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Study of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease.

RecruitingPhase 2Ages 12 Years - 65 YearsAllTata Memorial Centre
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In plain words

What the trial is, and whether it could suit you

Study Design Prospective, single center, single arm, Phase II study. Research aims and objectives Aim: To evaluate the efficacy and safety of standardized Withaferin A in steroid refractory acute GvHD in patients post allogeneic stem cell transplantation Primary Objective: To 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). Methodology Treatment 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. Formulation: The standardized root extract of W. somnifera contains 5% of WA w/w. SWA is available as a 500 mg capsule (AshwaMAX) that contains 25 mg of WA. Route of administratio

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients age โ‰ฅ 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) * Evidence of myeloid engraftment (eg, absolute neutrophil count โ‰ฅ0.5 ร— 109 /L for 3 consecutive days) * ECOG performance score of 0 or 1 * Patients with steroid-refractory aGvHD, defined as any of the following: * 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 โ‰ฅ2 mg/kg/d (or equivalent) * 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 โ‰ฅ2 mg/kg/d (or equivalent) * Patients who previously began corticosteroid therapy at a lower dose (โ‰ฅ1 mg/kg/d methylprednisolone) for treatment of skin GvHD or skin GvHD accompanied by upper gut GvHD but develop new GvHD in another organ system * Patients who cannot tolerate a corticosteroid taper, that is, begin corticosteroids at 2.0 mg/kg/d, demonstrate response, but progress before a 50% decrease from the initial starting dose of corticosteroids is achieved Exclusion Criteria: * Known hypersensitivity or contraindications against Withaferin-A. * 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. * Any medical or psychiatric illness which precludes the participant from giving informed consent.
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What it tests

  • Standardized Withaferin A (SWA)
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Where

1 site
Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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