Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation

Description

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.

Conditions

Acute Myeloid Leukemia, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia, Juvenile Myelomonocytic Leukemia

Study Overview

Study Details

Study overview

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.

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

Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation

Condition
Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Saint Petersburg

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States, 33701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patient is 1 year to 21 years of age.
  • 2. Patient has a diagnosis of AML, MDS, MDS/AML, MPAL, or JMML. Note: patients are allowed to have received a HMA or HDACi prior to undergoing alloHCT.
  • 3. Patient has undergone allogeneic hematopoietic cell transplantation (no restrictions on conditioning regimen, donor or stem cell source, or GVHD prophylaxis regimen).
  • 4. Patient and/or parent(s) or legal guardian(s) are capable of understanding the study, including potential benefits and risks, and sign written informed consent. Age-appropriate assent will be obtained.
  • 5. Female patient of childbearing potential has a negative screening pregnancy test (urine or serum, as per local institutional standard).
  • 6. Female patient with infant(s) agrees not to breastfeed her infant(s) while on study.
  • 7. Patient of child-bearing potential (male and female) agrees to use effective method of contraception during the study.
  • 1. Patient is enrolled on a clinical trial with investigational post-transplant medications. Note: trials involving defibrotide, post-transplant cyclophosphamide, and Lactobacillus plantarum are permitted. Other trials involving investigational medications that aren't leukemia or GVHD-directed may also be permitted after consultation with the overall PI.
  • 2. Patient has a planned administration of non-protocol chemotherapy, radiation therapy, donor leukocyte infusion, or immunotherapy during the planned study period.
  • 3. Patient has a known allergy to azacitidine or vorinostat.
  • 4. Patient has chronic myelogenous leukemia.
  • 5. Concomitant use of coumarin-derived anticoagulants or valproic acid.

Ages Eligible for Study

1 Year to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins All Children's Hospital,

Cassandra Josephson, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins All Children's Hospital

Study Record Dates

2025-10-30