NCT03843528Active, not recruitingPhase 1
Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation
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
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 24 Jan 2019
- Start date
- 1 May 2019
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- Johns Hopkins All Children's Hospital
- NCT number
- NCT03843528
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 15
- From 1 May 2019 to the primary completion date, 30 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Concomitant use of coumarin-derived anticoagulants or valproic acid.
- \-
Other illness
- Patient has a known allergy to azacitidine or vorinostat.
Lab values
- Patient has a planned administration of non-protocol chemotherapy, radiation therapy, donor leukocyte infusion, or immunotherapy during the planned study period.
Other
- Patient has chronic myelogenous leukemia.
Who the study is looking for
- Patient is 1 year to 21 years of age.
- 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.
- Patient has undergone allogeneic hematopoietic cell transplantation (no restrictions on conditioning regimen, donor or stem cell source, or GVHD prophylaxis regimen).
- 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.
- Female patient of childbearing potential has a negative screening pregnancy test (urine or serum, as per local institutional standard).
- Female patient with infant(s) agrees not to breastfeed her infant(s) while on study.
- Patient of child-bearing potential (male and female) agrees to use effective method of contraception during the study.
Age in the registry: 1 year to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins All Children's Hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.