Health Condition 1: D898- Other specified disorders involving the immune mechanism, not elsewhere classified
Conditions
Interventions
Intervention1: Standardized Withaferin-A:
Name of the Intervention-Standardized Withaferin A (Standardized root extract of Withania somnifera)
Formulation-The standardized root extract of Withania s
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| THE OBJECTIVE RESPONSE RATE (ORR)Timepoint: AT DAY 28 FROM THE START OF STANDARDIZED WITHAFERIN A (SWA) | — |
Secondary
| Measure | Time frame |
|---|---|
| -To evaluate the ORR at other defined time points Day 14 & Day 56 from initiation of SWA -To study the Non relapse Mortality NRM at 1 year post transplant -To study the Relapse rate at 1 year post transplant -To study the Overall Survival OS at 1 year post transplant -To study the incidence of chronic GvHD at 1 year post transplant -To study the incidence of adverse effects attributed to SWA -Reduction of steroid dose by more than equal to 30% from baseline will be calculated for all patients on day 28 after start of SWA. -To measure the JAK2 STAT3 levels, JAK2 STAT3 receptor kinetics at baseline before start of SWA & Day +7 & Day +28 post initiation of SWA. -Immune cell phenotype cytokine profile & pharmacokinetics of WA in patients post treatment with SWA at baseline, Day +7, Day +14, Day +28, Day+100 post HSCT. Timepoint: Overall response rate assessed at Day 14 & Day 56 from start of standardized Withaferin A. | — |
Countries
India
Contacts
Public ContactDr Akanksha Chichra
Advanced Centre for Treatment, Research and Education in Cancer Tata Memorial Centre
Outcome results
None listed