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Ixazomib + Rituximab for Mantle Cell Lymphoma
Phase 1 & 2
Waitlist Available
Led By Jonathon Cohen, MD, MS
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Are surgically sterile, OR
- t(11;14) detected by fluorescence in situ hybridization (FISH), conventional cytogenetics, or other molecular evaluation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing ixazomib given with rituximab after stem cell transplant to see how well it works and what the side effects are.
Who is the study for?
This trial is for patients with Mantle Cell Lymphoma in remission after a stem cell transplant. They must have good organ function, no recent chemotherapy or radiation, and no uncontrolled illnesses. Women should not be pregnant and participants must agree to use effective contraception.Check my eligibility
What is being tested?
The trial tests the combination of Ixazomib (an enzyme blocker) and Rituximab (a monoclonal antibody) post-stem cell transplant to prevent cancer recurrence. It aims to determine the best dose of Ixazomib while assessing how well both drugs work together.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation by Rituximab, such as fever or chills, and effects from Ixazomib like gastrointestinal issues or skin rash. Organ inflammation and blood disorders may also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am surgically sterile.
Select...
My cancer has a specific genetic feature known as t(11;14).
Select...
I have been postmenopausal for at least one year.
Select...
My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.
Select...
My cancer cells show cyclin D1 presence.
Select...
I completed a stem cell transplant after my first cancer treatment without relapsing before the transplant.
Select...
My diagnosis of mantle cell lymphoma has been confirmed.
Select...
My condition hasn't worsened since my transplant.
Select...
I can take care of myself and am up and about more than half of my waking hours.
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
Progression-free survival (PFS), defined as the percentage of patients who have received at least one dose of study therapy who are alive and free of disease progression or relapse at 1-year post autologous stem cell transplant (Phase II)
Recommended phase 2 dose of ixazomib, defined as the dose where 1 or fewer of 6 treated patients experience a dose limiting toxicity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Phase I)
Secondary outcome measures
Conversion rate from MRD positive to MRD negative during therapy (Phase I & II)
Incidence of adverse events graded according to CTCAE version 4.03 (Phase I & II)
Median OS (Phase II)
+6 moreOther outcome measures
Median OS for patients who have a pre-transplant PET/CT (Phase II)
Median PFS for patients who have a pre-transplant PET/CT (Phase II)
PFS for patients who have a pre-transplant PET/CT (Phase II)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ixazomib, rituximab)Experimental Treatment2 Interventions
Beginning between 70-180 days after stem cell transplant, patients receive ixazomib PO on days 1, 8, and 15, and rituximab IV (or SC after first dose if deemed appropriate) on day 1 of courses 1, 3, 5, 7, and 9. Treatment repeats every 28 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
Rituximab
FDA approved
Ixazomib
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,359 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,507,274 Total Patients Enrolled
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,890 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiotherapy in the last 14 days, or if it was a small area, in the last 7 days.I haven't needed IV antibiotics or had a serious infection in the last 14 days.I am not pregnant or breastfeeding.I am a male and agree to follow the birth control requirements.I don't have GI issues that affect medicine absorption or swallowing.My heart condition has been stable for at least 60 days.I do not have an active infection, including hepatitis B or C, or HIV.I have severe nerve damage in my hands or feet, or moderate with pain.I haven't been on any other clinical trials for 30 days.I have not relapsed or worsened since starting my initial cancer treatment.I am surgically sterile.I can start treatment between day 70 and 180, depending on my blood test results.I haven't had cancer, except for certain skin, cervical, or low-risk prostate cancers, in the last 2 years.I agree to practice true abstinence as a form of contraception.My cancer has a specific genetic feature known as t(11;14).My blood tests show enough neutrophils and platelets, and I haven't had a platelet transfusion in the last 3 days.I have been postmenopausal for at least one year.I have mostly recovered from my last chemotherapy, with only minor side effects remaining.I have not been treated with ixazomib, but I may have received bortezomib.My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.My cancer cells show cyclin D1 presence.I have had lymphoma in my brain or spinal cord but no active disease after initial treatment.I completed a stem cell transplant after my first cancer treatment without relapsing before the transplant.I agree to practice true abstinence as a form of contraception.I haven't taken specific strong medications or St. John's wort in the last 14 days.My diagnosis of mantle cell lymphoma has been confirmed.My condition hasn't worsened since my transplant.I am a female patient.I have not had major surgery in the last 14 days.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ixazomib, rituximab)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions can Rituximab be utilized to mitigate?
"Rituximab is a popular therapeutic treatment for diffuse large b-cell lymphoma (dlbcl) and can also be utilized to manage other conditions such as polyangium, pemphigus vulgaris, and multiple different types of B-Cell lymphomas."
Answered by AI
How many individuals are involved in this experiment?
"As it stands, this clinical trial is not accepting participants. Its initial posting dates back to March 1st 2016 and its last edit was made on October 26th 2021. If you are searching for new opportunities, there are currently 1720 distinct trials related to lymphoma, mantle-cell seeking enrolment as well as 471 Rituximab trials actively recruiting patients."
Answered by AI
Are there currently any vacancies available in this clinical research project?
"As per the clinicaltrials.gov database, it appears that this medical trial is not accepting participants at this time. The first posting of the study was on March 1st 2016 and most recently updated on October 26th 2021. Unfortunately, no more applicants are being accepted for enrollment; however, there are 2191 other trials actively searching for patients as we speak."
Answered by AI
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