ACTIVE_NOT_RECRUITING

Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2019-05-01

Study Completion:2026-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03843528

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.

Ages Eligible for Study:1 Year to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Cassandra Josephson, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins All Children's Hospital

Study Locations (Sites)

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

United States

Collaborators and Investigators

Sponsor: Johns Hopkins All Children's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-01

Study Completion Date2026-10-30

Study Record Updates

Study Start Date2019-05-01

Study Completion Date2026-10-30

Terms related to this study

Additional Relevant MeSH Terms

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