[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoblastic-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,42,69,90,112,135,172,202,224,251,283,311],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100614749","phase-1-a-phase-ib-trial-of-subcutaneous-blinatumomab-in-combination-with-revumenib-for-patients-with-kmt2a-rearranged-acute-lymphoblastic-leukemia-100614749",false,"NCT07283640","A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia","Eligibility Criteria\n\n• The following groups of participants will be eligible:\n\n* Participants \\> 18 years of age with relapsed and\u002For refractory (defined as \\>5% blasts in the peripheral blood or bone marrow) KMT2A-r B-cell ALL or\n* Participants \\>18 years of age with persistent measurable residual disease by flow cytometry or next generation sequencing KMT2A-r B-cell ALL or\n* Newly diagnosed participants with KMT2A-r B-cell ALL \\> 60 years old or unfit for intensive chemotherapy\n\nUnfit for intensive chemotherapy defined as:\n\n* ECOG \\>2\n* Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction \\\u003C50%, or chronic stable angina)\n* Severe pulmonary disorder (e.g., DLCO \\\u003C65% or FEV1 \\\u003C65%)\n* Creatinine clearance \\\u003C45 ml\u002Fmin\n* Hepatic disorder with total bilirubin 1.5 x upper limit of normal\n* Performance status \\\u003C2 per ECOG scale (for R\u002FR participants)\n* Adequate liver function as defined by the following criteria:\n\n  * Total serum bilirubin \\\u003C1.5 x upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 x ULN\n* Adequate pancreatic function as define by serum lipase and amylase \\\u003C 1.5 x ULN\n* For females of childbearing potential, a negative pregnancy test must be documented (negative serum pregnancy test performed at the time of screening and negative serum or urine pregnancy test prior to the first dose of study drug)\n* The effects of blinatumomab and revumenib on the developing human fetus are unknown. For this reason and because menin inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of blinatumomab and revumenib administration. Males must also agree to refrain from sperm donation during this time period.\n* Adequate cardiac function as assessed clinically by history and physical examination with an ejection fraction of \\>50% by echocardiogram or multigated acquisition (MUGA) scan\n* White blood cell (WBC) count below 25,000\u002FuL at the time of enrollment. Participants may receive cytoreduction with dexamethasone and\u002For cyclophosphamide for cytoreduction\n* Estimated glomerular filtration rate (GFR) based on local institutional practice for age appropriate determination by Cockcroft Gault formular for adults, with a GFR\\>60 ml\u002Fmin\u002F1.73m2\n* For participants having previously received stem cell transplant, at least 60 days must have elapsed, and for prior donor lymphocyte infusion, at least 4 weeks must have elapsed\n* For participants having previously received immunotherapy, at least 60 days must have passed\n* Weight of at least 40 kg\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Active serious infection not controlled by oral or IV antibiotics\n* Active secondary malignancy other than skin cancer (basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year\n* Participants with psychiatric illness that would limit compliance with study requirements\n* Untreated CNS disease. Participants with controlled CNS disease may be included (as defined by being asymptomatic and having CNS cleared of leukemic involvement)\n* Detectable HIV viral load within the previous 6 months. Participants with a known history of HIV must have viral load testing prior to study enrollment.\n* Any of the following within 6 months prior to study entry: myocardial infarction, congestive heart failure New York Heart Association Classification Class \\> II, life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack\n* QTc using Friderica's correction (QTcF) \\>450 msec\n* Personal of family history of long QT syndrome\n* Cirrhosis with a Child Pugh score of B or C\n* Participants with active hepatitis B (defined as Hepatitis B surface antigen with detectable Hepatitis B virus DNA by PCR) or hepatitis C infection (defined as presence of detectable Hepatitis C virus RNA by PCR)","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed\u002Frefractory Ph-negative ALL with a KMT2A rearrangement.",[25,26,27,28],"Blinatumomab","Revumenib","Lymphoblastic Leukemia","KMT2A-rearranged","NOT_YET_RECRUITING","2026-06-22",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":19},"2026-11-18",{"date":37,"type":19},"2031-08-31",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":41},"100419913","phase-2-study-of-chemotherapy-free-induction-regimen-for-ph-acute-lymphoblastic-leukemia-with-inotuzumab-ozogamicin-ino-100419913","NCT04747912","Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)","A Phase II Study of a Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia (ALL) Incorporating Inotuzumab Ozogamicin (InO)","Inclusion Criteria:\n\n1. Must be a newly diagnosed and untreated patient with Ph+ B-cell Acute Lymphoblastic Leukemia and CD22 expression on ≥20% of blasts.\n2. 18 years old or older.\n3. Bone marrow involvement with ≥20% lymphoblasts and demonstration of BCR-ABL1 via fluorescence in situ hybridization (FISH) studies or PCR-based testing. Patients with \\>1000\u002Fmm3 lymphoblasts in the peripheral blood that cannot undergo bone marrow biopsy and aspiration due to clinical condition are also eligible.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Adequate organ function as confirmed by clinical\u002Fmedical record.\n6. Patients must be at least 2 weeks from major surgery, radiation therapy, or participation in other investigational trials, and must have recovered from clinically significant toxicities related to these prior treatments.\n7. Patients must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee\u002FInstitutional Review Board prior to starting any screening or study-specific procedures.\n8. Females of childbearing potential will use effective contraception during treatment with InO and for at least 8 months after the last dose. Males with female partners of reproductive potential will use effective contraception during treatment with Inotuzumab Ozogamicin and for at least 5 months after the last dose. A patient is of childbearing potential if, in the opinion of the treating investigator, he\u002Fshe is biologically capable of having children and is sexually active. Female patients who are not of childbearing potential (ie, meet at least one of the following criteria):\n\n   a. Have undergone hysterectomy or bilateral oophorectomy; or have medically confirmed ovarian failure; or are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause).\n9. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Isolated extramedullary disease.\n2. Burkitt's or mixed-lineage leukemia.\n3. Active central nervous system (CNS) leukemia.\n4. Any prior therapy for ALL except for limited treatment (≤ 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal therapy. Patients who are being treated with chronic steroids for other reasons (eg, asthma, autoimmune disorders) are eligible.\n5. Current or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen and anti-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV). HIV testing may need to be performed in accordance with local regulations or local practice. Patients with HIV but an undetectable viral load are eligible for enrollment\n6. Major surgery within ≤ 2 weeks before randomization.\n7. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function or unstable pulmonary condition.\n8. Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been definitely treated with radiation or surgery. Patients with previous malignancies are eligible provided that they have been disease free for ≥2 years or are not currently requiring treatment.\n9. Uncontrolled cardiac disease.\n10. QTcF \\> 500 msec (based on the average of 3 consecutive ECGs).\n11. History of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.\n12. History of hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).\n13. Evidence of uncontrolled current serious active infection including sepsis, bacteremia, fungemia, or patients with a recent history (within 4 months) of deep tissue infections such as fasciitis or osteomyelitis.\n14. Medications known to predispose to Torsades de Pointes are prohibited throughout the treatment period of the study.\n15. Pregnant females; breastfeeding females; males with female partners of reproductive potential and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for a minimum of 5 months after the last dose of investigational product if male and 8 months after the last dose of investigational product if female.\n16. Patients who are investigational site staff members or relatives of those site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.\n17. Participation in other investigational studies during active treatment phase.\n18. Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Study Lead Principal Investigator, would make the patient inappropriate for entry into this study.",{"count":50,"type":19},25,[52],"PHASE2","This research study will add an anti-cancer drug (called inotuzumab ozogamicin also known as \"InO\") to treatment for participants with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Doctors leading this study hope to learn if adding InO to standard induction treatment for Ph+ ALL will lead to quicker, complete molecular remission (where the disease is not detectable even with very sensitive testing techniques). The purpose of this research is to gather information regarding the effectiveness of InO in newly-diagnosed Ph+ ALL patients that have not yet received treatment.",[27,55,56],"Acute Lymphoblastic Leukemia","ph+ Acute Lymphoblastic Leukemia",[58,55,56],"leukemia","RECRUITING","2026-06-03",{"date":62,"type":33},"2026-06-05",{"date":64,"type":33},"2021-03-02",{"date":66,"type":19},"2028-03-01",{"name":68,"class":40},"University of Chicago",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":20,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100504467","phase-1-tini-2-total-therapy-for-infants-with-acute-lymphoblastic-leukemia-ii-100504467","NCT05848687","TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II","Inclusion Criteria:\n\n* Patient is ≤ 365 days of age at the time of diagnosis.\n* Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia. Subjects with bilineage or biphenotypic acute leukemia are eligible provided they express CD19. Patients with CD19 positive mature B-cell ALL who carry a KMT2A rearrangement are eligible.\n* Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, cytarabine for 72 hours or less, one dose of vincristine, and one dose of intrathecal chemotherapy.\n* Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.\n\nExclusion Criteria:\n\n* Patients with prior therapy, other than therapy specified in inclusion criteria.\n* Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients with acute myelogenous (AML) or T-cell ALL.\n* Patients with Down syndrome.\n* Inability or unwillingness of legal guardian\u002Frepresentative to give written informed consent","1 Year",{"count":77,"type":19},90,[22,52],"The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.",[27],"2026-05-31",{"date":60,"type":33},{"date":84,"type":33},"2023-11-03",{"date":86,"type":19},"2033-12",{"name":88,"class":40},"Tanja Andrea Gruber",24,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":20,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":41},"100606696","phase-2-phase-ii-study-of-the-combination-of-subcutaneous-blinatumomab-and-olverembatinib-in-patients-with-philadelphia-chromosome-ph-positive-andor-bcrabl1-positive-acute-lymphoblastic-leukemia-all-100606696","NCT07178912","Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and\u002For BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)","Eligibility Criteria\n\n* Diagnosis of one of the following:\n\n  o Participants ≥18 years of age with newly diagnosed or relapsed\u002Frefractory Ph-positive and\u002For BCR::ABL1-positive ALL (includes Participants initiated on first course of therapy before cytogenetics known) or with lymphoid accelerated or blast phase CML. Participants with newly diagnosed disease could have received one or two courses of chemotherapy with or without other TKIs and still eligible (Participants with lymphoid accelerated or blast phase CML will be evaluated separately).\n* Performance status ≤2 (ECOG Scale).\n* Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\n  * Total serum bilirubin \\\u003C2 x upper limit of normal (ULN), unless due to Gilbert's syndrome\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 x ULN.\n* Adequate pancreatic function as defined by serum lipase and amylase \\\u003C1.5 x ULN.\n* For females of childbearing potential, a negative urine pregnancy test must be documented.\n* Female Participants who:\n\n  * Are postmenopausal for at least 1 year before the screening visit, OR\n  * Are surgically sterile, OR\n  * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.\n* Male Participants, even if surgically sterilized (i.e., status post-vasectomy), who:\n\n  * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n  * Agree to completely abstain from heterosexual intercourse.\n* Adequate cardiac function as assessed clinically by history and physical examination.\n* Signed informed consent.\n\nExclusion Criteria\n\n* Active serious infection not controlled by oral or IV antibiotics.\n* Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nActive grade III-V cardiac failure as defined by the New York Heart Association criteria.\n\n* Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n  * Myocardial infarction, stroke, or revascularization within 3 months\n  * Unstable angina or transient ischemic attack\n  * Congestive heart failure prior to enrollment, or left ventricular ejection fraction less than lower limit of normal per local institutional standards prior to enrollment\n  * Diagnosed or suspected congenital long QT syndrome\n  * Clinically significant atrial or ventricular arrhythmias (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician\n  * Prolonged QTc interval on pre-entry electrocardiogram (\\>470 msec) unless corrected after electrolyte replacement or approved by cardiologist\n  * Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated thrombosis will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility\n  * Uncontrolled hypertension (diastolic blood pressure \\>90 mmHg, systolic \\>140 mmHg). Participants with hypertension should be under treatment on study entry for blood pressure control.\n* History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Participants with active CNS leukemia will not be excluded.\n* Current autoimmune disease or history of autoimmune disease with potential CNS involvement.\n* Treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days before study entry, unless full recovery from side effects has occurred or Participant has rapidly progressive disease judged to be life-threatening by the investigator.\n* Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n* History of significant bleeding disorder unrelated to cancer, including:\n\n  * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)\n  * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).\n* Participants with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.",{"count":97,"type":19},60,[52],"To find out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.",[101,25,102,27,103],"Phase II Clinical Trial","Olverembatinib","Philadelphia Chromosome Positive","2026-04-29",{"date":106,"type":33},"2026-05-05",{"date":108,"type":19},"2026-08-27",{"date":110,"type":19},"2033-09-30",{"name":39,"class":40},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":20,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100532001","phase-1-a-study-to-investigate-lp-118-ponatinib-vincristine-and-dexamethasone-in-relapsedrefractory-acute-lymphoblastic-leukemia-all-or-lymphoblastic-lymphoma-lbl-100532001","NCT06207123","A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)","A Phase I\u002FII Study to Investigate the Combination of LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed\u002FRefractory T-ALL\u002FLBL","Inclusion Criteria:\n\n1. Relapsed or refractory patients with T-lineage acute lymphoblastic leukemia or T-lymphoblastic lymphoma\n2. 18 years old or older\n3. Bone marrow or peripheral blood involvement with ≥5% lymphoblasts or measurable residual disease with \\>10-4 level detected by multiparameter flow cytometry or next-generation sequencing (NGS)-based measurable residual disease (ClonoSEQ, Adaptive Technologies). Patients with isolated extramedullary disease that is measurable by computed tomography (CT) scan are also eligible.\n4. Eastern Cooperative Oncology Group performance status 0-2.\n5. Adequate organ function as defined by all of the following:\n\n   1. Creatinine clearance ≥50 mL\u002Fmin, determined by the Cockroft-Gault formula, or measured by a 24-hour urine collection.\n   2. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN) and bilirubin ≤1.5 x ULN (unless considered due to Gilbert's syndrome or of non-hepatic origin i.e,, leukemic involvement). For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.\n6. Participants must be at least 2 weeks from major surgery or radiation therapy. A wash-out period of 4 half-lives is required for patients who participated in other investigational trials. These patients must have recovered from clinically significant toxicities related to these prior treatments.\n7. Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.\n8. Females of childbearing potential will use effective contraception during protocol treatment and for at least 8 months after the last dose. Males with female partners of reproductive potential will use effective contraception during protocol treatment and for at least 5 months after the last dose. A patient is of childbearing potential if, in the opinion of the treating investigator, he\u002Fshe is biologically capable of having children and is sexually active. Female patients who are not of childbearing potential (ie, meet at least one of the following criteria):\n\n   a. Have undergone hysterectomy or bilateral oophorectomy; or have medically confirmed ovarian failure; or are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause).\n9. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Active central nervous system (CNS) leukemia\n2. Active or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen and anti-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV). Patients with HIV but an undetectable viral load are eligible for enrollment.\n3. Major surgery within \\\u003C2 weeks before randomization.\n4. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function or unstable pulmonary condition.\n5. Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been definitely treated with radiation or surgery. Patients with previous malignancies are eligible provided that they have been disease free for ≥2 years or are not currently requiring treatment.\n6. Uncontrolled cardiac disease.\n7. Pregnant females; breastfeeding females; males with female partners of reproductive potential and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for a minimum of 5 months after the last dose of investigational product if male and 8 months after the last dose of investigational product if female.\n8. Participation in other investigational studies during active treatment phase.\n9. Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the treating physician, would make the patient inappropriate for entry into this study.",{"count":120,"type":19},15,[22,52],"The purpose of this study is to learn more about LP-118 (an experimental drug) and its side effects and decide on acceptable doses. The purpose of this study is to determine if LP-118 can be given safely with another medicine called ponatinib, that is FDA-approved for the treatment of acute lymphoblastic leukemia.",[124,27,125],"Acute Leukemia","Lymphoblastic Lymphoma","2026-03-16",{"date":128,"type":33},"2026-03-18",{"date":130,"type":33},"2024-09-13",{"date":132,"type":19},"2026-12-01",{"name":68,"class":40},2,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":15,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":20,"phases":147,"briefSummary":148,"conditions":149,"keywords":154,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100454196","phase-2-exercise-training-and-nr-supplementation-trial-to-improve-fitness-in-aya-hct-survivors-100454196","NCT05194397","Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors","Intensive Tailored Exercise Training With NAD+ Precursor Supplementation to Improve Muscle Mass and Fitness in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors","IAMFIT","Inclusion Criteria:\n\n1. Males and females, ages 10-30 years at enrollment\n2. Able to understand and speak English\n3. Diagnosis of leukemia (myeloid, lymphoid), aplastic anemia, bone marrow failure syndrome, or myelodysplastic syndrome requiring allogeneic HCT\n4. 6-48 months from allogeneic HCT\n5. Females must have a negative urine\u002Fserum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.\n6. Subject's informed consent or parental\u002Fguardian permission (informed consent) and if appropriate, child assent\n7. Minimum weight of 24 kg\n\nExclusion Criteria:\n\n1. Known sensitivity to NR\n2. Concurrent use of any medications, including statins, likely to increase risk of NR toxicity\n3. Active malignancy, investigational agent(s) within 4 wks, or supraphysiological glucocorticoids at the baseline visit\n4. Currently meeting public health exercise guidelines\n5. Use of NAD+ precursors (supra-physiologic) within 4 weeks\n6. Hemoglobin \\\u003C 10 g\u002FdL\n7. Platelets \\\u003C 50K\n8. Diabetes Mellitus requiring insulin or insulin secretagogue\n9. HbA1C ≥ 8% or fasting glucose \\> 125 mg\u002FdL; However if the participant is diabetic, both fasting glucose level and HbA1C must meet the criteria to be deemed eligible.\n10. Kidney disease (eGFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2)\n11. Liver disease Alanine aminotransferase (ALT)\u002FAspartate aminotransferase (AST) (ALT\u002FAST \\> 3 x ULN)\n12. Limitations in physical function preventing exercise testing\u002Ftraining\n13. Unstable angina or history of acute myocardial infarction (\\\u003C5 days of planned study procedures)\n14. Recurrent syncope\n15. Symptomatic severe aortic stenosis\n16. Uncontrolled arrhythmia causing symptoms\n17. Pulmonary embolus \\\u003C3 months of study procedures\n18. Thrombosis of lower extremities\n19. Symptomatic moderate or severe persistent asthma based on Forced Expiratory Volume (FEV) from pre-HCT pulmonary function testing\n20. Room air desaturation at rest ≤85%\n21. Females: Pregnant or planning pregnancy\n22. Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g. infection, renal failure, thyrotoxicosis, \\>moderate Graft versus host disease (GVHD) resulting in physical or functional impairment)\n23. Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.\n24. For MRI procedure: Contraindications to MRI. Individuals will be screened to ensure they can safely complete the MRI. \\*participants who cannot complete the MRI will not be excluded from participation in the remainder of the study procedures if they meet those inclusion and exclusion criteria.\n25. Current weight precludes safe completion of study procedures","10 Years","30 Years",{"count":146,"type":19},80,[52],"This will be a randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise on skeletal muscle quality and VO2max in AYA HCT survivors.\n\nThe primary outcome is the change in muscle strength (isometric knee extension) from baseline to 16 weeks. Key secondary outcomes are the change in muscle strength (ankle plantarflexion) from baseline to 16 weeks, the change in grip strength from baseline to 16 weeks, the change in lower extremity muscle mass from baseline to 16 weeks, the change in muscle OXPHOS capacity from baseline to 16 weeks, and the change in aerobic capacity (VO2 max) from baseline to 16 weeks.",[27,150,151,152,153],"Cancer Survivors","Aplastic Anemia","Myelodysplastic Syndromes","Myeloid Leukemia",[155,156,157,158,159,160,150,161],"Sarcopenia","NAD+","Exercise Intervention","OXPHOS Capacity","VO2 Max","Adolescent young adults","Hematopoietic Stem Cell Transplantation (HCT)","2025-12-02",{"date":164,"type":33},"2025-12-04",{"date":166,"type":33},"2023-02-23",{"date":168,"type":19},"2026-06-30",{"name":170,"class":40},"Children's Hospital of Philadelphia",3,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":15,"minAge":180,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":20,"phases":183,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":41},"100589996","intravenous-autologous-cd19-car-t-cells-for-r-r-mm-b-all-and-b-cell-lymphoma-100589996","NCT06961669","Intravenous Autologous CD19 CAR-T Cells for R\u002F R MM, B-ALL, and B-Cell Lymphoma","An Early Exploratory Clinical Study of Enhanced Autologous CAR-T Cell Injection (ECAR01) Targeting CD19 and BCMA in Patients With Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma","ECAR01","Inclusion Criteria:\n\n1. The patient or his\u002Fher guardian is fully informed and agrees to participate in this clinical study and signs the informed consent form;\n2. At the time of signing the informed consent form, be over 3 years of age, regardless of gender;\n3. Patients with a confirmed diagnosis of acute B-cell leukemia\u002FB-cell lymphoma\u002Fmultiple myeloma who meet one of the following criteria:\n\n   1. B diffuse large B-cell lymphoma (DLBCL), germinal center, or activated B-cell type; Primary cutaneous DLBCL; Primary mediastinal (thymic) large B-cell lymphoma; ALK anaplastic large B-cell lymphoma; High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangement (i.e., \"double or triple hit\"); High-grade B-cell lymphoma; T-cell-rich B-cell lymphoma; transformed follicular lymphoma; or any aggressive B-cell lymphoma caused by indolent lymphoma; follicular lymphoma; mantle cell lymphoma; Patients with large cell transformation (Richter's Transformation) with CLL who have not achieved remission or have progressed after achieving remission after at least 1 prior line of therapy.\n   2. Patients diagnosed with acute B-cell leukemia: Patients who have achieved relapse after achieving remission after prior chemotherapy; or patients who have failed to achieve remission (\\\u003C5% bone marrow blasts or persistent extramedullary or central nervous system disease) after 2 prior cycles of induction chemotherapy, or who still maintain MRD.\n   3. Multiple Myeloma: Patients with confirmed diagnosis of multiple myeloma and patients with relapsed or refractory multiple myeloma according to IMWG 2016 diagnostic criteria.\n4. For patients with B-cell lymphoma, according to the recommendations for initial evaluation, staging, and response evaluation of Hodgkin and non-Hodgkin lymphoma (2014 edition), at least one measurable lesion in the baseline period, i.e., lymph node lesions with a length diameter of \\> 15 mm, or an extranodal lesion with a length diameter of \\> 10 mm according to PETCT or CT imaging;\n5. For patients with B-ALL, the proportion of bone marrow primitive and naïve lymphocytes in the screening period ≥5%;\n6. CD19 expression of tumor cells confirmed by flow cytometry or immunohistochemistry: the proportion of CD19 cells detected by peripheral blood flow cytometry in patients with B-ALL was ≥30%, and the proportion of CD19 cells in patients with B-cell lymphoma was positive by immunohistochemistry;\n7. Adequate function of vital organs: liver function satisfies ALT≤3×ULN, AST≤3×ULN; serum creatinine≤140μmol\u002FL; Total bilirubin ≤ 2× ULN, and total bilirubin ≤ 3.0× ULN for patients with Gilbert syndrome; Haemodynamically stable and left ventricular ejection fraction (LVEF) ≥45% as determined by echocardiography or multichannel radionuclide angiography (MUGA); No active pulmonary infection, transcutaneous arterial oxygen saturation ≥92% in non-oxygen-based state;\n8. ECOG score: 0\\~2 points;\n9. As judged by the investigator, the patient has an expected survival of more than 3 months;\n10. Subjects of childbearing potential agree to use a reliable and effective method of contraception (excluding contraception during the safe period) for 2 years from the time of signing the informed consent form until receiving ECAR01 cell infusion.\n\nExclusion Criteria:\n\n1. Episodes of central nervous system disease or presence of pathological changes within 6 months prior to screening, including but not limited to: stroke, stroke, aneurysm, epilepsy, convulsions, aphasia, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or mental disorder;\n2. patients with B-ALL with confirmed diagnosis of isolated extramedullary recurrence;\n3. presence of malignancies other than acute B-cell leukemia\u002FB-cell lymphoma;\n4. Received the following anti-tumor therapies before cell collection: chemotherapy, targeted therapy, and other drug therapy within 14 days or at least 5 half-lives; Radiotherapy within 14 days;\n5. Vaccination, B-cell targeted therapy within 4 weeks prior to screening;\n6. Patient has systemic autoimmune disease or immunodeficiency;\n7. Grade 2\\~4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks prior to screening;\n8. Patients with relatively serious heart disease, such as angina, myocardial infarction, heart failure and arrhythmia;\n9. History of severe allergy to drugs used in clinical studies or raw and excipient materials of experimental drugs, such as cyclophosphamide, fludarabine, DMSO, etc.;\n10. Patient has active hepatitis B, or positive HCV antibody, or HIV antibody, or syphilis;\n11. Presence of active infection requiring intravenous antibiotics or hospitalization;\n12. Pregnant or lactating women;\n13. Other investigators believe that the subject is not suitable to participate in this clinical study because it will affect the safety and efficacy judgment of the subject, or for other reasons;","3 Years",{"count":182,"type":19},18,[184],"NA","This is an open label, single-site, dose-escalation study in up to 18 participants with Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART",[27,187],"Relapsed or Refractory Multiple Myeloma (RRMM)",[189,190,191],"B-cell lymphoma","Relapsed or Refractory Multiple Myeloma","Acute B-Cell Leukemia","2025-05-23",{"date":194,"type":33},"2025-05-29",{"date":196,"type":33},"2025-04-16",{"date":198,"type":19},"2028-08-31",{"name":200,"class":201},"Anhui Provincial Hospital","OTHER_GOV",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":15,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":20,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":41},"100573460","role-of-cbc-indices-in-acute-lymphoblastic-leukemia-patients-100573460","NCT06746571","Role of Cbc Indices in Acute Lymphoblastic Leukemia Patients","Inclusion Criteria:\n\n* patients newly diagnosed ALL\n\nExclusion Criteria:\n\n* others malignanices\n* ALL on therapy","5 Years","50 Years",{"count":211,"type":19},100,[184],"Role of cbc indices in acute lymphoblastic leukemia patients to explore the prognostic role of them in prediction the response to induction chemotherapy",[27],"2024-12-18",{"date":217,"type":33},"2024-12-24",{"date":219,"type":19},"2025-01-15",{"date":221,"type":19},"2026-01-15",{"name":223,"class":40},"Sohag University",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":4},"100529586","treatment-protocol-for-newky-diagnosed-adult-ph-positive-all-100529586","NCT06175702","Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL","Treatment Protocol for Newky Diagnosed Adult Ph-Chromosome Positive (BCR::ABL1) Acute Lymphoblastic Leukemia (LALPh2022)","LALPh2022","Inclusion Criteria:\n\n1. Patients with de novo avute lymphoblastic leukeima (ALL) Philadelphia chromosome-positive (BCR::ABL1) aged ≥18 years.\n2. CML blast crisis will be included. These patients will always receive transplantation, regardless of the molecular response or the genetic risk, following the recommendations of the SEHH CML group (Chronic Myleoid Leukemia Group from the Spanish Society of Hematology).\n3. Performance status 0-2; patients with performance status\\>2 attributable to ALL can be included.\n4. Patients without functional alteration of organs; liver function: total bilirubin, GOT, GPT, GGT and alkaline phosphatase less than 3 times the upper limit of the normal range of the laboratory; renal function: serum creatinine \\\u003C2 mg\u002Fdl or creatinine clearance \\> 30 ml\u002Fmin (except altered renal function attributable to ALL); normal heart function: EF ventricular \\> 50%; absence of severe chronic respiratory disease. In case that the alterations are secondary to the disease, it is at the discretion of the physician to determine if the patient can be included in the study.\n\nExclusion Criteria:\n\n1. Any other subtype of ALL.\n2. Patients with chronic liver disease.\n3. Patients with chronic respiratory failure.\n4. Renal failure not due to ALL.\n5. Lipase and amylase\\>1.5× ULN.\n6. Patients with positive HIV serology.\n7. Serious neurological alterations not due to ALL.\n8. Serious general condition condition (grades 3 or 4 on the WHO scale) not attributable to ALL.\n9. Pregnant or breastfeeding women.\n10. Impaired cardiac function (defined by an ejection fraction less than 50%), any clinically significant active or uncontrolled cardiovascular condition, uncontrolled hypertension, arrhythmias, ischemic cardiovascular or neurological events, deep vein thrombosis, pulmonary thromboembolism, history of acute pancreatitis in the year before diagnosis of ALL or history of chronic pancreatitis and triglycerides \\>450 mg\u002FdL.",{"count":233,"type":19},150,"OBSERVATIONAL","The goal of this prospective, multicenter, open observational study is to assess the efficacy and safety of the treatment for acute lymphoblastic leukemia Ph' positive adult patients with approved combinations of chemotherapy and tyrosine kinase inhibitor (TKI).\n\nEfficay refers to the rate of Complete Molecular Response (BCR::ABL1\u002FABL1 ratio 0.01%) in eah treatment arm. Safety refers to measurement of i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests), ii) incidence and degree of cytopenias and iii) incidence and degree of infections.\n\nLow-dose chemotherapy will be given together with the TKI imatinib to patients of all ages as induction to remission phase.\n\nConsolidation treatment will continue with low-dose chemotherapy with imatinib if the patient fullfills both criteria: to show a measurable residual disease (MRD) value lower than 0,01% at 3 month of therapy, and not showing IKZF1plus genetics Those patients have any of these 2 conditions will be considered high-risk patients and will recieve consolidation treatment intensification with low-dose chemotherapy plus ponatinib as TKI and allogeneic stem cell transplantation (allo SCT). The remaining patients (standard-risk) will receive maintenance chemotherapy together with imatinib or ponatinib and will not be submitted to alloSCT.",[27,237,238],"Philadelphia-Positive ALL","Adult ALL",[55,240,241],"Philadelphia (BCR::ABL1) positive","Adults","2023-12-15",{"date":244,"type":33},"2023-12-19",{"date":246,"type":19},"2023-12-25",{"date":248,"type":19},"2030-12-25",{"name":250,"class":40},"PETHEMA Foundation",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":15,"minAge":257,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":20,"phases":261,"briefSummary":262,"conditions":263,"keywords":269,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":134},"100489046","phase-2-cd19-directed-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsedrefractory-b-lineage-leukaemia--lymphoma---a-feasibility-protocol-100489046","NCT05648019","CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002FRefractory B-Lineage Leukaemia \u002F Lymphoma - A Feasibility Protocol","Inclusion Criteria:\n\n1. Eligible disease conditions:\n\n   1. Relapsed or refractory B-cell ALL (all must be satisfied)\n\n      * Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening.\n      * Relapsed or refractory or ineligible for HSCT\n      * For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry\n   2. Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.\n2. Age at screening:\n\n   1. \\\u003C 18 years (paediatric group); or\n   2. ≥ 18 years (adult group)\n3. Adequate organ functions:\n4. Life expectancy more than 12 weeks.\n5. Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening.\n6. Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site.\n\nExclusion Criteria:\n\nPatients with any of the following will be excluded:\n\n* B-ALL with isolated extramedullary disease relapse\n* Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.\n* Patients with Burkitt's lymphoma\u002Fleukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell \\[sIg positive and kappa or lambda restricted positivity\\] ALL, with FAB L3 morphology and \u002For a MYC translocation)\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening\n* Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)\n* Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines. Subjects with CNS-2 involvement or with history of CNS disease that have been actively treated are eligible.\n* Patient has an investigational medicinal product within the last 30 days prior to screening.\n* Pregnant or nursing women.\n* Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CAR T-cell infusion. All female patients of childbearing potential must have a negative pregnancy test performed within 48 hours before infusion of CAR T-cells.\n\nThe following are not strictly exclusion criteria but must be discussed with PI\u002FSite-PI:\n\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease\n* Treatment with any prior gene therapy product\n* Has had treatment with any prior anti-CD19\u002Fanti-CD3 therapy, or any other anti-CD19 therapy","0 Years","70 Years",{"count":260,"type":19},40,[52],"The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed\u002F refractory B-lineage leukaemia\u002F lymphoma.",[27,264,265,266,267,268],"Lymphoblastic Leukemia in Children","Lymphoblastic Leukemia, Acute Adult","B-cell Acute Lymphoblastic Leukemia","Large B-cell Lymphoma","CAR",[270,271,272,273],"CAR T-cell therapy","Relapse\u002FRefractory","B-ALL","B-Lineage Lymphoma","2023-03-07",{"date":276,"type":33},"2023-03-09",{"date":278,"type":33},"2022-03-15",{"date":280,"type":19},"2026-12",{"name":282,"class":201},"KK Women's and Children's Hospital",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":15,"minAge":290,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":20,"phases":293,"briefSummary":294,"conditions":295,"keywords":299,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":41},"100442606","phase-1-cartall-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsed-refractory-t-lineage-acute-lymphoblastic-leukaemia-100442606","NCT05043571","CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002F Refractory T-Lineage Acute Lymphoblastic Leukaemia","Anti-CD7 Protein Expression Blocker (PEBL) Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002F Refractory T-Lineage Acute Lymphoblastic Leukaemia (CARTALL)","Inclusion Criteria:\n\n* Diagnosis\u002F Disease define as:\n\n  1. Relapsed T-cell acute lymphoblastic leukaemia\u002F lymphoma as defined by:\n\n     Bone marrow disease = or \\> 0.01% by MRD as determined by flow cytometry\n\n     Or CNS disease as defined as \\> 5 WBCs\u002F uL in CSF with morphological evidence of blasts or biopsy proven recurrence in the eye or brain\n\n     Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites\n  2. Induction failure as defined by:\n\n     MRD = or \\> 1% by flow cytometry at the end of induction on day 33\n\n     Or Failure to achieve morphological remission defined as \\> 5% blasts after standard induction chemotherapy\n  3. Refractory disease as defined by:\n\n     MRD = or \\> 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy\n* Minimum level of pulmonary reserve defined as Grade ≤ 1 dyspnoea and oxygen saturation (SpO2) of \\> 95% on room air\n* Left ventricular systolic function (LVSF) ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram within 3 months of screening\n* Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n* Normal Age-adjusted eGFR Creatinine Clearance within 3 months of screening\n* Alanine aminotransferase ≤ 5 times the upper limit of normal for age\n* Patients with \\> 99% CD7 expression on blast cells will be eligible for anti-CD7 PEBL-CAR-T cell infusion.\n\nExclusion Criteria:\n\n* Failure to meet any of the inclusion criteria\n* Patients who test positive on urine pregnancy testing and are pregnant or are lactating\n* Concomitant genetic syndromes associated with bone marrow failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other bone marrow failure syndrome with the exception of Down syndrome\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease\n* Active or latent hepatitis B or hepatitis C infections within 8 weeks of screening, or any uncontrolled infection at screening\n* Positive Human Immunodeficiency Virus (HIV) test within 8 weeks of screening\n* Grade 2 to 4 acute graft-vs-host disease (GVHD) or extensive chronic GVHD\n* Received an investigational medicinal product within 30 days of screening\n* Central nervous system : Uncontrolled seizures or status epilepticus; increased intra-cranial pressure as evidenced by papilledema and CSF opening pressure \\> 20 cm water; decreased conscious state (any cause)","6 Months","65 Years",{"count":18,"type":19},[22],"The objective of this study is to assess the safety and efficacy of anti-CD7 CAR T-cells in patients with refractory or relapsed T-lineage acute lymphoblastic leukemia (T-ALL).",[296,27,265,264,268,297,298],"Lymphoblastic Leukemia, Acute, Childhood","CAR T-Cell-Related Encephalopathy Syndrome","Refractory Leukemia",[300,301,270],"T-ALL","CAR-T cell therapy","2021-09-07",{"date":304,"type":33},"2021-09-14",{"date":306,"type":19},"2021-09-08",{"date":308,"type":19},"2026-11-01",{"name":310,"class":40},"National University Hospital, Singapore",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":15,"minAge":290,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":20,"phases":321,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":41},"100442231","phase-1-alacart-b-acute-leukemia-and-chimeric-antigen-receptor-t-cell-therapy-for-b-lymphoblastic-leukemia-100442231","NCT05038696","ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.","Chimeric-Antigen Receptor (CAR) T-Cell Therapy Using Multiple CARs and Cell Marker Profiling in High Risk and Relapsed\u002F Refractory B-Lineage Acute Lymphoblastic Leukaemia","ALaCART","Inclusion Criteria:\n\n* Fulfil the Diagnosis\u002F Disease define as:\n\n  1. Relapsed B-cell acute lymphoblastic leukaemia\u002F lymphoma as defined by:\n\n     Bone marrow disease = or \\> 0.01% by MRD as determined by flow cytometry Or CNS disease as defined as \\> 5 WBCs in CSF by morphology, or flow cytometric or molecular evidence of blasts or biopsy proven recurrence in the eye or brain.\n\n     Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites\n  2. Induction failure as defined by Day 33\u002F End of induction:\n\n     MRD ≥ 1% by flow cytometry on the Ma-Spore ALL 2020 protocol Or Failure to achieve morphological remission defined as \\> 5% blasts after standard induction chemotherapy\n  3. Refractory disease as defined by:\n\n     MRD ≥ 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy\n  4. Any high risk features including :\n\n     BCR-ABL1, BCR-ABL1-like, - ABL1-r, PDGFRB-r, TCF3-HLF, MLL-r, hypodiploid ALL (\\\u003C 45 chromosomes), p53 pathogenic mutation as defined by RNA Seq or other molecular methods.\n  5. Patients who are unable to tolerate standard chemotherapy due to significant toxicity as well as other comorbidities\n* Minimum level of pulmonary reserve defined as grade ≤ 1 dyspnoea and oxygen saturation of \\> 95% on room air\n* Left ventricular systolic function ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction ≥ 45% confirmed by echocardiogram within 3 months of screening\n* Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n* Normal Age-adjusted eGFR Creatinine Clearance within 3 months of screening\n* Alanine aminotransferase ≤ 5 times the upper limit of normal for age\n* Patients with \\> 99.9% of CD19 expression on blast cells will be eligible for anti-CD19 CAR T-cell infusion.\n* Patients with partial or absent CD19 expression (\\\u003C 99.9%) on blast cells will be eligible to receive combinations of other CAR T-cells depending on the pattern of antigen expression.\n\nExclusion Criteria:\n\n* Failure to meet any of the inclusion criteria.\n* Patients who test positive on urine pregnancy testing and are pregnant or are lactating\n* Concomitant genetic syndromes associated with BM failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome with the exception of Down syndrome\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease\n* Active or latent hepatitis B or active hepatitis C within 8 weeks of screening, or any uncontrolled infection at screening\n* Positive HIV test within 8 weeks of screening\n* Grade 2 to 4 acute graft-vs-host disease (GVHD) or extensive chronic GVHD\n* Received an investigational medicinal product within 30 days of screening\n* Persistent disease or relapse after other forms of CAR-T cell therapy.","80 Years",{"count":260,"type":19},[22],"The objective of this study is to assess the safety and efficacy of a immunophenotype-adapted approach using CAR T-cells in patients with high-risk, refractory or relapsed B-lineage acute lymphoblastic leukemia (B-ALL).",[296,27,265,264,268,297],[272,301,270],{"date":326,"type":33},"2021-09-09",{"date":328,"type":33},"2021-04-28",{"date":330,"type":19},"2026-08-01",{"name":310,"class":40}]