Standardized Withaferin A for steroid-refractory acute GVHD after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm Phase II trial conducted at a single center to evaluate the safety and efficacy of standardized Withaferin A in patients with steroid-refractory acute GVHD after allogeneic hematopoietic stem cell transplantation. The primary endpoint is the objective response rate at Day 28, defined as CR, VGPR, or PR. Participants receive 1500 mg/day of standardized WA (AshwaMAX 500 mg capsules, containing 25 mg WA) as oral capsules, with treatment provided at no cost. Secondary and exploratory objectives include responses at Day 14 and Day 56, non-relapse mortality, relapse, overall survival, chronic GVHD incidence at 1 year, adverse events, steroid-sparing effects, and immunologic/pharmacokinetic assessments over multiple time points up to 180 days post-transplant.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)
* Evidence of myeloid engraftment (eg, absolute neutrophil count ≥0.5 × 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 ≥2 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 ≥2 mg/kg/d (or equivalent)
* 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
* 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.

Where it's running

• Advanced Centre for Treatment, Research and Education in Cancer
  Navi Mumbai, Maharashtra, India Recruiting

Study contacts

• Principal investigator: Dr.Akanksha Chichra, DNB — Advanced Centre for Treatment, Research and Education in Cancer
• Study coordinator: Dr Akanksha Chichra, DNB
• Email: akanksha7@hotmail.com
• Phone: 27405000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.