[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steriod-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steriod-refractory":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100647328","phase-2-study-of-standardized-withaferin-a-for-the-treatment-of-steroid-refractory-acute-graft-versus-host-disease-100647328",false,"NCT07708987","Study of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease.","A Phase II Clinical Trial of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease","Withaferin_A","Inclusion Criteria:\n\n* Patients age ≥ 12 years with a hematological malignancy who have undergone allogeneic stem cell transplant with matched related donor (MRD), Haploidentical (Haplo) donor or matched unrelated donor (MUD)\n* Evidence of myeloid engraftment (eg, absolute neutrophil count ≥0.5 × 109 \u002FL for 3 consecutive days)\n* ECOG performance score of 0 or 1\n* Patients with steroid-refractory aGvHD, defined as any of the following:\n* Patients with progressive GvHD (ie, increase in stage in any organ system or any new organ involvement) after 3 days of primary treatment with methylprednisolone ≥2 mg\u002Fkg\u002Fd (or equivalent)\n* Patients with GvHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 7 days of primary treatment with methylprednisolone ≥2 mg\u002Fkg\u002Fd (or equivalent)\n* Patients who previously began corticosteroid therapy at a lower dose (≥1 mg\u002Fkg\u002Fd methylprednisolone) for treatment of skin GvHD or skin GvHD accompanied by upper gut GvHD but develop new GvHD in another organ system\n* Patients who cannot tolerate a corticosteroid taper, that is, begin corticosteroids at 2.0 mg\u002Fkg\u002Fd, demonstrate response, but progress before a 50% decrease from the initial starting dose of corticosteroids is achieved\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindications against Withaferin-A.\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.","ALL","12 Years","65 Years",{"count":21,"type":22},34,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Study Design Prospective, single center, single arm, Phase II study.\n\nResearch aims and objectives Aim:\n\nTo evaluate the efficacy and safety of standardized Withaferin A in steroid refractory acute GvHD in patients post allogeneic stem cell transplantation\n\nPrimary Objective:\n\nTo evaluate the objective Response Rate (ORR) at Day 28 from the start of SWA defined as the proportion of patients achieving Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR).\n\nMethodology\n\nTreatment plan and Interventions Administration of study treatment Name of the intervention: Standardized WA (standardized root extract of Withania somnifera. This will be provided free of cost to the trial patients.\n\nFormulation: The standardized root extract of W. somnifera contains 5% of WA w\u002Fw. SWA is available as a 500 mg capsule (AshwaMAX) that contains 25 mg of WA.\n\nRoute of administration: Per-oral (P\u002FO) Dose schedule: The dose of SWA is 1500mg\u002Fday. It will be administered as 3 capsules of 500 mg once a day.\n\nDuration of treatment:\n\n* Every patient will receive treatment for at least 12 weeks followed by a taper as per physician's discretion. WA can be tapered after 12 weeks if the patient has achieved CR or VGPR and has discontinued corticosteroids for at least 4 weeks.\n* Dose adjustments\u002Fmodifications: If the patient experiences any grade ≥3 toxicities related to SWA, further administration of SWA will be withheld immediately. Once the severity of the adverse event reduces to grade ≤1, the study agent will be rechallenged with 25% dose reduction. The same strategy will be adopted for successive grade ≥3 toxicities. If the drug is not tolerated at 25% of original dose (100 mg), no further rechallenge will be attempted.\n* Corticosteroid tapering will be done as per the treating physician's discretion and clinical condition of the patient.",[28,29,30],"Hematological Malignancy","GVHD - Graft-Versus-Host Disease","Steriod Refractory",[32],"Withaferin A","RECRUITING","2026-07-11",{"date":36,"type":37},"2026-07-16","ACTUAL",{"date":39,"type":37},"2023-09-23",{"date":41,"type":22},"2028-09-25",{"name":43,"class":44},"Tata Memorial Centre","OTHER"]