Study of Standardized Withaferin-A for the treatment of Steroid Refractory acute Graft versus Host Disease.
- Conditions
- Health Condition 1: D898- Other specified disorders involving the immune mechanism, not elsewhere classified
- Registration Number
- CTRI/2023/07/055361
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.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).
2.Evidence of myeloid engraftment (eg, absolute neutrophil count =0.5 × 109 /l for 3 consecutive days).
3.Ecog performance score of 0 or 1.
4.Patients with steroid-refractory acute graft versus host disease (GVHD), defined as any of the following:
i.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/kg/d (or equivalent).
ii.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/kg/d (or equivalent).
iii.Patients who previously began corticosteroid therapy at a lower dose (=1 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.
iv.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.
1.Known hypersensitivity or contraindications against Withaferin A.
2.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.
3.Any medical or psychiatric illness which precludes the participant from giving informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method THE OBJECTIVE RESPONSE RATE (ORR)Timepoint: AT DAY 28 FROM THE START OF STANDARDIZED WITHAFERIN A (SWA)
- Secondary Outcome Measures
Name Time Method