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DNA Methyltransferase Inhibitor
Pevonedistat + Decitabine for Acute Myeloid Leukemia
Phase 1
Waitlist Available
Led By Guido Marcucci
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing pevonedistat + decitabine to treat patients with high risk acute myeloid leukemia. This may stop cancer cell growth by blocking enzymes needed for cell growth.
Who is the study for?
This trial is for adults aged 60 or older with high-risk acute myeloid leukemia (AML), either newly diagnosed, untreated and not candidates for standard chemotherapy, or those with relapsed/refractory disease. It includes younger AML patients unfit for stem cell transplant. Participants must have a life expectancy over 6 months, be able to perform daily activities (ECOG <=2), and use effective contraception if of childbearing potential.
What is being tested?
The study is testing the combination of two drugs: pevonedistat and decitabine, to determine their safety and optimal dosages in treating high-risk AML. The goal is to see if these drugs can halt cancer growth by inhibiting enzymes necessary for cell proliferation.
What are the potential side effects?
Potential side effects from pevonedistat and decitabine may include fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, liver issues, kidney function changes, and possible allergic reactions.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose limiting toxicities (DLT) defined as any toxicities that are at least possibly related to pevonedistat that occur during cycle 1 assessed by NCI CTCAE version 4.03
Incidence of adverse effect assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Maximum tolerated dose (MTD) based on assessment of DLT
Secondary study objectives
Complete remission (CR) rate assessed by International Working Group criteria
Overall response rate (ORR) (CR + incomplete CR [CRi]) assessed by International Working Group criteria
Other study objectives
NF-kappaB activity
Nuclear NF-kappaB expression
Side effects data
From 2021 Phase 1 & 2 trial • 24 Patients • NCT0301035833%
Infusion Related Reaction
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
17%
Sinusitis
17%
Tumor Lysis Syndrome
17%
Interoperative Hemorrhage
17%
Platelet count decreased
17%
Febrile neutropenia
17%
Infusion related reaction
17%
Upper respiratory infection
17%
Otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1, Dose 1 (400 mg Entospletinib Daily)
Phase 2 and MTD (800 mg Entospletinib Daily)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pevonedistat, decitabine)Experimental Treatment4 Interventions
Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5 and decitabine IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unexpected toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Pevonedistat
2021
Completed Phase 3
~770
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
599 Previous Clinical Trials
1,923,512 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,012,002 Total Patients Enrolled
Guido MarcucciPrincipal InvestigatorCity of Hope Medical Center
7 Previous Clinical Trials
715 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have any other active cancer except for certain types that have been cured or treated a long time ago.You have a serious medical or mental health condition that could affect your ability to participate in the study.You have not taken any experimental medications within the 2 weeks before starting the study.You have a condition where the disease has spread to your brain or spinal cord.You are 60 years or older and your disease has come back or is not responding to treatment.If you have cancer cells that have spread outside of your bone marrow, you may still be eligible for the study if you meet other criteria.You have other medical conditions, but they are not expected to shorten your life expectancy within the next six months.You should be able to perform daily activities without assistance.You are a young patient with acute myeloid leukemia that has come back or is not responding to treatment, and you cannot receive a stem cell transplant.Women who can have children and men must use effective birth control methods or abstain from sex during the study and for 4 months after it ends, because it is not known how the study drugs may affect a developing fetus. If a woman becomes pregnant or thinks she might be pregnant while in the study, she should tell her doctor right away.You are 60 years or older and have recently been diagnosed with a condition that requires chemotherapy. However, you do not want to undergo the standard treatment of cytarabine/anthracyclines or are not eligible for it.If you have sex and it is part of your regular lifestyle, you must use a reliable form of birth control. Avoiding sex during certain times or using less reliable methods like withdrawal or spermicides are not acceptable forms of birth control.You may have had a bone marrow transplant for leukemia or other diseases.You can take hydroxyurea to control your blood count before and during the first cycle of treatment, but not after that.You are a younger adult with a certain type of high-risk disease that requires aggressive treatment with chemotherapy and/or a stem cell transplant, but you do not want to or cannot undergo these treatments.You are either postmenopausal for at least a year, have had a surgical procedure to prevent pregnancy, or are not currently pregnant but have the ability to become pregnant.You can have had any number of previous chemotherapy treatments.You have a serious illness that is not related to cancer and could be life-threatening.I'm sorry, but the criterion you provided is incomplete. Can you please provide me with more details so that I can summarize it for you?You are currently breastfeeding or pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pevonedistat, decitabine)
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.
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