Withaferin A to help prevent graft-versus-host disease 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, non-randomized Phase I/II study evaluating the safety and potential effectiveness of oral standardized Withaferin A in addition to the usual GvHD prophylaxis. Participants receive SWA starting Day +1 to Day +90 alongside calcineurin inhibitor and methotrexate, with dose escalation across four levels to determine the maximum tolerated dose. The study targets adults with hematological malignancies undergoing an 10/10 matched related donor transplant and monitors for acute GvHD, toxicity, and pharmacokinetics. Data from the initial safety period guide dose selection for the Phase 2 arm. The trial is conducted at sites in Navi Mumbai, with Tata Memorial Centre as the lead sponsor and collaboration from the Indian Council of Medical Research.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ECOG performance score of 0 or 1
2. Adequate liver function (Total serum bilirubin \< twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3-fold higher than laboratory upper normal limits)
3. Adequate renal function (creatinine clearance \> 50 ml/min)
4. Adequate cardiac function (LVEF\>40%)
5. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.
6. Signed, written informed consent

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
4. Pregnancy, lactation, or inadequate contraception.

Where it's running

• 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

Study contacts

• Study coordinator: Dr Akanksha Chichra, FNB, DNB Pediatric oncology
• Email: akanksha7@hotmail.com
• Phone: 91 22- 68735000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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

  This study tests whether a standardized extract of Withania somnifera (Withaferin A) given by mouth can help patients with steroid-refractory acute GVHD after an allogeneic stem cell transplant.

  Recruiting Phase 2 Tata Memorial Centre · Navi Mumbai, Maharashtra · NCT07708987

• Middle East study of bloodstream infections in blood cancer patients and HSCT recipients

  This is an observational study to see how bloodstream infections affect adults with blood cancers or after stem cell transplants across several Middle East countries.

  Recruiting at 9 sites Hamad Medical Corporation · Amman and 8 other locations · NCT07900542

• Post transplant cyclophosphamide, bortezomib, and sitagliptin to prevent graft-versus-host disease after allogeneic transplantation

  This study tests whether a combination of post-transplant cyclophosphamide, bortezomib, and sitagliptin can prevent GvHD in adults undergoing reduced-intensity allogeneic stem cell transplantation from matched related or unrelated donors.

  Recruiting Phase 1/2 Northwell Health · New Hyde Park, New York · NCT07675174

• Venetoclax plus azacitidine consolidation vs standard chemotherapy before stem cell transplant in high-risk AML

  This study tests whether a venetoclax-containing consolidation helps newly diagnosed high-risk AML patients who have CR/CRi after VA induction to improve outcomes before allo-HSCT.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07425782

• Psychiatric Symptoms and Quality of Life in Graft-versus-Host Disease

  This project will see if psychiatric symptoms like depression are linked to GvHD symptom severity and health-related quality of life in adults with graft-versus-host disease.

  Recruiting Medical University of Gdansk · Gdansk, Pomeranian Voivodeship · NCT07314892

• See if a behavioral coaching plus at-home exercise can help older blood cancer survivors slow aging

  Aimed at people 50 and older who have had a blood cancer, this trial tests whether combining coaching with a virtual exercise program can help slow aging and improve health.

  Recruiting University of Nebraska · Omaha, Nebraska · NCT07292272

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.