[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648325":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":67,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":20,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":20,"enrollmentInfo":83,"targetDuration":20,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":57,"whyStopped":20,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose cyclosphosphamide","EXPERIMENTAL","Single Arm study and cyclophosphamide at a lower dose (25 mg\u002Fkg x 2 days)",[13],"Drug: Cyclophosphamide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Cyclophosphamide","Post-transplant Immunosuppression:\n\n● GvHD prophylaxis regimen will consist of two doses of cyclophosphamide on D+3 and D+4 at 25mg\u002Fkg\u002Fday (that is half of the usual standard dose) with calcineurin inhibitor and mycophenolate mofetil \u002F mycophenolate sodium. Mesna will be given with cyclophosphamide (this is standard of care). The use of calcineurin inhibitors and mycophenolate mofetil \u002F mycophenolate sodium will be as per standard practice.\n\nAdministration of study treatments\n\n* Hydration and MESNA\n* Adequate intravenous hydration with normal saline will be started at least 4 hours prior to cyclophosphamide, and will be continued till 24 hours post completion of 2nd dose of cyclophosphamide as per standard institutional practice.\n* Mesna will be administered as a continuous infusion starting from Day+3 till 24 hours after the second dose of PTCy.\n* Cyclophosphamide\n* Cyclophosphamide would be administered on D+3 and D+4 \\[first dose starting between 60 - 72 hrs after stem cell infusion\\]",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Dr Sachin Punatar, MBBS MD DM medical oncology","CONTACT","09833445041","drsachin_punatar@yahoo.in",{"name":28,"role":24,"phone":20,"phoneExt":20,"email":29},"Dr.Akanksha Chichra, FNB,,DNB Pediatric oncology","akanksha7@hotmail.com",[31,56],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Advanced Centre for Treatment, Research and Education in Cancer","NOT_YET_RECRUITING","Navi Mumbai","Maharashtra","410210","India","IN",{"type":40,"coordinates":41},"Point",[42,43],73.01582,19.03681,{"lat":43,"lon":42},[46,48,50,53],{"name":47,"role":24,"phone":25,"phoneExt":20,"email":26},"Sachin Punatar, MBBS DM MD Medical Oncology",{"name":49,"role":24,"phone":20,"phoneExt":20,"email":29},"Akanksha Chichra, FNB,DNB Pediatric Oncology",{"name":51,"role":52,"phone":20,"phoneExt":20,"email":20},"Dr.Sachin Punatar, MBBS DM MD Medical Oncology","PRINCIPAL_INVESTIGATOR",{"name":54,"role":55,"phone":20,"phoneExt":20,"email":20},"Lingaraj Nayak, MBBS DM MD Medical Oncology","SUB_INVESTIGATOR",{"facility":32,"status":57,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"RECRUITING",{"type":40,"coordinates":59},[42,43],{"lat":43,"lon":42},[62,64,66],{"name":47,"role":24,"phone":25,"phoneExt":63,"email":26},"8679\u002F8696",{"name":49,"role":24,"phone":65,"phoneExt":63,"email":29},"9004920555",{"name":47,"role":52,"phone":20,"phoneExt":20,"email":20},{"type":52,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Dr Sachin Punatar","Professor & Medical Oncologist",[71],{"name":72,"class":73},"Indian Council of Medical Research","OTHER_GOV","100648325","phase-2-to-study-lower-dose-of-cyclophosphamide-after-stem-cell-transplant-for-blood-cancers-100648325",false,"NCT07719946","To Study Lower Dose of Cyclophosphamide After Stem Cell Transplant for Blood Cancers","Phase II Trial of Reduced Dose Post Transplant Cyclophosphamide After Haploidentical Hematopoietic Stem Cell Transplant in Hematological Malignancies","Inclusion Criteria: -\n\n* Patients age ≥ 18 years\n* ECOG performance score of 0 or 1\n\nExclusion Criteria: -\n\n* Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n* Any medical or psychiatric illness which precludes the participant from giving informed consent.\n* Organ function criteria: Serious organ dysfunctions:\n* Serious cardiac dysfunction: Left ventricular ejection fraction \\\u003C 45%; no uncontrolled arrhythmias or symptomatic cardiac disease.\n* Serious pulmonary organ dysfunction: Symptomatic pulmonary disease; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO) =\\\u003C 50% of predicted (corrected for haemoglobin).\n* Serious renal dysfunction: Measured serum creatinine clearance =\\\u003C 60 mL\u002Fmin.\n* Serious Hepatic dysfunction: Total serum bilirubin more than twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3-fold higher than laboratory upper normal limits.","ALL","18 Years",{"count":84,"type":85},20,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","Cyclophosphamide is the name of a medicine given to prevent graft-versus-host-disease (GVHD) after half-matched transplant. This medicine is given on the 3rd and 4th day after stem cell transplant. The standard dose of this medicine is 50 mg per kg of the patient's weight given on the 3rd and the 4th day. However, using this medicine at this dose of 50 mg \u002F kg for 2 days is associated with certain problems such as susceptibility to infections and delay in the recovery of the immune system after stem cell transplant. Therefore, several research groups across the world have tried to reduce the dose of cyclophosphamide that is used. These groups have tried reducing the dose from 50 mg per kg to 25-40 mg per kg. These studies have shown that the reduced dose cyclophosphamide is equally effective in preventing GVHD. However, these studies are carried out on small numbers of patients and further studies are essential to confirm whether reduced dose of cyclophosphamide is equally effective. In this study, we will use cyclophosphamide at a lower dose (25 mg\u002Fkg x 2 days) and see if the lower dose results in equal efficacy but lesser toxicities This is a single-arm study. All participants will receive the same treatment; there is no comparison group.\n\nParticipants will:\n\nAdults (age ≥18) undergoing haploidentical stem cell transplant for blood cancers Receive low-dose cyclophosphamide (25 mg\u002Fkg\u002Fday) on Day 3 and Day 4 after transplant Also receive standard GVHD preventive medicines (calcineurin inhibitor and mycophenolate) Undergo regular blood tests, immune system monitoring, and GVHD assessments Have immune cell and cytokine profiles analyzed through blood samples",[91,92],"Haploidentical Hematopoietic Stem Cell Transplant","Hematological Malignancies",[9],"2026-07-17",{"date":96,"type":97},"2026-07-22","ACTUAL",{"date":99,"type":97},"2025-03-26",{"date":101,"type":85},"2028-11-12",{"name":5,"class":6},2]