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

NCT07708987 · tracked via the Priya Life Science India tracker

Sponsor

Tata Memorial Centre

Phase

Phase 2

Started

2023-09-23

Last updated

2026-07-16

Condition(s) studied

Hematological MalignancyGVHD - Graft-Versus-Host DiseaseSteriod Refractory

Investigational drug(s) / intervention(s)

Standardized Withaferin A (SWA)

Standardized Withaferin A (SWA): Withaferin-A (standardized root extract of Withania somnifera ) Route of administration: Per-oral (P/O) Dose schedule: The dose of SWA is 1500mg/day. It will be administered as 3 capsules of 500 mg once a day. Duration of treatment 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.

Study summary

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 administration: Per-oral (P/O) Dose schedule: The dose of SWA is 1500mg/day. It will be administered as 3 capsules of 500 mg once a day.

Duration of treatment:

* 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.
* Dose adjustments/modifications: 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.
* Corticosteroid tapering will be done as per the treating physician's discretion and clinical condition of the patient.

Eligibility

Sex

ALL

Min age

12 Years

Max age

65 Years

Healthy volunteers

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.

Primary outcome measure(s)

OBJECTIVE RESPONSE RATE (ORR) — Day 28 after initiation of standardized Withaferin A (SWA)
OBJECTIVE RESPONSE RATE (ORR)

Trial sites (1)

Facility	City	Region	Status
Advanced Centre for Treatment, Research and Education in Cancer	Navi Mumbai	Maharashtra	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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