[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607812":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":89,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Reduced dose","EXPERIMENTAL","cyclophosphamide administered at 35mg\u002Fkg\u002Fday (Adjusted body weight) on days +3 and +4",[13],"Drug: Cyclophosphamide 35mg\u002Fkg\u002Fday",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard dose","ACTIVE_COMPARATOR","cyclophosphamide administered at 50mg\u002Fkg\u002Fday (Adjusted Body Weight) on days +3 and +4",[19],"Drug: Cyclophosphamide 50mg\u002Fkg\u002Fday",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Cyclophosphamide 35mg\u002Fkg\u002Fday","Cyclophosphamide will be administered intravenously (IV) post-HSCT at the experimental dose (70 mg\u002Fkg, divided into two doses of 35 mg\u002Fkg\u002Fday (Adjusted Body Weight) on days +3 and +4).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cyclophosphamide 50mg\u002Fkg\u002Fday","Cyclophosphamide will be administered intravenously (IV) post-HSCT at the standard dose (100 mg\u002Fkg, divided into two doses of 50 mg\u002Fkg\u002Fday (Adjusted Body Weight) on days +3 and +4).",[15],[32],{"name":33,"affiliation":5,"role":34},"Mohamad MOHTY, PU-PH","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","00 33 1.49.28.26.20","mohamad.mohty@inserm.fr",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Remy DULERY","remy.dulery@aphp.fr",[44],{"facility":45,"status":26,"city":46,"state":26,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Saint Antoine Hospital - Hematology Department","Paris","75012","France","FR",{"type":51,"coordinates":52},"Point",[53,54],2.3488,48.85341,{"lat":54,"lon":53},[57,60],{"name":58,"role":37,"phone":38,"phoneExt":26,"email":59},"Florent MALARD, PU-PH","malardf@yahoo.fr",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100607812","phase-3-reduced-post-transplant-cyclophosphamide-dose-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplantation-for-hematological-malignancies-100607812",false,"NCT07193420","Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies","Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies: a Phase III Randomized Study","REDUCy","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed hematological malignancy with an indication for allogeneic HSCT\n* Presence of a haploidentical donor willing to donate PBSC\n* Patient planned to receive a thiotepa-based conditioning regimen\n* Provision of written informed consent Affiliation to a social security system (excluding \"Aide Médicale d'État\")\n\nExclusion Criteria:\n\n* Karnofsky performance status \\\u003C 70%\n* Life expectancy \\\u003C 1 month, as determined by the attending physician\n* Acute or chronic heart failure, defined as left ventricular ejection fraction \\\u003C 40%\n* Pulmonary dysfunction with diffusion capacity \\\u003C 50% of predicted values\n* Renal impairment with estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin (calculated using the CKD-EPI formula)\n* Decompensated hemolytic anemia\n* Fanconi anemia and other DNA breakage repair disorders\n* Acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy\n* Obstruction of urinary outflow\n* Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines\n* Combination with products containing Hypericum perforatum\n* Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein (P-gp) or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and\u002For life-threatening events, e.g., bosentan, dabigatran etexilate and aliskiren\n* Active non-controlled infectious disease\n* Positive HIV status\n* Pregnancy, breast-feeding, or refusal to use effective contraception for the duration of the study and 6 months after the last treatment dose\n* Individuals under legal protection measures or unable to provide consent (e.g., severe neurological or psychiatric disorders, or deprivation of liberty by judicial or administrative decision)\n* Hypersensitivity to the active substance or any of the excipients\n* Concurrent participation in another investigational therapeutic study\n* Inability to comply with study procedures as assessed by the investigator based on objective criteria, including but not limited to:\n\n  * Significant language barrier in the absence of adequate translation support\n  * Social or geographic situation preventing follow-up and adherence to visit schedule\n  * Ongoing substance abuse likely to interfere with protocol compliance\n  * Documented cognitive or functional impairment not otherwise covered under legal protection","ALL","18 Years",{"count":74,"type":75},180,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","Phase III comparative, open-label, randomized (1:1) trial designed to evaluate the efficacy of reducing the total dose of PTCy to 70 mg\u002Fkg on GREFS compared to the standard dose of 100 mg\u002Fkg, in patients undergoing haploidentical HSCT for the treatment of a hematological malignancy, two years after HSCT.",[81,82,83],"GVHD - Graft-Versus-Host Disease","HSCT","Haploidentical Stem Cell Transplantation",[85,86,87,88],"Cyclophosphamide toxicities","Cyclophosphamide dose reduction","Graft-Versus-Host Disease: GVHD","Hematopoietic stem cell transplantation","NOT_YET_RECRUITING","2026-05-07",{"date":92,"type":93},"2026-05-12","ACTUAL",{"date":95,"type":75},"2026-06",{"date":97,"type":75},"2030-06",{"name":5,"class":6},1]