Vorinostat for Graft-versus-host Disease (GVHD) Prevention in Non-Malignant Adolescent and Young Adults (AYA) Population (NCT06995521)
Use of Vorinostat as GVHD Prophylaxis in Children, Adolescents, and Young Adults With Non-Malignant Disorders Undergoing Allogeneic Blood and Marrow Transplantation
🩺 Plain-English Summary (8th-Grade Level)
This is a single-arm, open label, phase 2 study to determine the safety and efficacy of vorinostat without serotherapy as GVHD prophylaxis when combined with either tacrolimus and methotrexate or post-transplant cyclophosphamide, tacrolimus, and mycophenolate in patients aged 1 to 26 years of age with non-malignant disorders undergoing bone marrow transplant following myeloablative conditioning.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (17 items).
Location: University of Michigan — Ann Arbor, Michigan
Age range: 1 Year to 26 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- \- Previous diagnosis of Fanconi anemia, dyskeratosis congenita or other telomere biology disorders, inherited genetic conditions known to adversely affect DNA-repair, or other disorders with known chemo- or radiosensitivity. Additional testing may be conducted per investigator discretion but is not required for enrollment.
- Diagnosis of idiopathic severe aplastic anemia
- Diagnosis of severe combined immunodeficiency syndrome
- Diagnosis of malignancy within the last 5 years.
- Diagnosis of Epstein-Barr virus (EBV)-driven lymphoproliferative disorder within the last 5 years
- Uncontrolled bacterial, viral, or fungal infection at the time of enrollment
- Seropositive for HIV or HTLV
- Active hepatitis B or C
- Female patients that are pregnant or breast-feeding
- Inability to take oral medications.
- History of allergy to Vorinostat, related compounds, or any drugs used as part of the conditioning regimen or GVHD prophylaxis.
- Patients with transfusion-dependent anemia (≥8 packed red blood cell (PRBC) transfusions/year or ≥20 lifetime transfusions) that have a liver iron content of \>8 milligram (mg) Iron(Fe)/Gram dry weight or evidence of bridging fibrosis or cirrhosis on biopsy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Michigan — Ann Arbor, Michigan
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in GVHD
- TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT — Palo Alto, California
- Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation — San Diego, California
Explore by condition: All GVHD clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.