* Not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia (including persistent MRD positive disease) OR\n* Patients with Philadelphia chromosome positive (Ph+) ALL who are intolerant or have failed 3 lines of tyrosine kinase inhibitor (TKI) therapy, or if TKI therapy is contraindicated OR\n* Patients who meet accepted indications for allogeneic HSCT for pediatric ALL but are deemed unfit for HSCT by their treating physician are eligible for this study. This includes high risk patients in first relapse.\n\nPatients with relapsed or refractory pediatric B cell non-Hodgkin's Lymphoma as defined by:\n\n* Refractory to second-line or later lines of standard chemotherapy OR\n* Patients with residual disease after primary therapy and not eligible for autologous SCT OR\n* Any relapse after previous allogeneic or autologous SCT OR\n* Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT\n\nNote: patients with a history of blinatumomab therapy are eligible for this study.\n\nInclusion Criteria:\n\n* For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry at most recent relapse or reconfirmed after CD19 directed therapy in ALL patients. For patients with NHL, documentation of CD19 positivity must be available from biopsy at diagnosis or most recent tumor biopsy.\n* Age 0 to age 30 at the time of initial diagnosis. Note: the first three subjects enrolled must be ≥16 years of age\n* Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n* Patients with active CNS leukemia involvement defined as CNS-3 by CSF findings only are eligible but will have their infusion delayed until CNS disease is reduced to CNS-1 or CNS-2 by CSF findings. Patients with other forms of active CNS-3 leukemic involvement such as CNS parenchymal or ocular disease, cranial nerve involvement or significant leptomeningeal disease are eligible if there is documented evidence of disease stabilization for at least 1 month prior to CD19 CAR T cell infusion.\n* Meets criteria for non-hematopoietic organ function:\n\n  * Renal function: Estimated glomerular filtration rate ≥60 mL\u002Fmin x appropriate estimation of patient's body surface area m2\u002F1.73m2 using the modified Schwartz formula for pediatric patients and Crockcoft Gault formula for adults.\n  * Liver function: Total bilirubin ≤ 2 mg\u002Fdl or ≤ 2.5 x ULN for age (unless Gilbert's syndrome) and ALT and AST ≤ 5 x ULN for age (unless related to leukemic involvement)\n  * Cardiac function: left ventricular ejection fraction ≥40%\n  * Pulmonary function: minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \\>91% on room air\n* Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the Investigator.\n* Signed consent by parent\u002Fguardian and assent if appropriate for subjects \\\u003C 18 years of age. Signed consent by patient\u002Fsubject if ≥18 years of age.\n\nExclusion Criteria:\n\n* Acute\u002Fongoing neurologic toxicity \\> Grade 1 with the exception of a history of controlled seizures or fixed neurologic deficits that have been stable\u002Fimproving over the past 1 months.\n* Active untreated infection. Viremia by PCR analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic.\n* Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.\n* Presence of Grade 2 to 4 acute or extensive chronic graft versus-host disease (GVHD) at the time of enrollment\n* Patient has participated in an investigational research study using an investigational agent within the last 30 days prior to screening\n* Pregnant or nursing (lactating) women.\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* HIV positive test within 8 weeks of screening\n* Allogeneic HSCT within 3 months of enrollment\n* Any prior CD19 CAR T cell therapy","30 Years",{"count":19,"type":20},[102],"EARLY_PHASE1","This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.\n\nPatients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 CAR T cell infusion. The lymphodepleting chemotherapy is administered over four days IV to prepare the body for the CAR T cells. The anti-CD19 CAR-T cells are infused between 2-14 days after the last dose of chemotherapy. This study is designed for participants to begin lymphodepleting chemotherapy during the CAR T cell manufacture and receive a fresh cell infusion on the day that manufacturing is complete. Some patients may need more time in between the cell collection and the CAR T cell infusion, therefore, the cells may be manufactured and frozen prior to administration. Patients will be followed for a year after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.",[69,105,106,30,107,108],"Non-Hodgkin's Lymphoma, Relapsed","Non-Hodgkin's Lymphoma Refractory","B-cell Non Hodgkin Lymphoma","B Cell Leukemia",[16,110,111],"NHL","CD19 CAR T cells","NOT_YET_RECRUITING","2025-08-13",{"date":115,"type":41},"2025-08-15",{"date":117,"type":20},"2025-10",{"date":119,"type":20},"2035-12",{"name":121,"class":48},"Nationwide Children's Hospital",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":49},"100518747","phase-2-bortezomib-based-regimen-for-refractory-or-relapsed-acute-lymphoblastic-leukemia-100518747","NCT06034561","Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia","Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia in Adults","Inclusion Criteria:\n\n* Patients between 16 and 60 years-old with refractory or relapsed ALL (≥1% of anomalous blasts by flow cytometry in bone marrow or peripheral blood) after one or two lines of therapy, regardless of their phenotype or baseline genetic alteration;\n* Patients are eligible after allogeneic HSCT as long as patients are not actively being treated for graft-versus-host-disease (GvHD).\n\nExclusion Criteria:\n\n* Burkitt leukemia;\n* Prior myeloproliferative disease;\n* Drug allergies;\n* Eastern Cooperative Oncology Group (ECOG) scale \\>2;\n* Total bilirubin\\>2x upper limit of normal (ULN);\n* Transaminases\\>5x ULN;\n* Creatinine\\>2,5 mg\u002Fdl;\n* Active uncontrolled infection;\n* History of asparaginase-induced pancreatitis;\n* Prior exposure to bortezomib;\n* Heart failure New York Heart Association (NYHA) Class III or IV;\n* Patients with more than 400mg\u002Fm2 lifetime exposure of anthracycline;\n* Severe psychiatric disorder which prevents adequate compliance;\n* Refusal to participate in the study.","16 Years","60 Years",{"count":132,"type":20},50,[134],"PHASE2","This is a interventional phase II study aiming to examine the complete response rate of a bortezomib-based salvage regimen in adults with refractory or relapsed acute lymphoblastic leukemia (ALL), seeking to compare outcomes with the available literature and with our historical data on relapsed\u002Frefractory ALL.",[69,30],[138,139,140,141,142],"Acute lymphoblastic leukemia","Bortezomib","Salvage therapy","Bridge therapy","Response rate","2025-05-13",{"date":145,"type":41},"2025-05-16",{"date":147,"type":41},"2024-04-01",{"date":149,"type":20},"2029-08",{"name":151,"class":48},"Instituto do Cancer do Estado de São Paulo",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100550340","phase-1-cd19cd22-car-t-cells-in-adults-with-rr-all-or-nhl-100550340","NCT06445803","CD19\u002FCD22 CAR-T Cells in Adults With R\u002FR ALL or NHL","A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19\u002FCD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Male or female,≥18 years old;\n* Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):\n\n(B-NHL)\n\n1. Second or greater relapse (CD20 regimens must be included) OR\n2. Refractory to first-line chemotherapy or relapse within 1 year OR\n3. Relapse within 1 year of auto-HSCT.\n4. With measurable or evaluable lesions（Dose expansion cohort） (B-ALL)\n\na. Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR\u002FCRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs.\n\n* ECOG 0\\~2\n* Estimated survival time ≥ 12 weeks;\n* Main tissues and organs function well.\n\nExclusion Criteria:\n\n* Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg\u002Fd or equivalent) within 72 h\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy；\n* active bleeding, or venous thromboembolic event\n* Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs\n* Central nervous system (CNS) disease or symptoms of CNS involvement\n* Pregnant or nursing (lactating) women\n* Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2 neuropathy excluded\n* Any Iinappropriate conditions in the opinion of the PI .","18 Years",{"count":161,"type":20},48,[61],"This study examines the safety, tolerability and preliminary efficacy of anti-CD19 \u002FCD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.",[69,30,165,166],"B-cell Lymphoma Refractory","B-cell Lymphoma Recurrent",[168],"CAR-T therapy","2024-06-01",{"date":171,"type":41},"2024-06-06",{"date":173,"type":41},"2024-05-31",{"date":175,"type":20},"2026-12",{"name":177,"class":48},"Rong Tao",2]