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Histone Deacetylase Inhibitor
Abexinostat + Ibrutinib for Lymphoma
Phase 1
Waitlist Available
Led By Gottfried von Keudell, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Allogeneic stem cell transplant recipients be greater than 6 months post transplant, not on immunosuppression for prevention of graft versus host disease for >3 months and without active graft versus host disease
For patients with documented bone marrow involvement of underlying MCL or DLBCL at time of study enrollment, Hgb must be ≥ 8.0 g/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test the safety of abexinostat, given at different doses, to see if it can work with ibrutinib to stop cancer growth.
Who is the study for?
Adults with certain types of lymphoma (Diffuse Large B-cell or Mantle Cell) who've had at least one prior treatment and are not eligible for a stem cell transplant. They must have measurable cancer, be in relatively good health, able to take oral meds, and agree to birth control measures. Excludes those with recent major surgery, active infections like hepatitis C/B, other cancers within 5 years except specific non-threatening types, uncontrolled heart conditions, or if they've been treated with similar drugs before.Check my eligibility
What is being tested?
The trial is testing the safety of different doses of abexinostat combined with ibrutinib to see if this combination can halt the growth of Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma. The goal is to determine the best dose that works effectively without causing too many side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system suppression such as increased risk of infection, liver problems indicated by changes in blood tests for liver function, bleeding issues due to low platelet counts or other clotting disorders. There may also be gastrointestinal disturbances affecting how well patients absorb their medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stem cell transplant over 6 months ago, am not on recent immunosuppression, and don't have active graft versus host disease.
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My hemoglobin level is at least 8.0 g/dL despite having bone marrow cancer involvement.
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I have diffuse large B-cell lymphoma and have tried at least one treatment or cannot undergo a stem cell transplant.
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My potassium levels are normal, with or without supplements.
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My blood counts and organ functions are within the required ranges for the study.
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My platelet count is above 75,000 without transfusions, despite my bone marrow cancer.
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I can swallow and keep down pills.
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I have been diagnosed with either mantle cell lymphoma or diffuse large B cell lymphoma.
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I can take care of myself and perform daily activities.
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I have mantle cell lymphoma and have undergone at least one treatment.
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My lymphoma is a specific type that does not originate from the germinal center.
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I have had a stem cell transplant and no longer need blood transfusions.
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I am 18 years old or older.
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My lymphoma is a specific type that does not originate from the germinal center.
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
the MTD of abexinostat when combined with ibrutinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Abexinostat and IbrutinibExperimental Treatment2 Interventions
The investigational agents to be used in this study are ibrutinib and abexinostat. Ibrutinib will be administered once daily on a 28-day cycle. Abexinostat will be administered orally twice daily (approximately 4-6 hours apart) for 7 days a week given every other week on a 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abexinostat
2018
Completed Phase 1
~40
Ibrutinib
2014
Completed Phase 3
~1880
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,795 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,503 Total Patients Enrolled
Xynomic Pharmaceuticals, Inc.Industry Sponsor
10 Previous Clinical Trials
1,194 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been tested for Hepatitis B and do not have an active infection.I have been treated with ibrutinib or an HDAC inhibitor before.I had a stem cell transplant over 6 months ago, am not on recent immunosuppression, and don't have active graft versus host disease.I am currently on blood thinners like warfarin.I can follow the study's schedule and requirements.I still experience side effects from cancer treatment, except for hair loss.My hemoglobin level is at least 8.0 g/dL despite having bone marrow cancer involvement.I have diffuse large B-cell lymphoma and have tried at least one treatment or cannot undergo a stem cell transplant.My potassium levels are normal, with or without supplements.I have not received any live vaccines in the last 4 weeks.I have or had hepatitis B or C.My bone marrow and organs are functioning well.I have a GI condition that could affect how my body absorbs medication.I have severe liver disease.I am using or willing to use effective birth control during and after the study.My cancer has spread to my brain or its coverings.I haven't had chemotherapy or radiotherapy in the last 2 weeks.I am currently using other cancer treatment drugs.My lymphoma started as a less aggressive type and has become more severe.My blood counts and organ functions are within the required ranges for the study.I am not pregnant or breastfeeding.My platelet count is above 75,000 without transfusions, despite my bone marrow cancer.I am currently experiencing symptoms of graft versus host disease.I have another active cancer besides the one being treated.I can swallow and keep down pills.I have HIV or an uncontrolled infection.I do not have active Hepatitis C.I am on long-term steroids or immunosuppressants, not exceeding 10mg of prednisone daily.I need ongoing treatment with certain strong medications that cannot be stopped or changed before starting the study drug.I have been diagnosed with either mantle cell lymphoma or diffuse large B cell lymphoma.I can take care of myself and perform daily activities.I had cancer treated with the goal of cure and am expected to live 5 more years or have been cancer-free for 3 years.I have mantle cell lymphoma and have undergone at least one treatment.My lymphoma is a specific type that does not originate from the germinal center.I do not have serious heart problems or recent heart attacks.I do not have any severe illnesses that could affect my safety or interfere with the study.I had major surgery or an unhealed wound less than 4 weeks ago.I have had a stem cell transplant and no longer need blood transfusions.My cancer started as a less aggressive B-cell lymphoma but has now become more severe.I am 18 years old or older.I have diffuse large B-cell lymphoma and have tried at least one treatment or cannot undergo a stem cell transplant.I am using or willing to use effective birth control during and after the study.I had a stroke or brain bleed less than 6 months ago.My lymphoma is a specific type that does not originate from the germinal center.I have a bleeding disorder such as von Willebrand's disease or hemophilia.I agree not to donate sperm or eggs during and for 12 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Abexinostat and Ibrutinib
Awards:
This trial has 1 awards, including:- 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.
In what geographic locations can this experiment be found?
"Nine medical centres are conducting this trial, with three of them being Memorial Sloan Kettering Monmouth in Middletown and Commack, as well as Memoral Sloan Kettering Basking Ridge in Harrison. Additionally, there are 6 other institutions involved."
Answered by AI
Is the enrollment process for this research endeavor currently open?
"Unfortunately, this clinical trial has closed its recruitment phase and is no longer considering new applicants. It was first posted on May 29th 2019 and had a final edit date of August 11th 2022. If you are searching for alternatives, there are 1,767 studies actively looking for lymphoma B-cell participants as well as 162 trials recruiting patients to assess Abexinostat's efficacy."
Answered by AI
Has Abexinostat been the focus of prior clinical investigations?
"Since its first trial at the National Institutes of Health Clinical Center in 2011, abexinostat has been studied 101 times with 162 active trials. The majority of these studies take place within Middletown, New york."
Answered by AI
What is the approximate number of participants for this clinical experiment?
"At this moment, no patients are being admitted to the clinical trial mentioned. Initially posted on May 29th 2019 and most recently updated August 11th 2022, it is currently inactive. However, those looking for other trials have 1767 options available which involve lymphoma or B-cell research in addition to 162 studies actively admitting participants that investigate Abexinostat."
Answered by AI
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