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Histone Deacetylase Inhibitor
Panobinostat for Sickle Cell Disease (LBH589 Trial)
Phase 1
Recruiting
Led By Abdullah Kutlar, MD
Research Sponsored by Abdullah Kutlar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of homozygous SS or S-β0Thalassemia
- History of priapism requiring medical intervention within the past two years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 8, 15, 22, 29, 43, 57, 85, 113
Awards & highlights
LBH589 Trial Summary
This trial is testing a drug called panobinostat to see if it is safe and effective in treating adults with sickle cell disease. Panobinostat is a pan histone deacetylase (HDAC) inhibitor, which has been shown to increase hemoglobin F induction and inhibit cell-specific inflammation.
Who is the study for?
Adults over 18 with sickle cell disease who haven't responded well to or can't take hydroxyurea. They should have had at least two hospitalizations or three pain crises in the past year, or a history of other severe complications related to sickle cell disease. People with certain blood counts, organ dysfunctions, heart conditions, active infections like HIV/Hepatitis B/C, recent surgeries, and women who are pregnant/breastfeeding or not using contraception are excluded.Check my eligibility
What is being tested?
The trial is testing panobinostat's safety and effectiveness for adults with sickle cell disease. Panobinostat is an HDAC inhibitor that may increase hemoglobin F levels and reduce inflammation—both potentially beneficial for managing this condition.See study design
What are the potential side effects?
Panobinostat could cause side effects such as changes in blood counts leading to increased risk of infections or bleeding, nausea, fatigue, diarrhea, liver problems (elevated enzymes), electrolyte imbalances (like low calcium/magnesium/potassium), heart issues including abnormal rhythms and QT prolongation which can be serious.
LBH589 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with SS or S-β0 Thalassemia.
Select...
I have needed treatment for a prolonged erection in the last two years.
Select...
I cannot tolerate or have not responded to hydroxyurea treatment.
Select...
I've been hospitalized at least twice in the last year for sickle cell complications.
Select...
I've had 3 or more painful episodes in the last year needing hospital visits for strong painkillers.
Select...
I have had leg ulcers more than once.
Select...
I have had Acute Chest Syndrome in the last 5 years.
LBH589 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 8, 15, 22, 29, 43, 57, 85, 113
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 8, 15, 22, 29, 43, 57, 85, 113
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure
Secondary outcome measures
Define mechanisms of effect of panobinostat (Hb F induction and anti-inflammatory effects) and discover biomarkers of treatment response
Measure
Side effects data
From 2013 Phase 1 & 2 trial • 28 Patients • NCT0110531256%
Platelet count decreased
56%
Anemia
38%
Hypocalcemia
31%
Creatinine increased
31%
Electrocardiogram QT corrected interval prolonged
31%
White blood cell decreased
25%
Neutrophil count decreased
13%
Anorexia
13%
Fatigue
13%
Nausea
13%
Hypermagnesemia
6%
Hyperkalemia
6%
Hypophosphatemia
6%
Fracture
6%
Lung infection
6%
Weight loss
6%
Vomiting
6%
Edema limbs
6%
Alanine aminotransferase increased
6%
Diarrhea
6%
Glucose intolerance
6%
Blood bilirubin increased
6%
Dyspnea
6%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase II
Phase I: Dose Level One
Phase I: Dose Level Two
LBH589 Trial Design
1Treatment groups
Experimental Treatment
Group I: PanobinostatExperimental Treatment1 Intervention
All patients will receive Panobinostat at specified dose levels and dosing schedules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panobinostat
FDA approved
Find a Location
Who is running the clinical trial?
Secura Bio, Inc.Industry Sponsor
8 Previous Clinical Trials
230 Total Patients Enrolled
Abdullah KutlarLead Sponsor
Abdullah Kutlar, MDPrincipal InvestigatorAugusta University
1 Previous Clinical Trials
26 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that affects my heart's rhythm.I cannot stop or change my current medication for the study.I am 18 years old or older.I have been diagnosed with SS or S-β0 Thalassemia.I have needed treatment for a prolonged erection in the last two years.I cannot tolerate or have not responded to hydroxyurea treatment.I have severe sickle cell disease.I've been hospitalized at least twice in the last year for sickle cell complications.I have a heart condition or significant heart disease.My thyroid function is normal, possibly with medication.I haven't taken any medication that can increase fetal hemoglobin levels in the last 60 days.I've had a severe pain crisis needing injection medication in the last 2 weeks.I am not pregnant or breastfeeding and agree to use two forms of birth control if I'm of childbearing age.I have had a stroke but am not on regular blood transfusions.I do not have severe stomach or bowel problems that could affect medication absorption.I regularly receive blood transfusions or had one recently affecting my hemoglobin.I have stable atrial fibrillation and meet no other heart-related exclusions.I have not had a heart attack in the last 3 months.I do not have severe health issues like uncontrolled diabetes or serious lung problems.I had major surgery more than 2 weeks ago and have recovered from it.I have had episodes of very fast heartbeats.I have not had chest pain from heart disease in the last 3 months.I am not currently on a study drug nor have I been in the last 60 days.I've had 3 or more painful episodes in the last year needing hospital visits for strong painkillers.I haven't had cancer in the last 5 years, except for skin cancer or cervical cancer that hasn't spread.I have had leg ulcers more than once.I am a male and will use a condom with partners who can become pregnant, during and for 3 months after treatment.I have been diagnosed with HIV, Hepatitis B, or Hepatitis C.I have had Acute Chest Syndrome in the last 5 years.I do not have serious heart conditions like uncontrolled high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Panobinostat
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.
Are there still opportunities available to participate in this experiment?
"According to clinicaltrials.gov, this research has ceased participant recruitment; its posting dating back to 11/1/2010 and latest update on 5/26/2021. However, there are a multitude of other trials that potential patients can join at present."
Answered by AI
Is this novel research the first of its kind?
"Since 2010, Secura Bio, Inc. has led the research and clinical trial of panobinostat. Following successful Phase 1 testing with 18 patients in that same year, 14 studies are now conducted worldwide across 95 cities and 32 nations."
Answered by AI
Are there any prior studies involving the utilization of panobinostat?
"Today, there are 14 ongoing clinical studies involving panobinostat. None of these have progressed to Phase 3 yet. The majority of these trials take place in New york City though a total of 201 sites across the nation are participating."
Answered by AI
How many people are enrolled in this research project at its maximum capacity?
"Unfortunately, this trial is not currently accepting any more patients. The original post was published on November 1st 2010 and the most recent edit was made on May 26th 2021. If you are searching for other studies related to anemia, sickle cell or panobinostat, then there are 197 active trials and 14 recruiting participants respectively."
Answered by AI
Has the FDA ratified panobinostat as a viable therapy?
"Considering the limited clinical evidence available for both safety and efficacy, our team at Power assigned panobinostat a score of 1."
Answered by AI
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