[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-acute-lymphoblastic-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,71,95,117,138,166,195],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100572830","phase-2-etoposide-prednisone-vincristine-cyclophosphamide-and-doxorubicin-da-epoch-with-or-without-rituximab-plus-recombinant-erwinia-asparaginase-jzp458-for-the-treatment-of-newly-diagnosed-ph-negative-b-acute-lymphoblastic-leukemia-or-t-acute-lymphoblastic-leukemia-100572830",false,"NCT06738368","Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia","Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative Acute Lymphoblastic Lymphoma\u002FLeukemia","Inclusion Criteria:\n\n* Adults (age 18 years and older) with newly-diagnosed Ph- B-ALL or T-ALL\n* In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., ≥ 40 years), practical\u002Flogistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen\n* Marrow or blood involvement by ALL detectable by multi-parameter flow cytometry (MFC)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. (Performance status of 3 will be allowed if poor performance status is thought to be directly secondary to ALL.)\n* Total bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be ≤ 4.0 x ULN) (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and alanine aminotransferase \\[ALT\\]\u002Faspartate aminotransferase \\[AST\\] are ≤ 8.0 x ULN.)\n* AST (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002FALT (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5.0 x institutional ULN. (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and ALT\u002FAST are ≤ 8.0 x ULN.)\n* Calculated creatinine clearance of ≥ 60 ml\u002Fmin\u002F1.73 m\\^2, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible\n* As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment. However, adequate recovery of blood counts will be required to receive subsequent cycles\n* Ability to give informed consent and comply with the protocol\n* Anticipated survival of at least 3 months, independent of ALL\n* Female subjects of childbearing potential should use effective non-hormonal contraceptive methods during treatment with JZP458 and for 3 months after the last dose of study drug. Male subjects with female partners of childbearing potential must agree to use an effective method of birth control from the time of signing the consent form until at least 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n* Prior systemic therapy for ALL except to control acute symptoms and\u002For leukocytosis (e.g., corticosteroids, cytarabine, etc.). Cytarabine 500 mg\u002Fm\\^2 per dose up to 2 doses and\u002For the equivalent of prednisone 50 mg\u002Fm\\^2\u002Fday for up to 2 days are permitted\n* Burkitt lymphoma\u002Fleukemia\n* Isolated extramedullary or known parenchymal central nervous system (CNS) disease\n* Known hypersensitivity or intolerance to any of the agents under investigation\n* Known history of grade 3+ pancreatitis or chronic pancreatic insufficiency\n* Known active chronic liver disease including, but not limited to, non-alcoholic steatohepatitis, cirrhosis, or non-alcoholic fatty liver disease\n* Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol\n* Pregnant or nursing\n\n  * Pregnancy test is only required in women, unless they are highly unlikely to conceive (defined as \\[1\\] surgically sterilized, or \\[2\\] postmenopausal \\[i.e., a woman who is \\> 50 years old or who has not had menses for ≥ 1 year\\], or \\[3\\] not heterosexually active)","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly diagnosed Philadelphia chromosome (Ph) negative B-acute lymphoblastic leukemia (ALL) or T-ALL. Chemotherapy drugs, such as etoposide, vincristine, cyclophosphamide and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving DA-EPOCH with or without rituximab plus JZP458 may kill more cancer cells in patients with newly diagnosed Ph negative B-ALL or T-ALL.",[26,27],"B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","T Acute Lymphoblastic Leukemia","RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2026-05-08",{"date":36,"type":20},"2028-07-30",{"name":38,"class":39},"University of Washington","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100598522","phase-2-testing-the-addition-of-daratumumab-to-chemotherapy-for-treating-patients-with-newly-diagnosed-t-cell-lymphoblastic-leukemia-t-all-and-t-cell-lymphoblastic-lymphoma-t-ll-100598522","NCT07072585","Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)","A Phase 2\u002F3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrolled on AALL2331.\n* Patients must be \\> 365 days and \\\u003C 21 years of age at the time of diagnosis.\n* \\* Newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-lineage lymphoblastic lymphoma (T-LL) stages II-IV.\n\n  * Note: A diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (CD19\u002FCD22\u002FCD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a, and are present either in peripheral blood or \\> 25% in the bone marrow. If surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including TdT, CD34 or CD99 will be assessed for expression. Cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory.\n  * For T-LL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL. For tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LL defined by the submitting institution will be accepted.\n\nExclusion Criteria:\n\n* Diagnosis of Down syndrome (trisomy 21).\n* Patients with known Charcot-Marie-Tooth disease.\n* \\* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-LL or for any cancer diagnosis prior to the initiation of protocol therapy on AALL2331 with the exception of:\n\n  * Steroid pretreatment: Prednisone or methylprednisolone for ≤ 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for ≤ 336 hours (14 days) in the 28 days prior to initiation of protocol therapy does not affect eligibility.\n  * Intrathecal cytarabine; or\n  * Pretreatment with hydroxyurea; or\n  * 600 cGy of chest irradiation, if medically necessary.\n  * Pre-treatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during sedation to prevent or treat airway edema. Patients who receive a single dose of dexamethasone to prevent or treat airway edema in the 28 days preceding diagnosis are eligible for this study.\n* \\* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n\n  * Lactating females who plan to breastfeed their infants.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.\n* Known severe persistent asthma anytime in the previous two years or uncontrolled asthma of any classification.\n* Peripheral neurotoxicity: Pre-existing ≥ grade 2 sensory or motor peripheral neurotoxicity.\n* Seizure disorder: Patients must not have an uncontrolled seizure disorder. Patients with a seizure history or a controlled seizure disorder are eligible. A controlled seizure disorder is defined as having stable or decreasing symptoms over the past 3 months without anti-epileptic medications or is on a stable or decreasing dose of anti-epileptic medication.\n* \\* Patients who are previously known to be seropositive for HIV except for HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment on this trial.\n\n  * Patients with evidence of chronic hepatitis B (HBV) infection, except for patients who have an HBV viral load that is undetectable on suppressive therapy.\n  * Patients with a history of hepatitis C virus (HCV) infection, except for those patients who have been treated and cured, or patients who are currently on HCV treatment who have an undetectable HCV viral load.\n* Patients with significant hepatic dysfunction defined as those with an alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) \\> 10x upper limit of normal (ULN) or direct bilirubin \\> 2x ULN unless the patient has known Gilbert's syndrome or has hepatic involvement from leukemic or lymphomatous infiltration.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.","365 Days","21 Years",{"count":51,"type":20},1708,[23,53],"PHASE3","This phase II\u002FIII trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.",[56,57,58,27,59],"Stage II T Lymphoblastic Leukemia\u002FLymphoma","Stage III T Lymphoblastic Leukemia\u002FLymphoma","Stage IV T Lymphoblastic Leukemia\u002FLymphoma","T Lymphoblastic Lymphoma","NOT_YET_RECRUITING","2026-06-15",{"date":63,"type":32},"2026-06-17",{"date":65,"type":20},"2026-08-28",{"date":67,"type":20},"2035-09-01",{"name":69,"class":70},"Children's Oncology Group","NETWORK",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":4},"100642839","phase-2-testing-blinatumomab-with-or-without-revumenib-in-patients-with-b-cell-acute-lymphoblastic-leukemia-with-a-genetic-change-requiring-more-treatment-100642839","NCT07636564","Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment","A Phase II Randomized Study of Blinatumomab With or Without Revumenib for Patients With KMT2A-Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)\u002F Acute Leukemia With Ambiguous Lineage (ALAL) With Persistent Measurable Residual Disease (MRD)","Inclusion Criteria:\n\n* COHORT A: Participants must meet diagnostic criteria for either B-cell acute lymphoblastic leukemia (ALL) with KMT2A-translocation or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation\n* COHORT A: Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)\n* COHORT A: Participants must have achieved morphological first complete remission (CR1) after induction cycle (s) as defined bone marrow lymphoblasts \\\u003C 5%\n* COHORT A: Participants must have either known trackable clone(s) by clonoSEQ that was identified at initial diagnosis, or a banked diagnostic sample, which can include clinical samples from the treating institution, available that can be used to identify trackable clone(s)\n\n  * Participants must not be known not to have trackable clones by clonoSEQ\n  * Participants must not be known already to have MRD-negativity by clonoSEQ prior to enrollment\n* COHORT A: Participants must have evidence of CD19 expression at any level in ALL or ALAL documented locally by flow cytometry or immunohistochemistry in bone marrow or peripheral blood at the time of initial diagnosis. Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage. Appropriate marker studies including CD19 (B cell) must be performed. If a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate Immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage\n* COHORT A: Participants must have Philadelphia-chromosome negative ALL or ALAL\n* COHORT A: Participants must not have known lymphoid blast crisis arising from chronic myeloid leukemia (CML) or have received previous tyrosine kinase inhibitor (TKI) therapy for their chronic myeloid leukemia (CML)\n* COHORT B: Participants must meet diagnostic criteria for either newly diagnosed with acute lymphoblastic leukemia (ALL) or acute leukemia with ambiguous lineage (ALAL)\n\n  * Participants with either B or T-cell subtypes of ALL are permitted on Cohort B\n  * Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)\n* COHORT B: Participants must have Philadelphia-chromosome negative ALL or ALAL\n* COHORT B: Participants must not have known lymphoid blast crisis arising from CML or have received previous TKI therapy for their chronic myeloid leukemia (CML)\n* COHORT A: Participants ≥ 18 years may have received 1 to 3 cycles of induction\u002Fconsolidation before entering the study. It is encouraged to enroll participants immediately after completing the first induction cycle if the patient achieves morphological CR. For pediatric patients \\\u003C 18 years of age, enrollment must occur after induction therapy\n* COHORT A: Participants must discontinue strong cytochrome P450 (CYP)3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration\n* COHORT A: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator\n\n  * Note: Central venous access placement is not considered major surgery for the purposes of this protocol\n* COHORT A: Participants must not be receiving any oral or intravenous systemic immunosuppressive therapy with the exception of induction\u002Fconsolidation chemotherapy for the treatment of their current ALL or ALAL. Participants may receive up to 10 mg per day of prednisone or prednisone equivalent for adrenal insufficiency or other indications\n* COHORT A: Participants must not have received a prior allogeneic hematopoietic stem cell transplant\n* COHORT A: Participants must not have received prior blinatumomab, menin inhibitors, chimeric antigen receptor (CAR)-T therapy, or anti-CD19 antibodies\n* COHORT B: Participants must not have received prior systemic therapy for ALL or ALAL, with the exception of hydroxyurea, steroid, retinoic acid, intrathecal chemotherapy, or induction chemotherapy as defined below\n\n  * Participants who have been started on the study regimen backbone (i.e. induction therapy) before consenting and then are found to have the KMT2Ar and are eligible for the study, can be enrolled on the study as long as revumenib treatment can be started by day 8 of induction therapy\n* COHORT B: Participants must discontinue strong CYP3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration\n* COHORT B: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator\n\n  * Note: Central venous access placement is not considered major surgery for the purposes of this protocol\n* COHORT B: Participants must not be receiving any systemic oral or intravenous immunosuppressive therapy with the exception of induction chemotherapy or corticosteroid for the treatment of their current ALL or ALAL\n* COHORT B: Participants must not have received a prior allogeneic hematopoietic stem cell transplant\n* COHORT A: Participant must be ≥ 1 years old at the time of registration. There is no upper age limit\n* COHORT A: Participant must have Zubrod\u002FEastern Cooperative Oncology Group (ECOG) performance status of 0-2, or Lansky\u002FKarnofsky performance status scores of 50-100\n* COHORT A: Participants must have a complete medical history and physical exam within 28 days prior to registration\n* COHORT A: Glomerular filtration rate (GFR) ≥ 50 ml\u002Fmin\u002F1.73 m\\^2 (within 14 days prior to registration)\n* COHORT A: Absolute neutrophil count ≥ 1 x 10\\^3\u002FuL (within 14 days prior to registration)\n* COHORT A: Platelets ≥ 100 x 10\\^3\u002FuL (within 14 days prior to registration)\n* COHORT A: Direct bilirubin ≤ 2.0 mg\u002FdL (34.2 micromoles\u002FL) (within 14 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease must have direct bilirubin ≤ 5 x institutional upper limit of normal (ULN)\n* COHORT A: Alanine aminotransferase (ALT) ≤ 5 x institutional ULN (within 14 days prior to registration)\n* COHORT A: Participants ≥ 18 years must have a calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration\n* COHORT A: Adequate renal function for participants \\\u003C 18 years of age is defined as:\n\n  * A GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2, as determined by one of the following methods:\n\n    * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 \"Bedside\" Schwartz formula (2009)\n    * Measured GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard)\n* COHORT A: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2 dimensional (2-D) echocardiogram or shortening fraction (SF) ≥ 27% by echocardiogram within 90 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* COHORT A: Participants ≥ 18 years of age with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* COHORT A: Participants ≥ 18 years of age with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT A: Participants ≥ 18 years of age with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT A: Participants must not have prolonged Fridericia's formula-corrected QT interval (QTcf) defined as \\> 450 msec on screening electrocardiogram (EKG) prior to registration\n* COHORT A: Participants must not have relapsed or refractory disease in the bone marrow (≥ 5% blasts) or extramedullary sites involvement\n* COHORT A: Participants must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator\n* COHORT A: Participants must not have clinically significant autoimmune disease\n* COHORT A: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via nasogastric\u002Fgastrostomy (NG\u002FG)-tube is acceptable as long as oral solution is used\n* COHORT A: Participants must not have uncontrolled intercurrent illness including, but not limited to:\n\n  * Active central nervous system status 3 (CNS3) or CNS2 (CNS leukemia)\n\n    * Note: Participants with CNS1 or who had prior CNS2 or CNS3 are eligible if this has cleared and have become CNS-1\n  * Currently requiring supplemental oxygen (more than 2 liters per minute), mechanical ventilation, vasopressors\n* COHORT A: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* COHORT A: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n\n  * Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment\n* COHORT B: Participant must be ≥ 55 years old at the time of registration\n* COHORT B: Participant must have Zubrod\u002FECOG performance status of 0-2\n* COHORT B: Participants must have a complete medical history and physical exam within 28 days prior to registration\n* COHORT B: GFR ≥ 50 ml\u002Fmin\u002F1.73 m\\^2 (within 14 days prior to registration)\n* COHORT B: Direct bilirubin ≤ 2.0 mg\u002FdL (34.2 micromoles\u002FL) (within 14 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease or elevated bilirubin is related to underlying leukemia must have direct bilirubin ≤ 5 x institutional ULN\n* COHORT B: ALT ≤ 5 x institutional ULN unless abnormal liver tests are related to underlying leukemia (within 14 days prior to registration)\n* COHORT B: Participants must have a calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration\n* COHORT B: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2-D echocardiogram within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* COHORT B: Participants with a known history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* COHORT B: Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT B: Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT B: Participants must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration. Intrathecal cytarabine and\u002For methotrexate administered prior to study registration may count as the first dose of intrathecal therapy required as part of protocol therapy\n* COHORT B: Participants must not have an active uncontrolled infection\n* COHORT B: Participants must not have prolonged QTcf defined as \\> 450 msec participants on screening EKG prior to registration\n* COHORT B: Participants must not have known clinical signs of bulk central nervous system involvement (CNS3c), such as facial palsy, brain\u002Feye involvement or hypothalamic syndrome\n* COHORT B: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via NG\u002FG-tube is acceptable as long as oral solution is used\n* COHORT B: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* COHORT B: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n\n  * Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment\n* ALL COHORTS: Participants must be offered the opportunity to participate in specimen collection submitted for translational medicine work. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n  * This trial will use a slot reservation system to enroll the feasibility and safety run-in portions of the study for Cohort A and Cohort B. Patients planning to enroll at this portion of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation","1 Year",{"count":80,"type":20},90,[23],"This phase II trial tests how well adding revumenib to usual treatment (blinatumomab) compared to usual treatment alone works in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation. Revumenib binds to a protein called menin and keeps it from binding to another protein called KMT2A. This stops or slows the growth of leukemia cells with changes in the KMT2A gene. Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. In addition to blinatumomab, usual treatment also includes dexamethasone, methotrexate, cyclophosphamide, cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, daunorubicin, vincristine and leucovorin. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Chemotherapy drugs, such as cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Leucovorin is also being studied in the treatment of cancer. It is a type of chemoprotective agent and a type of chemosensitizing agent. Adding revumenib to usual treatment with blinatumomab may be safe, tolerable and more effective than blinatumomab alone in lowering the amount of leukemia in patients with B-ALL or ALAL with the KMT2A translocation.",[84,85,26,27],"Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia","2026-06-03",{"date":88,"type":32},"2026-06-09",{"date":90,"type":20},"2026-10-14",{"date":92,"type":20},"2032-04-16",{"name":94,"class":70},"SWOG Cancer Research Network",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100629542","early-phase-1-efficacy-and-safety-of-cd7-car-t-in-newly-diagnosed-high-risk-t-lblall-100629542","NCT07476027","Efficacy and Safety of CD7 CAR-T in Newly Diagnosed High-Risk T-LBL\u002FALL","Efficacy and Safety of CD7 CAR-T Cell in Newly Diagnosed High-Risk T-LBL\u002FALL","Inclusion Criteria:\n\n* Patients aged ≤18 years with newly diagnosed T-LBL\u002FALL.\n* Have completed induction chemotherapy and achieved CR1, with bone marrow MRD \\\u003C 0.01%.\n* High\u002Fvery high-risk or poor induction response patients.\n* High risk of future relapse, and recommended by multidisciplinary team (MDT) evaluation for prospective lymphocyte collection and preparation.\n* Peripheral blood absolute lymphocyte count (ALC) ≥ 0.5×10⁹\u002FL, and good general condition (ECOG score 0-1 or Lansky\u002FKarnofsky score ≥ 80).\n* Legal guardian agrees to provide written informed consent.\n\nInfusion Criteria:\n\n* Essential normal function of major organs.\n* Left ventricular ejection fraction (LVEF) ≥ 45%.\n* Serum creatinine ≤ 1.5 × upper limit of normal (ULN) for age.\n* Serum total bilirubin, ALT\u002FAST ≤ 3 × ULN (unless clearly related to leukemic infiltration).\n* No active, uncontrolled severe infection.\n\nExclusion Criteria:\n\n* Severe cardiac or pulmonary insufficiency, which the investigator deems inappropriate for enrollment.\n* Complicated with other progressive malignant tumors.\n* Presence of active and\u002For uncontrolled infections that have not been effectively managed.\n* Complicated with severe autoimmune diseases or congenital immunodeficiency.\n* Active hepatitis \\[positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb), with HBV DNA copy number greater than the upper limit of normal at the study center; positive for anti-HCV, with HCV-RNA copy number greater than the upper limit of normal at the study center\\].\n* Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), syphilis infection.).\n* A history of severe hypersensitivity to biological products (including antibiotics).\n* Patients who have undergone allogeneic hematopoietic stem cell transplantation and still suffer from acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents.\n* Patients with other severe physical or mental diseases or abnormal laboratory test results that may increase the risk of study participation or interfere with study outcomes, as well as those who are deemed unsuitable for participation in this study by the investigator.",{"count":103,"type":20},10,[105],"EARLY_PHASE1","This study is an open, single-center, prospective clinical trial, with newly diagnosed high-risk T-LBL\u002FALL patients as the subjects. It plans to enroll 10 subjects. All patients will undergo lymphocyte collection during the CR1 remission period, followed by the preparation and reinfusion of CD7 CAR-T cells. Adverse reactions will be followed up and observed, and relevant data on treatment efficacy will be collected to evaluate the safety, efficacy, and cell metabolic kinetics characteristics of CAR-T cell therapy for the patients.",[59,27],"2026-03-12",{"date":110,"type":32},"2026-03-17",{"date":112,"type":20},"2026-03-15",{"date":114,"type":20},"2029-06-27",{"name":116,"class":39},"Institute of Hematology & Blood Diseases Hospital, China",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":40},"100095334","phase-2-combination-chemotherapy-and-nelarabine-in-treating-patients-with-t-cell-acute-lymphoblastic-leukemia-or-lymphoblastic-lymphoma-100095334","NCT00501826","Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma","Inclusion Criteria:\n\n* Previously untreated T cell ALL including T cell lymphoblastic lymphoma; failure to one induction course of chemotherapy are eligible; patients in CR after =\\\u003C 2 courses are also eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3\n* Serum bilirubin less than or equal to 2.0 mg\u002FdL unless considered due to involvement by tumor when an upper limit of 5.0 mg\u002FdL is acceptable\n* Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) less than or equal to 4 x upper limit of normal (ULN)\n* Serum creatinine less than or equal to 2.0 mg\u002FdL unless considered due to involvement by tumor when an upper limit of 2.5 mg\u002FdL is acceptable\n\nExclusion Criteria:\n\n* Pregnant or nursing women",{"count":125,"type":20},160,[23],"This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.",[27,59],"2026-01-05",{"date":131,"type":32},"2026-01-07",{"date":133,"type":32},"2007-07-11",{"date":135,"type":20},"2026-10-31",{"name":137,"class":39},"M.D. Anderson Cancer Center",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":152,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":164,"locationsCount":40},"100594609","phase-2-use-of-a-new-medicine-daratumumab-to-treat-left-over-cancer-in-a-blood-cancer-called-t-acute-lymphoblastic-leukemia-100594609","NCT07021677","Use of a New Medicine \"Daratumumab\" to Treat Left-over Cancer in a Blood Cancer Called \"T Acute Lymphoblastic Leukemia\"","Daratumumab for Minimal Residual Disease Eradication in T-Acute Lymphoblastic Leukemia - A Phase 2 Study","DARA_T_ALL","Inclusion Criteria:\n\n1. Adults ≥18 - ≤65 years of age\n2. Baseline diagnosis of T-ALL, including ETP-ALL\n3. MRD positive (≥0.01%) disease (by flow-cytometry) assessed on BM after two phases of induction chemotherapy in CR-1\n4. CD38 positive\n5. Eastern cooperative oncology group (ECOG) performance status ≤2\n6. Acceptable liver functions, as specified below:\n\n   Total bilirubin \\\u003C2 times upper limit of normal (ULN); Aspartate transaminase (AST;SGOT), alanine transaminase (ALT;SGPT) \\\u003C3 ULN\n7. Subject ready to sign an informed consent form\n8. Patients with baseline CSF cytology positive, but who have cleared CSF by either modality (cytology or flow cytometry)\n\nExclusion Criteria:\n\n1. T-LBL (T-lymphoblastic lymphoma) without BM involvement\n2. Patients with persistently positive CSF cytology after two phases of induction or baseline testicular involvement\n3. Patients with symptomatic obstructive airway disease, as per assessing clinician\n4. Presence of an active systemic infection, as per assessing clinician\n5. New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction \\\u003C40%\n6. Human immunodeficiency virus (HIV) positive.\n7. Pregnant or breastfeeding female\n8. HBsAg positive or HBV-DNA positivity","65 Years",{"count":148,"type":20},18,[23],"T-ALL (T-acute lymphoblastic leukemia) is an aggressive blood cancer, wherein patients who are MRD positive after two courses of induction chemotherapy have poor outcomes. This goal of this study is to determine if Daratumumab can make such T-ALL patients MRD negative.\n\nThe main questions this study aims to answer are -\n\n1. Whether MRD Positive T-ALL patients can become MRD negative after two doses of daratumumab?\n2. Whether MRD Positive T-ALL patients can become MRD negative after four doses of daratumumab?\n3. Whether addition of daratumumab can affect the risk of progression or death at 1-year?\n4. Whether daratumumab is safe to use?\n\nNewly diagnosed patients of T-ALL who are MRD positive after two courses of induction chemotherapy will be eligible to receive daratumumab. These patients will receive two doses of weekly intravenous daratumumab at standard dose (16mg\u002Fkg), and will undergo repeat evaluation of MRD from bone marrow one week after the second dose of daratumumab. Patients who become MRD negative will continue chemotherapy as per institutional policy. Those who remain MRD positive will be eligible to receive two additional doses, and will undergo another bone marrow MRD testing one week after the fourth dose. Irrespective of the results after the fourth dose, patients will be continued on chemotherapy as per institutional policy.",[27],[153,154,155,156,157],"daratumumab","T-Acute lymphoblastic leukemia","minimal residual disease","MRD","Post induction MRD","2025-06-13",{"date":160,"type":32},"2025-06-15",{"date":162,"type":32},"2023-08-28",{"date":65,"type":20},{"name":165,"class":39},"Tata Memorial Centre",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":173,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":182,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":40},"100593900","phase-2-venetoclax--azacytidine-for-newly-diagnosed-etp-like-all-and-t-all-with-myeloid-mutations-100593900","NCT07012447","Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations","Evaluating the Efficacy of Venetoclax Combined With Azacitidine Induction Therapy of Early T-cell Precursor-like Acute Lymphoblastic Leukemia and T-ALL With Myeloid Mutations","Inclusion Criteria:\n\n1. No gender restrictions\n2. Age ≥ 14 years\n3. Confirmed diagnosis of one of the following:\n\n   ETP-like leukemia (CD7⁺, CD1a-, CD8-, with CD5 expression stratified as ETP-ALL ≤75% or Near-ETP-ALL \\>75%) T-cell acute lymphoblastic leukemia (T-ALL) with myeloid mutations (including FLT3, DNMT3A, STAG2, IDH1\u002F2, RUNX1, EZH2, WT1, ASXL1\u002F2, SF3B1, TET2, BCOR, BCORL1, and MLL-PTD) T\u002Fmyeloid mixed phenotype acute leukemia (T\u002FMy-MPAL) (with concurrent T-lineage and myeloid markers, e.g., cCD3⁺\u002FmCD3⁺, CD7⁺, MPO⁺)\n4. Newly diagnosed patients without prior induction therapy Limited prior therapy allowed: hydroxyurea, dexamethasone, or low-dose cytarabine\u002Fvenetoclax (cumulative dose \\\u003C0.5g), and leukocytapheresis\n5. Expected survival time ≥ 3 months\n6. Liver function: total bilirubin ≤ 2× ULN; ALT\u002FAST ≤ 3× ULN (or ≤ 5× ULN if liver infiltration by leukemia is present) ; Renal function: endogenous creatinine clearance ≥ 30 ml\u002Fmin; Cardiac function: left ventricular ejection fraction \\> 45%\n7. Demonstrated capacity to understand the study and willingness to provide informed consent\n\nExclusion Criteria:\n\n1. Presence of recurrent genetic abnormalities such as t(8;21), t(15;17), inv(16)\u002Ft(16;16) leukemia\n2. Prior hypersensitivity to study drugs or compounds of similar chemical structure\n3. Active uncontrolled infections as determined by the investigator\n4. Active bleeding\n5. Recent history (within 1 year) of thrombosis, embolism, or cerebral hemorrhage\n6. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential\n7. Drug addiction or chronic alcoholism that could interfere with trial evaluation\n8. Psychiatric disorders or other conditions that would prevent obtaining informed consent or compliance with trial requirements\n9. Any condition deemed unsuitable for trial participation by the investigator","14 Years",{"count":175,"type":20},32,[23],"The goal of this clinical trial is to evaluate the efficacy and safety of venetoclax combined with azacitidine in treating newly diagnosed early T-cell precursor (ETP)-like acute lymphoblastic leukemia (ALL), T-ALL with myeloid mutations, or T\u002Fmyeloid mixed-phenotype acute leukemia (T\u002FMy-MPAL).\n\nParticipant population: Patients aged ≥14 years diagnosed with ETP-like leukemia, T-ALL with myeloid mutations, or T\u002FMy-MPAL, regardless of sex\u002Fgender.\n\nThe main question it aims to answer: Does venetoclax plus azacitidine achieve a significantly higher overall response rate (ORR: CR + CRi) compared to historical controls (54% vs. 90%) after two induction cycles?\n\nComparison group: Researchers will compare ORR outcomes to historical data from conventional chemotherapy regimens to assess treatment superiority.\n\nParticipants will:\n\n* Receive two 28-day cycles of venetoclax (oral, 100 mg D1, 200 mg D2, 400 mg D3-28) and azacitidine (75 mg\u002Fm²\u002Fday SC, D1-7).\n* Undergo serial bone marrow biopsies, blood tests, and imaging (e.g., PET-CT) for response assessment.\n* Follow dose adjustment protocols for toxicity management (e.g., neutropenia, thrombocytopenia).",[179,180,181],"Early T Acute Lymphoblastic Leukemia","T-Acute Lymphoblastic Leukemia","Mixed Phenotype Acute Leukemia, T\u002FMyeloid, Nos",[183,184,185],"Adverse risk","newly diagnosed","induction therapy","2025-06-02",{"date":188,"type":32},"2025-06-10",{"date":190,"type":32},"2025-04-01",{"date":192,"type":20},"2028-05-01",{"name":194,"class":39},"yuejun Liu",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":40},"100564759","early-phase-1-targeting-cd5-car-t-cells-in-the-treatment-of-rr-cd5-t-all-100564759","NCT06633354","Targeting CD5 CAR-T Cells in the Treatment of r\u002Fr CD5+ T-ALL","A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r\u002Fr CD5+ T-ALL","Inclusion Criteria:\n\n* 1\\. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;\n* 2\\. Consistent with r\u002Fr CD5+T-ALL diagnosis, including any of the following conditions:\n\n  1. No CR after standard chemotherapy;\n  2. The first induction reaches CR, but CR ≤ 12 months;\n  3. Patients with r\u002Fr CD5+T-ALL have not responded to the first or multiple remedial treatments;\n\n  c.Multiple recurrences.\n* 3\\. CD5 expression rate was \\>90%;\n* 4\\. Number of blasts in the bone marrow (protolychic + larvae) \\>5% (morphology) and\u002For \\>1% (flow cytometry);\n* 5\\. Total bilirubin ≤51 (mol\u002FL), Alanine aminotransferase (ALT)\u002FAspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol\u002FL);\n* 6\\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;\n* 7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);\n* 8.Estimated life expectancy of minimum of 12 weeks;\n* 9.ECOG 0-2;\n* 10.Pregnant\u002Flactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;\n* 11\\. Those who voluntarily participated in this trial and provided informed consent;\n\nExclusion Criteria:\n\n* 1.Patients with the history of epilepsy or other CNS disease;\n* 2\\. Patients with prolonged QT interval time or severe heart disease;\n* 3\\. Active infection of hepatitis B virus, C virus or hepatitis E virus;\n* 4\\. Active infection with no cure;\n* 5\\. Before using any gene therapy products;\n* 6\\. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:\n\n  1. treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone \\\u003C 10 mg\u002Fd or an equivalent dose of the drug);\n  2. received within 72 hours of small molecule targeted therapy;\n  3. 2 weeks received systemic chemotherapy except (pretreatment);\n  4. four weeks received radiotherapy;\n* 7\\. The proiferation rate is less than 5 times response to CD3\u002FCD28 co-stimulation signal;\n* 8\\. Any unsuitable to participate in this trial judged by the investigator;\n* 9\\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.",{"count":19,"type":20},[105],"A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r\u002Fr CD5+ T-ALL",[180],[207],"CD5 CAR-T","2024-10-08",{"date":210,"type":32},"2024-10-09",{"date":212,"type":20},"2024-10-20",{"date":214,"type":20},"2027-10-20",{"name":216,"class":39},"Zhejiang University"]