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Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation
Sponsor: Johns Hopkins All Children's Hospital
Summary
The objective of this study is to evaluate the maximum tolerated (MTD) of vorinostat used in combination with low-dose azacitidine after allogeneic hematopoietic cell transplantation (alloHCT) for prevention of relapse of childhood myeloid malignancies.
Official title: Epigenetic Modification for Relapse Prevention: a Dose-finding Study of Vorinostat Used in Combination With Low-dose Azacitidine in Children Undergoing Allogeneic Hematopoietic Cell Transplantation for Myeloid Malignancies
Key Details
Gender
All
Age Range
1 Year - 21 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2019-05-01
Completion Date
2026-10-30
Last Updated
2025-08-11
Healthy Volunteers
No
Conditions
Interventions
Vorinostat
Vorinostat will be administered concurrent with low-dose azacitidine post-transplant, on days 1-7 and 15-21 of 28 day cycles. This is an oral medication.
Azacitidine Injection
Azacitidine will be administered on days 1-5 of each 28 day cycle, either by IV or subcutaneous injection. The dose of azacitidine will be fixed, with no dose-escalation.
Locations (1)
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States