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Tyrosine kinase inhibitor
Pevonedistat + Ibrutinib for CLL and Non-Hodgkin Lymphoma
Phase 1
Waitlist Available
Led By Alexey Danilov
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
Patients with CLL/SLL must demonstrate active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment
Patients with NHL and with B-cell prolymphocytic leukemia must have an indication for treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first study treatment until progression, start of anti-leukemic therapy, or death, assessed up to 4 years
Awards & highlights
Study Summary
This trial studies the side effects and best dose of pevonedistat when given with ibrutinib for people with CLL or NHL that has returned or stopped responding to other treatments.
Who is the study for?
This trial is for people with certain types of blood cancers like CLL or non-Hodgkin lymphoma that have not improved with other treatments. Participants must be in fairly good health, able to perform daily activities (ECOG 0-2), and meet specific lab criteria indicating their organs are functioning well. They should agree to use contraception and not donate eggs or sperm during the study.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs, Pevonedistat and Ibrutinib, to find out the safest doses and how they affect cancer cell growth. It's a phase I study which means it's early in the clinical trials process focusing on safety rather than effectiveness.See study design
What are the potential side effects?
Possible side effects include reactions related to blocking enzymes needed for cell growth which may affect normal cells as well as cancer cells. Specific side effects aren't listed but could range from mild symptoms like nausea to more serious issues affecting organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My CLL/SLL requires treatment based on specific health criteria.
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I have NHL or B-cell leukemia and need treatment.
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My cancer involves swollen lymph nodes or affects areas outside the lymph nodes, not including LPL or CLL.
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I can care for myself and am expected to live more than 3 months.
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I have had specific chemoimmunotherapy for my type of blood cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first study treatment until progression, start of anti-leukemic therapy, or death, assessed up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first study treatment until progression, start of anti-leukemic therapy, or death, assessed up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs), serious AEs (SAEs), dose interruptions, reductions and dose intensity Common Terminology Criteria for Adverse Events version 4.03
Incidence of dose limiting toxicities (DLTs)
Secondary outcome measures
Event-free survival (EFS)
Overall response rate (ORR) determined based on proportion of participants who achieve complete response (CR), with incomplete marrow recovery (CRi), partial response (PR), or nodular partial response (nPR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pevonedistat, ibrutinib)Experimental Treatment5 Interventions
Participants receive pevonedistat IV over 1 hour on days 1, 3, and 5, and ibrutinib PO daily on days 2-21 of course 1 and days 1-21 of subsequent courses. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Participants then receive only ibrutinib PO daily on days 1-21. Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Pevonedistat
2021
Completed Phase 2
~290
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,442 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,135 Total Patients Enrolled
Alexey DanilovPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot swallow or keep down oral medication.I have not taken certain medications or undergone specific therapies recently.I haven't taken strong CYP3A affecting drugs in the last 14 days.I have had cancer before, but it fits the exceptions.Your blood tests must show certain levels for bilirubin, AST/ALT, creatinine clearance, platelets, neutrophil count, albumin, and hemoglobin.I have a serious lung condition like COPD, lung scarring, or fibrosis.I have severe liver problems or cirrhosis.I will not donate eggs during the study or for 4 months after the last dose.My CLL/SLL requires treatment based on specific health criteria.I have NHL or B-cell leukemia and need treatment.My cancer involves swollen lymph nodes or affects areas outside the lymph nodes, not including LPL or CLL.My cancer has spread to my brain or spinal cord.I am on a full dose of blood thinners or have a bleeding disorder that is not under control.I will not donate sperm during the study or for 4 months after the last dose.I haven't had major surgery in the last 2 weeks and don't plan any during the study.I meet the specific requirements not to participate based on my gender.I have had a stem cell transplant and am experiencing complications.I can care for myself and am expected to live more than 3 months.I have had specific chemoimmunotherapy for my type of blood cancer.I have a known heart or lung condition.You cannot tolerate ibrutinib.I have been diagnosed with B-CLL or SLL based on specific tests.I do not have any severe or uncontrolled infections.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pevonedistat, 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.
How many participants are actively engaged in this investigation?
"This study is no longer recruiting participants. It was first made available on 3/22/2018 and the information was most recently updated on 5/9/2022. Currently, there are 3786 trials searching for leukemia patients as well as 170 studies seeking those with Pevonedistat-related issues."
Answered by AI
To what extent can the administration of Pevonedistat prove harmful?
"The safety of Pevonedistat is estimated to be a 1, as this Phase 1 trial has only provided limited data regarding the drug's efficacy and risk profile."
Answered by AI
Could you elaborate on the precedent clinical trials of Pevonedistat?
"Pevonedistat was initially evaluated in 2011 at the National Institute of Health Clinical Centre, 9000 Rockville Pike. Presently, there exist 704 completed studies with 170 experiments ongoing; a majority of these are taking place in Duarte, California."
Answered by AI
Are there any available slots in this trial for participants?
"According to the clinicaltrials.gov site, this medical experiment is not actively accepting participants at present. The trial was first publicized on March 22nd 2018 and was last modified on May 9th 2022. In spite of its inactivity, there are 3956 other studies currently recruiting patients for various treatments."
Answered by AI
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