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Histone deacetylase inhibitor
Pevonedistat + Belinostat for Acute Myeloid Leukemia or Myelodysplastic Syndrome
Phase 1
Waitlist Available
Led By Steven Grant
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
If evidence of chronic HBV infection, HBV viral load must be undetectable on suppressive therapy, if indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing pevonedistat and belinostat to see if they help leukemia or myelodysplastic syndrome that has come back or does not respond to treatment.
Who is the study for?
This trial is for adults with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), who have tried at least one treatment before. They should not have a history of certain diseases, like AIDS or active hepatitis, and must be generally healthy with an ECOG performance status of <=2. Participants need to use effective contraception and understand the study's consent.Check my eligibility
What is being tested?
The trial is testing the combination of two chemotherapy drugs, Pevonedistat and Belinostat, to determine their safety and optimal dosages in patients whose AML or MDS has returned after treatment or did not respond to previous treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system, liver problems indicated by changes in blood tests, fatigue, nausea, vomiting, diarrhea, increased risk of infection due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My chronic hepatitis B is under control with undetectable viral load.
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I am HIV positive with a good immune status, controlled virus, and no severe infections.
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My kidney function, measured by creatinine clearance or GFR, is within the normal range.
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I can take care of myself but may not be able to do active work.
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My MDS is classified as intermediate-2 or high risk.
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I have AML, but not the APL type.
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My AML has not responded or has returned after treatment.
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My MDS is high risk and I didn't respond well to a previous treatment with a DNA-targeting drug.
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My kidney function, measured by creatinine clearance or GFR, is within the normal range.
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My condition did not improve after treatment with a specific type of medication.
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My AML has returned or didn't respond after at least one treatment.
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I had hepatitis C but have been treated and now have no detectable virus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase 2 dose (RP2D) for the combination of MLN4924 (pevonedistat) and belinostat
Secondary outcome measures
Change in MLN4924 (pevonedistat) and belinostat plasma concentrations
Change in candidate biomarker levels in bone marrow and/or blood samples
Duration of response
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (belinostat, pevonedistat)Experimental Treatment2 Interventions
Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belinostat
2006
Completed Phase 2
~430
Pevonedistat
2021
Completed Phase 2
~290
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,123 Total Patients Enrolled
Steven GrantPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
3 Previous Clinical Trials
158 Total Patients Enrolled
Keri R MaherPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diagnosed heart condition known as long QT syndrome.I can take care of myself but might not be able to do heavy physical work.My chronic hepatitis B is under control with undetectable viral load.I will not donate sperm during the study or for 4 months after the last dose.I will not donate eggs during the study or for 4 months after the last dose.I have leukemia that has spread to my brain.Your bilirubin levels should be within the normal range unless you have Gilbert's syndrome. If you have Gilbert's syndrome, your direct bilirubin levels should not be more than 1.5 times the upper limit of normal for the laboratory.I am HIV positive with a good immune status, controlled virus, and no severe infections.My condition is acute promyelocytic leukemia (APL).My kidney function, measured by creatinine clearance or GFR, is within the normal range.I have a bleeding disorder that is not under control.I can take care of myself but may not be able to do active work.I don't have severe side effects from past treatments, except for those from hydroxyurea.I can understand and am willing to sign the consent form. If I have a decision-making impairment, I have someone to help.You have no detectable viruses in your body.I do not have any uncontrolled illnesses or infections.I am taking or will take strong UGT1A1 inhibitors.I haven't taken any strong enzyme inducers in the last 14 days.I have a serious lung condition like COPD, lung scarring, or fibrosis.I have no other cancers except for certain treated ones or those I've been free from for a year.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.I have a stomach or intestine condition that affects medication absorption.I have a UGT1A gene variation.I have a serious irregular heartbeat.I am allergic to medications similar to MLN4924 or belinostat.The level of AST and ALT in your blood must not be more than three times the normal limit set by the hospital.I have had a stem cell transplant within the last 3 months.My heart's electrical cycle is longer than normal.I haven't had cancer treatment, except hydroxyurea, in the last 14 days.My MDS is classified as intermediate-2 or high risk.I have been diagnosed with liver cirrhosis.I have AML, but not the APL type.My AML has not responded or has returned after treatment.I have been treated with belinostat or MLN4924 before.My MDS is high risk and I didn't respond well to a previous treatment with a DNA-targeting drug.My kidney function, measured by creatinine clearance or GFR, is within the normal range.My condition did not improve after treatment with a specific type of medication.My AML has returned or didn't respond after at least one treatment.I am a candidate for a stem cell transplant that could potentially cure me.Your CD4 count, a measure of immune system health, should be over 350 cells per cubic millimeter of blood.I had hepatitis C but have been treated and now have no detectable virus.I have symptoms or signs of blood flow blockage or abnormal blood clotting.I do not have serious heart or lung conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (belinostat, pevonedistat)
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.
How many participants has this research accommodated?
"Unfortunately, this trial has ended its recruitment phase and is no longer accepting applicants. The opening was on February 28th 2019 while the latest edit occurred November 18th 2022. For those searching for other studies, there are 3683 trials actively looking for patients with leukemia or myeloid acute diseases; likewise, 23 Pevonedistat-related clinical trials have open positions to fill."
Answered by AI
Is this clinical trial in the process of recruiting participants?
"As reported on clinicaltrials.gov, this medical trial is no longer admitting participants at present; it was initially published on February 28th 2019 and last edited November 18th 2022. Fortunately, there are 3706 other trials now open for enrollment."
Answered by AI
Has Pevonedistat been investigated in other research efforts?
"First studied in 2016 at the University of Cincinnati Medical Center, pevonedistat has since been researched extensively; with 43 studies concluded and 23 more presently recruiting participants. A significant number of these experiments are conducted within Tampa, Florida."
Answered by AI
At how many sites is the trial presently being conducted?
"There are 6 designated sites participating in this trial, such as the Moffitt Cancer Center - McKinley Campus located in Tampa and Virginia Commonwealth University/Massey Cancer Center found in Richmond. Additionally, there are other locations including Rutgers Cancer Institute of New jersey based in New Brunswick."
Answered by AI
Is Pevonedistat safe to use for human consumption?
"Our experts at Power scored pevonedistat a 1, as this trial is only in its first phase of testing. Hence, safety and efficacy data are still limited."
Answered by AI
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