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ACTIVE NOT RECRUITING
NCT03843528
PHASE1

Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation

Sponsor: Johns Hopkins All Children's Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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