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Vorinostat + Azacitidine for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Benjamin Oshrine, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I (or my guardian) understand the study's risks and benefits and can sign consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Dose-limiting toxicities
GVHD
Immune recovery
+2 moreSide effects data
From 2011 Phase 3 trial • 661 Patients • NCT0012810257%
Nausea
47%
Fatigue
43%
Diarrhoea
40%
Decreased appetite
40%
Vomiting
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%
Dizziness
7%
Oedema peripheral
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%
Sepsis
1%
Overdose
1%
Bladder cancer
1%
Pneumothorax
1%
Non-cardiac chest pain
1%
Confusional state
1%
General physical health deterioration
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
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
Vorinostat
FDA approved
Azacitidine
FDA approved
Find a Location
Who is running the clinical trial?
Johns Hopkins All Children's HospitalLead Sponsor
43 Previous Clinical Trials
5,007,524 Total Patients Enrolled
Benjamin Oshrine, MDPrincipal Investigator - Johns Hopkins All Children's Hospital
Johns Hopkins All Children's Hospital
1 Previous Clinical Trials
292 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking blood thinners or valproic acid.I agree not to breastfeed while participating in the study.I am between 1 and 21 years old.I have chronic myelogenous leukemia.I am part of a clinical trial for new post-transplant medications.I am scheduled for chemotherapy, radiation, or immunotherapy during the study.I am a woman able to have children and my pregnancy test is negative.I have had a stem cell transplant from a donor.I have been diagnosed with a specific type of blood cancer and may have received certain treatments before a stem cell transplant.I agree to use effective birth control during the study.I (or my guardian) understand the study's risks and benefits and can sign consent.You are allergic to azacitidine or vorinostat.
Research Study Groups:
This trial has the following groups:- Group 1: Combined therapy
Awards:
This trial has 3 awards, including:- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the participant in this research need to meet a minimum age requirement?
"This study seeks participants that are between the age of one year to twenty-one years. Currently, there is a total of 486 clinical trials involving those under eighteen while 1517 involve patients over sixty-five."
Answered by AI
Is my eligibility compatible with the qualifications of this medical trial?
"This trial is seeking to enroll 15 people with myelodysplastic syndromes aged between 1 and 21."
Answered by AI
How likely are adverse effects for those taking Vorinostat?
"The safety of Vorinostat is judged to be a 1 due its Phase 1 status, meaning that information on the drug's effectiveness and adverse effects are limited."
Answered by AI
Are there any open slots for participants in this scientific investigation?
"As indicated on clinicaltrials.gov, this medical study is actively enrolling patients and has been open since May 1st 2019 with the most recent update occuring August 11th 2022."
Answered by AI
What is the size of the participant pool currently engaged in this research project?
"Affirmative. According to information posted on clinicaltrials.gov, this current medical research project is actively recruiting participants who meet the criteria; it was initiated on May 1st 2019 and its parameters were most recently revised on August 11th 2022. The study will include 15 members from a single site."
Answered by AI
Has Vorinostat been tested in other scientific trials?
"Currently, Vorinostat is the subject of 202 ongoing studies with 34 in Phase 3. While St Louis, Missouri has a notable concentration of such trials, there are 6157 other medical centres engaging in research on this drug."
Answered by AI
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