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Vorinostat + Azacitidine for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Cassandra Josephson, MD
Research Sponsored by Johns Hopkins All Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patient with infant(s) agrees not to breastfeed her infant(s) while on study
Patient is 1 year to 21 years of age
Must not have
Concomitant use of coumarin-derived anticoagulants or valproic acid
Patient has chronic myelogenous leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing a combination of drugs to see if it can help prevent relapse in children with myeloid malignancies who have undergone allogeneic hematopoietic cell transplantation.

Who is the study for?
This trial is for children and young adults aged 1 to 21 with certain myeloid malignancies who've had a stem cell transplant. They must understand the study, not be breastfeeding or pregnant, use contraception, and can't be on other leukemia treatments or have chronic myelogenous leukemia.
What is being tested?
The study tests increasing doses of Vorinostat combined with low-dose Azacitidine after stem cell transplants in young patients to prevent cancer relapse. The goal is to find the highest dose that's safe without causing severe side effects.
What are the potential side effects?
Potential side effects include allergic reactions to the drugs being tested (Vorinostat or Azacitidine), complications from combining these drugs with anticoagulants like warfarin, or mood changes if taking valproic acid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree not to breastfeed while participating in the study.
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I am between 1 and 21 years old.
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I have had a stem cell transplant from a donor.
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I (or my guardian) understand the study's risks and benefits and can sign consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking blood thinners or valproic acid.
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I have chronic myelogenous leukemia.
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I am scheduled for chemotherapy, radiation, or immunotherapy during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD)
Secondary study objectives
Dose-limiting toxicities
GVHD
Immune recovery
+2 more

Side effects data

From 2011 Phase 3 trial • 661 Patients • NCT00128102
57%
Nausea
47%
Fatigue
43%
Diarrhoea
40%
Vomiting
40%
Decreased appetite
29%
Dyspnoea
24%
Constipation
20%
Weight decreased
18%
Tumour pain
18%
Cough
15%
Pleural mesothelioma malignant advanced
14%
Anaemia
12%
Pyrexia
9%
Insomnia
9%
Dry mouth
9%
Blood creatinine increased
9%
Abdominal pain
8%
Back pain
8%
Dysgeusia
7%
Oedema peripheral
7%
Dizziness
7%
Thrombocytopenia
7%
Headache
6%
C-reactive protein increased
6%
Dehydration
6%
Musculoskeletal pain
5%
Malaise
4%
Pneumonia
4%
Anxiety
3%
Rash
2%
Atrial fibrillation
2%
Accidental overdose
2%
Pleural effusion
1%
Overdose
1%
Sepsis
1%
Pneumothorax
1%
Confusional state
1%
Bladder cancer
1%
General physical health deterioration
1%
Non-cardiac chest pain
1%
Pericarditis
1%
Disseminated intravascular coagulation
1%
Death
1%
Ascites
1%
Dysphagia
1%
Pulmonary embolism
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorinostat
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combined therapyExperimental Treatment2 Interventions
Patients will be enrolled in blocks of 3, with vorinostat dose-escalation according to 3+3 study design. Low-dose azacitidine will be administered in a fixed dose to all patients, for days 1-5 of each 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Vorinostat
FDA approved

Find a Location

Who is running the clinical trial?

Johns Hopkins All Children's HospitalLead Sponsor
45 Previous Clinical Trials
5,008,421 Total Patients Enrolled
Cassandra Josephson, MDPrincipal InvestigatorJohns Hopkins All Children's Hospital
6 Previous Clinical Trials
2,448 Total Patients Enrolled
Benjamin Oshrine, MDPrincipal Investigator - Johns Hopkins All Children's Hospital
Johns Hopkins All Children's Hospital
1 Previous Clinical Trials
218 Total Patients Enrolled

Media Library

Vorinostat Clinical Trial Eligibility Overview. Trial Name: NCT03843528 — Phase 1
Myelomonocytic Leukemia Research Study Groups: Combined therapy
Myelomonocytic Leukemia Clinical Trial 2023: Vorinostat Highlights & Side Effects. Trial Name: NCT03843528 — Phase 1
Vorinostat 2023 Treatment Timeline for Medical Study. Trial Name: NCT03843528 — Phase 1
~2 spots leftby Jul 2025
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