← Back to Search

Bruton's Tyrosine Kinase (BTK) Inhibitor

Ixazomib + Ibrutinib for Mantle Cell Lymphoma (PrE0404 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by PrECOG, LLC.
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 phase i: 12 months; phase ii: 36 months
Awards & highlights

PrE0404 Trial Summary

This trial will test the combination of ixazomib and ibrutinib to treat mantle cell lymphoma that has relapsed or progressed despite treatment.

Who is the study for?
Adults with mantle cell lymphoma that has returned or didn't respond to treatment, who have tried at least one therapy before. They must not be on warfarin, have had recent surgery, or have allergies to study drugs. Participants need measurable disease and can't be pregnant or breastfeeding. They should agree to use contraception and cannot join if they've had certain other treatments recently or suffer from severe illnesses that could affect the trial.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: Ixazomib (a proteasome inhibitor) and Ibrutinib (already FDA-approved for MCL after one prior therapy). The goal is to see if adding Ixazomib improves outcomes in patients whose MCL has relapsed or is refractory when compared to just using Ibrutinib alone.See study design
What are the potential side effects?
Possible side effects include digestive issues, blood disorders, fatigue, allergic reactions related to infusion, liver problems indicated by changes in bilirubin levels, infections due to weakened immune system response, heart complications like arrhythmias or congestive heart failure symptoms worsening.

PrE0404 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase i: 12 months; phase ii: 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and phase i: 12 months; phase ii: 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Dose Limiting Toxicities (DLT) Rate
Phase II: Complete Response Rate
Secondary outcome measures
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Overall Response Rate (ORR)
Overall Survival (OS)
+1 more

PrE0404 Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase II: Ixazomib & BTK-NaiveExperimental Treatment2 Interventions
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Group II: Phase II: Ixazomib & BTK Pre-Treated (Closed 8/7/2020)Experimental Treatment2 Interventions
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Group III: Phase I: Ixazomib & IbrutinibExperimental Treatment2 Interventions
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
2017
Completed Phase 4
~3370
Ibrutinib
2014
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

PrECOG, LLC.Lead Sponsor
17 Previous Clinical Trials
7,415 Total Patients Enrolled
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,177,973 Total Patients Enrolled
Jonathon B Cohen, MDStudy ChairEmory University - Winship Cancer Institute

Media Library

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03323151 — Phase 1 & 2
Mantle Cell Lymphoma Research Study Groups: Phase I: Ixazomib & Ibrutinib, Phase II: Ixazomib & BTK-Naive, Phase II: Ixazomib & BTK Pre-Treated (Closed 8/7/2020)
Mantle Cell Lymphoma Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT03323151 — Phase 1 & 2
Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03323151 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has Ixazomib been examined in other medicinal experiments?

"Ixazomib was initially researched in 2011 at the National Institutes of Health Clinical Center, 9000 Rockville Pike. Out of all the trials completed thus far, 144 have been successfully concluded and 222 are currently active. A large majority of these experiments are being conducted out of Atlanta, Georgia."

Answered by AI

How many physical sites is this clinical trial currently administered at?

"This research project is enrolling participants from Winship Cancer Institute of Emory University (Atlanta, GA), Gundersen Health System (La Crosse, WI) and the University of Virginia in Charlottesville (VA). In addition to those sites, there are 13 other clinical trial centers."

Answered by AI

What is the current cohort size for this research project?

"At this time, enrolment for the trial has been suspended. First launched on August 13th 2018 and most recently updated November 17th 2022 - if you're seeking to join another study there are currently 1,720 clinical trials recruiting patients with lymphoma/mantle-cell and 222 studies accepting participants into Ixazomib investigations."

Answered by AI

What are the key aims of this investigation?

"Takeda, the trial sponsor, has reported that their primary outcome which will be monitored over a 1-year period is Phase I: Maximum Tolerated Dose (MTD). Supplementary assessments such as Overall Response Rate (ORR) and Progression-Free Survival (PFS), both measured according to Lugano classification criteria, and Overall Survival (OS) based on similar metrics are also being evaluated."

Answered by AI

Is this investigation currently recruiting participants?

"The data hosted on clinicaltrials.gov indicates that this particular trial is no longer recruiting new participants, with the initial posting date being August 13th 2018 and the most recent update occurring November 17th 2022. However, there are 1942 other trials presently seeking patients to take part in their research projects."

Answered by AI

What is the typical application of Ixazomib?

"Ixazomib has been proven to be an effective treatment option for patients with mantle cell lymphoma (MCL), Waldenstrom macroglobulinemia, and chronic lymphocytic leukemia (CLL)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma
2018. "A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03323151.
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top