[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658860":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":31,"overallOfficials":37,"centralContacts":42,"locations":47,"responsibleParty":64,"collaborators":13,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":13,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":73,"maxAge":13,"enrollmentInfo":74,"targetDuration":13,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":13,"overallStatus":83,"whyStopped":13,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and Adverse Events (AEs)","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0","Through study completion; an average of 1 year",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Primary Objective:\n\nTo understand how 2 Gy TBI administered before CAR T cell infusion changes the immune system compared to a control group with no TBI, with the potential to improve the infused cell engraftment, efficacy, and sustainability. The primary endpoint is CAR T-cell level. Compare both groups by looking at the CAR T cell levels at standard of care time points 1, 4, 8, 11, 14, 21, and 28, and then every 3 months for a total of a year\n\nSecondary Objectives:\n\nPreliminarily estimate the effects of TBI on circulating inflammatory and immunosuppressive cytokines in the blood. The working hypothesis is that TBI increases circulating inflammatory cytokine levels and reduces immunosuppressive cytokine levels. Secondary endpoints include changes from baseline in circulating inflammatory and immunosuppressive cytokine levels, as measured by multiplex secretome analyses using blood samples collected before TBI, after TBI, and on Day 7 and, optionally, Day 14 after CAR T-cell infusion.\n\nCharacterize changes in circulating immune-cell phenotypes in blood before and after TBI, days 7 and, optionally, day 14 after CAR T. The working hypothesis is that TBI affects circulating T-cell subpopulations and functional phenotypes to facilitate CAR T-cell engraftment. To address this secondary objective, secondary endpoints include changes from baseline in circulating immune-cell phenotypes, T-cell subpopulations, TCR repertoire diversity, clonality, clonal expansion, and polyfunctional T-cell states, assessed using flow cytometry and TCR sequencing in blood samples collected before and after TBI, and on Day 7 and, optionally, Day 14 after CAR T-cell infusion.",[22,28],{"label":23,"type":24,"description":25,"interventionNames":26},"No TBI: No TBI Before CAR T Cell Infusion","EXPERIMENTAL","The Isoplexis Proteomics Platform will be used to interrogate up to 30 protein participants from single cells and bulk serum samples.",[27],"Drug: CAR T cell therapy",{"label":29,"type":24,"description":25,"interventionNames":30},"TBI: TBI 2 Gy Before CAR T Cell Infusion",[27],[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":13},"DRUG","CAR T cell therapy","CAR T cell therapy will be administered as per the institutional guidelines and as per our standard of care",[23,29],[38],{"name":39,"affiliation":40,"role":41},"Bouthaina Dabaja, MD","UT MD Anderson","PRINCIPAL_INVESTIGATOR",[43],{"name":39,"role":44,"phone":45,"phoneExt":13,"email":46},"CONTACT","(713) 563-2406","bdabaja@mdanderson.org",[48],{"facility":40,"status":13,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Houston","Texas","77030","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-95.36327,29.76328,{"lat":58,"lon":57},[61,63],{"name":39,"role":44,"phone":62,"phoneExt":13,"email":46},"713-563-2406",{"name":39,"role":41,"phone":13,"phoneExt":13,"email":13},{"type":65,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100658860","2-gy-total-body-irradiation-as-part-of-conditioning-treatment-for-patients-with-acute-lymphoblastic-leukemia-undergoing-car-t-cell-therapy-100658860",false,"NCT07856758","2 Gy Total Body Irradiation As Part Of Conditioning Treatment For Patients With Acute Lymphoblastic Leukemia Undergoing CAR T Cell Therapy","Inclusion Criteria:\n\n* Patients must have a confirmed diagnosis of Acute Lymphoblastic Lymphoma and are planned to undergo CAT T cell therapy. The patient should not be planned to receive craniospinal irradiation prior to CAR T therapy; the latter group will be excluded from this study. Prior Radiation would not exclude patients from getting 2 Gy TBI, including prior TBI, in the event of a prior stem cell transplant.\n* Age ≥18 years.\n* ECOG performance status ≤2 (Karnofsky ≥60%,).\n* Patients must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,000\u002FmcL Platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN\n\nThe above are guidelines that align with recommendations for any patient who is undergoing CAR T cell therapy.\n\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\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 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 in this protocol must also agree to use adequate contraception before the study, for the duration of study participation, and 6- 12 months after completion of CAR T cell therapy administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents.\n* Patients who need craniospinal irradiation for CNS leukemia prior to CAR T cell therapy.\n* Patients with uncontrolled intercurrent illness (Indicate clearly what type or extent)\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because the conditioning regimen before CAR T, as well as radiation, will have both teratogenic and abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to the treatment of the mother, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.","ALL","18 Years",{"count":75,"type":76},20,"ESTIMATED","INTERVENTIONAL",[79],"NA","The proposed research will compare the effects of TBI prior to CAR T cell infusion to the current standard of care using lymphodepletion.",[82],"Acute Lymphoblastic Leukemia","NOT_YET_RECRUITING","2026-09-29",{"date":86,"type":87},"2026-10-05","ACTUAL",{"date":89,"type":76},"2027-03-01",{"date":91,"type":76},"2030-07-01",{"name":5,"class":6},1]