[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356570":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":63,"centralContacts":68,"locations":77,"responsibleParty":107,"collaborators":25,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":25,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":25,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,16,21,26,31],{"label":9,"type":10,"description":11,"interventionNames":12},"1\u002FRIC Arm","EXPERIMENTAL","Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis",[13,14,15],"Procedure: allo HCT","Drug: RIC","Drug: GVHD prophylaxis",{"label":17,"type":10,"description":18,"interventionNames":19},"2\u002FIOC Arm","Immunosuppression Only Conditioning, plus allogeneic HCT with GVHD prophylaxis",[13,15,20],"Drug: IOC",{"label":22,"type":23,"description":24,"interventionNames":25},"3\u002FDonor Arm","NO_INTERVENTION","Donors for Recipients in Arm 1, Arm 2, Arm 4, or Arm 5",null,{"label":27,"type":10,"description":28,"interventionNames":29},"4\u002FmRIC Arm","modified Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis",[30,13,15],"Drug: mRIC",{"label":32,"type":10,"description":33,"interventionNames":34},"5\u002FATL-RIC Arm","modified Reduced Intensity Conditioning Arm for ATL patients, plus allogeneic HCT with GVHD prophylaxis",[35,13,15],"Drug: ATL-RIC",[37,42,46,51,55,59],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":25},"DRUG","ATL-RIC","e-ATG 40 mg\u002Fkg\u002Fday IV on days -14 and -13, pentostatin 4 mg\u002Fm2\u002Fday IV on days -11 and -7, low-dose cyclophosphamide (5 mg\u002Fkg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, filgrastim or biosimilar drug 5mcg \u002Fkg\u002Fday subcutaneous on days -12, -8, and -4, ruxolitinib 45 mg\u002Fday from day -12 through day -2, and zidovudine 300mg orally three times a day from day -1 through day +50.",[32],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":25},"mRIC","e-ATG 40 mg\u002Fkg\u002Fday IV on days -14 and -13, pentostatin 4 mg\u002Fm2\u002Fday IV on days -11 and -7, lowdose cyclophosphamide (5 mg\u002Fkg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, filgrastim or biosimilar drug 5 mcg\u002Fkg\u002Fday subcutaneous on days -12, -8, and -4.",[27],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":25},"PROCEDURE","allo HCT","Stem cell transplant",[9,17,27,32],{"type":38,"name":52,"description":53,"armGroupLabels":54,"otherNames":25},"RIC","e-ATG 40 mg\u002Fkg\u002Fday IV on days -14 and -13. Pentostatin 4mg \u002Fm2\u002Fday IV on days -11 and -7. Cyclophosphamide 5 mg\u002Fkg orally daily on days -11 through -4. Busulfan IV, pharmacokinetically dosed, on days -3 and -2.",[9],{"type":38,"name":56,"description":57,"armGroupLabels":58,"otherNames":25},"GVHD prophylaxis","High-dose, post-transplantation cyclophosphamide (PTCy) on days +3\n\nand +4 ( 25 mg\u002Fkg\u002Fday on both arms), sirolimus on days +5 through +60, and mycophenolate mofetil (MMF) on\n\ndays +5 through +25.",[9,17,27,32],{"type":38,"name":60,"description":61,"armGroupLabels":62,"otherNames":25},"IOC","e-ATG40 mg\u002Fkg\u002Fday IV on days -14 and -13. Pentostatin 4 mg\u002Fm2\u002Fday IV on days -9 and -5. Cyclophosphamide 5 mg\u002Fkg orally daily on days -9 through -2",[17],[64],{"name":65,"affiliation":66,"role":67},"Dimana Dimitrova, M.D.","National Cancer Institute (NCI)","PRINCIPAL_INVESTIGATOR",[69,74],{"name":70,"role":71,"phone":72,"phoneExt":25,"email":73},"Jessenia C Campos, R.N.","CONTACT","(301) 402-0300","jessenia.campos@nih.gov",{"name":65,"role":71,"phone":75,"phoneExt":25,"email":76},"(240) 858-3647","dimana.dimitrova@nih.gov",[78,96],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-77.10026,38.98067,{"lat":90,"lon":89},[93],{"name":94,"role":71,"phone":95,"phoneExt":25,"email":25},"For more information at the NIH Clinical Center contact National Cancer Institute Referral Office","888-624-1937",{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":84,"countryCode":85,"cosmosGeoPoint":102,"geoPoint":106,"contacts":25},"National Marrow Donor Program","ENROLLING_BY_INVITATION","Minneapolis","Minnesota","55401",{"type":87,"coordinates":103},[104,105],-93.26384,44.97997,{"lat":105,"lon":104},{"type":108,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100356570","phase-2-allogeneic-hematopoietic-cell-transplantation-for-peripheral-t-cell-lymphoma-100356570",false,"NCT03922724","Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma","Phase II Trial of Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma","* INCLUSION CRITERIA-RECIPIENT:\n* Age \\>=12 years\n* Diagnosis of PTCL, confirmed by NCI pathology review, that is relapsed or refractory to prior therapy, and\u002For PTCL where upfront allo HCT in first remission is reasonable (PIT score of intermediate-low risk or higher or supported by clinical practice guidelines)\n\n  --ALK-positive ALCL patients will only be eligible if relapsed or refractory\n* At least one potential 7-8\u002F8 HLA-matched related (excluding an identical twin) or unrelated donor (at HLA-A, -B, -C, and DR), or an HLA-haploidentical related donor, based on initial low resolution unrelated donor search and\u002For at least one biologically-related family member who has at least a 25% chance of being at minimum an HLAhaploidentical match and is potentially suitable to donate based on reported family history. HLA typing of potential donors and\u002For mutation testing does not need to be completed for eligibility.\n* Adequate end-organ function, as measured by:\n\n  * For RIC: Left ventricular ejection fraction (LVEF) \\>= 40% by 2D echocardiogram (ECHO) or MUGA, left ventricular shortening fraction \\>= 20% by ECHO, or LVEF \\>= 30% if the patient has radiologic evidence of aortic, renal, or coronary artery vasculitis. For IOC: LVEF \\>= 30% by 2D ECHO or MUGA.\n  * Pulmonary function tests: DLco (corrected for hemoglobin) and FEV1 \\>= 40% of predicted for the RIC arm, and \\>= 30% predicted for the IOC arm; or in pediatric patients, if unable to perform pulmonary function tests, there should be no evidence of dyspnea at rest, no requirement for supplemental oxygen, and oxygen saturation \\>92% on room air.\n  * Bilirubin \\\u003C= 3.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis) for patients receiving RIC and bilirubin \\\u003C= 5.0 mg\u002FdL for patients receiving IOC (unless due to Gilbert s syndrome or hemolysis); ALT and AST \\\u003C= 10 x ULN for patients receiving RIC or IOC. Patients who are above these bilirubin, ALT, or AST thresholds may be eligible for the RIC or IOC arm if evaluated by a hepatologist who deems the liver function test abnormalities to be potentially disease related, either because of direct involvement by PTCL, due to an associated process such as hemophagocytic lymphohistiocytosis, or as sequelae of prior chemotherapy that is thought to improve with time.\n  * Estimated creatinine clearance of \\>= 50 mL\u002Fmin\u002F1.73 m\\^2, calculated using eGFR in the clinical lab for adults and the Schwartz formula for pediatrics.\n* Karnofsky (adults) or Lansky (children) performance status of \\>= 50% or ECOG performance status of 2 or less for the RIC arm and Karnofsky (adults) or Lansky (children) \\>= 30% or ECOG performance status of 3 or less for the IOC arm\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document\n* Not pregnant or breastfeeding.\n* As therapeutic agents used in this trial may be harmful to a fetus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one year post-allo HCT.\n\nEXCLUSION CRITERIA-RECIPIENT:\n\n* Patients who are receiving any other investigational agents, with the exception of virus-specific cytotoxic T-cells for the treatment of viral infection\u002Freactivation prior to allo HCT.\n* Prohibitive allergy to a study drug or to compounds of similar chemical or biologic composition of the agents (e-ATG, steroids, cyclophosphamide, busulfan, pentostatin, sirolimus, MMF, filgrastim or biosimilar drug) used in the study\n* Lack of central venous access potential\n* Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol or which does not allow for appropriate informed consent\n\nINCLUSION CRITERIA-RELATED DONOR:\n\n-Related donor deemed suitable and eligible, and willing to donate, per clinical evaluations who are additionally willing to donate blood and\u002For peripheral blood stem cells for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.\n\nEXCLUSION CRITERIA-RELATED DONOR:\n\nNone\n\nINCLUSION CRITERIA (UNRELATED DONOR):\n\n-Unrelated donors will be evaluated in accordance with existing NMDP Standard Policies and Procedures, available at: http:\u002F\u002Fbethematch.org\u002FAbout-Us\u002FGlobal-transplantnetwork\u002F Standards\u002F, except for the additional requirement of EBV serostatus testing for clinical purposes of donor selection. Note that participation in this study is offered to all unrelated donors but not required for clinical donation, so it is possible that not all unrelated donors will enroll on this study. Unrelated donors only enroll if they contribute research specimens, which is optional.\n\nEXCLUSION CRITERIA (UNRELATED DONOR):\n\n-Unrelated donors: failure to qualify as a National Marrow Donor Program (NMDP) donor per current NMDP Standards, available at: http:\u002F\u002Fbethematch.org\u002FAbout-Us\u002FGlobaltransplant- network\u002FStandards\u002F. Exceptions to donor eligibility (e.g. foreign travel, tattoos) do not automatically exclude the donor and will be reviewed by the PI.",true,"ALL","12 Years","120 Years",{"count":121,"type":122},330,"ESTIMATED","INTERVENTIONAL",[125],"PHASE2","Background:\n\nLymphoma is a type of blood cancer. Blood cell transplant can cure some people with lymphoma. Researchers want to see if they can limit the complications transplant can cause.\n\nObjective:\n\nTo test if a stem cell transplant can cure or control lymphoma. Also to test if new ways of getting a recipient ready for a transplant may result in fewer problems and side effects.\n\nEligibility:\n\nRecipients: People ages 12 and older with peripheral T cell lymphoma that does not respond to standard treatments\n\nDonors: Healthy people ages 18 and older whose relative has lymphoma\n\nDesign:\n\nParticipants will be screened with:\n\nPhysical exam\n\nBlood and urine tests\n\nBone marrow biopsy: A needle inserted into the participant s hip bone will remove marrow.\n\nDonors will also be screened with:\n\nX-rays\n\nRecipients will also be screened with:\n\nLying in scanners that take pictures of the body\n\nTumor sample\n\nDonors may donate blood. They will take daily shots for 5 7 days. They will have apheresis: A machine will take blood from one arm and take out their stem cells. The blood will be returned into the other arm.\n\nRecipients will be hospitalized at least 2 weeks before transplant. They will get a catheter: A plastic tube will be inserted into a vein in the neck or upper chest. They will get antibody therapy or chemotherapy.\n\nRecipients will get the transplant through their catheter.\n\nRecipients will stay in the hospital several weeks after transplant. They will get blood transfusions. They will take drugs including chemotherapy for about 2 months.\n\nRecipients will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.",[128,129,130],"Peripheral T-cell Lymphomas","Lymphoproliferative Disorders","Immune System Diseases",[132,133,134,135],"Autoimmunity","Immune Dysregulation","Congenital","Opportunistic Infection","2026-07-01",{"date":138,"type":139},"2026-07-02","ACTUAL",{"date":141,"type":139},"2019-04-18",{"date":143,"type":122},"2030-10-31",{"name":66,"class":6},2]