Condition: Hematopoietic Stem Cell Transplant (HSCT) · GVHD - Graft-Versus-Host Disease · Hematological Malignancy · Sponsor: Tata Memorial Centre
What is acute Graft versus host disease (aGvHD)? GvHD is a complication that can occur after an allogeneic stem cell transplant resulting in damage to some organs. The death rate of GvHD patients is 15-40%. In GvHD, the donated peripheral blood stem cells or bone marrow view the recipient's body as foreign, and the donated cells/bone marrow harm the body. aGvHD usually develops in skin, liver or gastrointestinal tract, and symptoms might appear within few weeks after transplant. Symptoms of acute GvHD are observed as skin rash or reddened areas on the skin, yellow discoloration of the skin and/or eyes, and abnormal blood test results, nausea, vomiting, diarrhea, or abdominal cramping. What is the current prevention used for GvHD? To prevent development of GvHD many standard drugs like cyclosporine (CSA), tacrolimus (TAC), methotrexate (MTX), mycophenolate mofetil (MMF), rapamycin and cyclophosphamide are given. What is standardized Withaferin-A (SWA)? Withaferin-A (WA) is the main active component of Withania somnifera (Ashwagandha). It has been shown in many studies to have properties of healing and immune-modulation (improving the immune system). Studies have been done in our Clinical Pharmacology Laboratory that have shown a significant beneficial effect of this drug, when added to the standard drugs used for prophylaxis of GvHD, on reducing the risk of acute GvHD. The drug has also been tested and proven to be very safe in humans. What is the rationale of this trial? A…
This description comes directly from the study's public registry record.
Dr Akanksha Chichra, FNB, DNB Pediatric oncology · 91 22- 68735000 · akanksha7@hotmail.com
Dr Sachin Punatar, MBBS MD DM Medical Oncology · 91 22- 68735000 · drsachin_punatar@yahoo.in
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| Advanced Centre for Treatment, Research and Education in Cancer | Navi Mumbai, Maharashtra, India | Recruiting |
| Advanced Centre for Treatment, Research and Education in Cancer | Navi Mumbai, Maharashtra, India | Recruiting |
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