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Anti-metabolites
Pevonedistat + Chemotherapy for Acute Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Led By Kevin Kelly, MD
Research Sponsored by University of Southern California
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 and/or other performance status 0-2
Patients with previously untreated AML (except acute promyelocytic leukemia [APL]) who meet specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing pevonedistat, a drug that may stop the growth of cancer cells, in combination with cytarabine and idarubicin, drugs that work in different ways to stop the growth of cancer cells.
Who is the study for?
This trial is for adults with acute myeloid leukemia (AML) who are fit for chemotherapy, have certain genetic features or a history of myelodysplastic syndrome, and haven't had AML treatment. Participants must be able to perform daily activities with minimal assistance (ECOG 0-2), have adequate organ function, agree to use contraception if they can have children, and not expect other serious health issues within the next 3 months.Check my eligibility
What is being tested?
The study tests pevonedistat combined with cytarabine and idarubicin in treating AML. Pevonedistat may block enzymes that cancer cells need to grow. Cytarabine and idarubicin are chemotherapy drugs that kill or stop cancer cells from dividing. The trial aims to find the best dose of pevonedistat and see how well this combination works.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems. Heart complications might occur due to pre-existing conditions or drug interactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
Select...
I have AML (not APL) and haven't received treatment for it.
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
Composite complete response rate
Incidence of adverse events (Phase Ib)
Secondary outcome measures
Relapse-free survival (RFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (idarubicin, cytarabine, pevonedistat)Experimental Treatment5 Interventions
INDUCTION: Patients receive idarubicin IV over 10-15 minutes on days 1-3, cytarabine IV over 1-3 hours on days 1-7, and pevonedistat IV over 60 minutes on days 1, 3, and 5. Patients with gross residual disease on day 14 bone marrow may receive a second course of induction chemotherapy.
CONSOLIDATION: Patients who achieve CR and will not undergo bone marrow transplant receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28-35 days for 4 courses in the absence of disease progression or unaccepted toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Pevonedistat
Not yet FDA approved
Idarubicin
FDA approved
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,225 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,614 Total Patients Enrolled
Kevin Kelly, MDPrincipal InvestigatorUniversity of Southern California
2 Previous Clinical Trials
74 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe liver problems or cirrhosis.I haven't had cancer treatment or radiation in the last 14 days.I haven't taken any strong enzyme inducers in the last 14 days.I refuse blood products or am allergic to them.I will not donate eggs during the study or for 4 months after the last dose.I am not pregnant, breastfeeding, or lactating.I agree to use effective contraception or practice abstinence during and for 4 months after the study.I can take care of myself and perform daily activities.I haven't had or been treated for another cancer within the last 2 years.I do not have a bleeding disorder that is currently uncontrolled.I am HIV positive.I am a woman who cannot become pregnant or will use two forms of birth control during the study.I have received chemotherapy for acute myeloid leukemia.My cancer has spread to my brain or spinal cord.I will not donate sperm during the study or for 4 months after the last dose.I have a known heart or lung condition.I have a serious lung condition like COPD, lung scarring, or fibrosis.I do not have any severe or uncontrolled infections.My hemoglobin is above 8 g/dL, possibly after a transfusion.I have AML (not APL) and haven't received treatment for it.I do not have any serious health or mental conditions that could stop me from completing the study.I haven't had major surgery in the last 14 days and don't plan any during the study.I do not have a life-threatening illness unrelated to my cancer.I am allergic to cytarabine or anthracyclines.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (idarubicin, cytarabine, pevonedistat)
Awards:
This trial has 2 awards, including:- 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 slots open for new volunteers for this research project?
"Unfortunately, this trial is not presently enrolling patients. The listing was created on April 18th, 2018 and updated as recently as August 5th, 2022. However, there are 1664 other trials for preleukemia and 268 studies involving Pevonedistat that are currently looking for participants."
Answered by AI
What conditions does Pevonedistat help alleviate?
"Pevonedistat is most commonly used for treatment of leptomeningeal metastases. It can also be taken to treat other conditions including acute promyelocytic leukemia, meningeal leukemia, acute myeloid leukemia, and pediatric cancers."
Answered by AI
How many enrollees are in this clinical trial?
"As of right now, this particular trial is not seeking any more participants. It was initially posted on April 18th, 2018 and the most recent update was on August 5th, 2022. There are 1664 other trials for preleukemia that are still recruiting patients and 268 active trials for Pevonedistat if you are interested in exploring other options."
Answered by AI
Does Pevonedistat have a history of being tested in other medical trials?
"As of now, there are 268 ongoing studies for Pevonedistat. Out of these, 64 are in Phase 3. Most investigations for Pevonedistat take place in Providence, Rhode island; however, there are 10399 total locations running trials for this medication."
Answered by AI
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