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Epigenetic drugs aim to stop cancer return after transplant in kids

NCT ID NCT03843528

Disease control Sponsor: Johns Hopkins All Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial tests whether adding two drugs—vorinostat and low-dose azacitidine—after a stem cell transplant can help prevent relapse in children with certain myeloid cancers. The study includes children aged 1 to 21 with acute myeloid leukemia or related conditions. Researchers are looking for the safest dose of vorinostat when used with azacitidine, while also tracking side effects, graft-versus-host disease, and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vorinostat and low-dose azacitidine
What this could lead to
If it works, this combination could help prevent cancer relapse in children after a stem cell transplant, improving survival.
What could go wrong
This is an early, small dose-finding study, so safety and effectiveness are not yet known. Side effects from the drugs may limit their use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion Criteria: 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. \-

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Conditions

The condition(s) this trial relates to.

acute biphenotypic leukemia acute myeloid leukemia juvenile myelomonocytic leukemia mixed phenotype acute leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia Juvenile myelomonocytic leukemia Mixed phenotype acute leukemia Myelodysplastic syndromes

Contacts and locations

Locations

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701, United States

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