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Alkylating agents
Chemotherapy + Rituximab + Ixazomib for Non-Hodgkin's Lymphoma
Phase 1 & 2
Waitlist Available
Led By Barbara Pro, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a histological diagnosis of Diffuse large B-cell lymphoma (DLBCL), B-cell lymphoma unclassifiable with features intermediate between diffuse large B-cell lymphoma, Burkitt lymphoma, or MYC+ plasmablastic lymphoma
Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a new drug, ixazomib, to see if it is safe and effective when given with a standard chemotherapy treatment for lymphoma.
Who is the study for?
This trial is for patients with certain types of B-cell lymphoma, including those with specific genetic features like MYC rearrangement. Participants must have measurable disease, adequate organ function, and an ECOG performance status of 0-3. Women must be non-pregnant, non-nursing and either postmenopausal, surgically sterile or using effective contraception; men also need to use effective contraception.Check my eligibility
What is being tested?
The study tests ixazomib citrate combined with DA-EPOCH-R chemotherapy in a phase I/II trial. Phase I seeks the highest safe dose of ixazomib without severe side effects; phase II uses this dose alongside adjusted DA-EPOCH-R based on blood cell levels between cycles. All drugs except ixazomib are FDA-approved.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion, changes in blood counts leading to increased infection risk or bleeding problems, nerve damage (neuropathy), gastrointestinal issues such as trouble swallowing or absorption problems due to GI diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of lymphoma.
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I can care for myself but may not be able to do heavy physical work.
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My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).
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I am following the required birth control or am postmenopausal.
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My cancer has a MYC gene change found by a specific test.
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I agree to use the specified methods of contraception.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II)
To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R.
Secondary outcome measures
Assess the Predictive Value of FDG-PET/CT Scans on PFS
Overall Survival (OS)
Response Rate
+1 moreOther outcome measures
Consolidation SCT (Stem Cell Transplant)
Determine the Impact of Cell of Origin (COO) Upon Response Rate, PFS, and OS
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (combination chemotherapy, rituximab, ixazomib)Experimental Treatment11 Interventions
INDUCTION:
Patients receive ixazomib citrate PO on day 1 and day 8 or 15; etoposide IV, vincristine sulfate IV, and doxorubicin hydrochloride IV continuously over 96 hours on days 1-4; prednisone PO BID on days 1-5; rituximab IV should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr on day 1; and cyclophosphamide IV over 90 minutes on day 5.
CNS PROPHYLAXIS:
Patients with a negative LP receive methotrexate IT once per course. Patients with a positive LP receive methotrexate IT or intraventricularly OR cytarabine IT or intraventricularly OR methotrexate IT or intraventricularly, cytarabine IT or intraventricularly, and therapeutic hydrocortisone IT or intraventricularly.
MAINTENANCE:
Patients not treated with consolidative SCT, receive ixazomib citrate PO BID on days 1, 8, and 15. Treatment repeats every 28 days for up to one year in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2013
Completed Phase 4
~3800
Rituximab
1999
Completed Phase 4
~1880
Cytarabine
2016
Completed Phase 3
~3310
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Cyclophosphamide
1995
Completed Phase 3
~3770
Etoposide
2010
Completed Phase 3
~2440
Prednisone
2014
Completed Phase 4
~2370
Therapeutic Hydrocortisone
2012
Completed Phase 3
~340
Ixazomib Citrate
2012
Completed Phase 2
~200
Vincristine Sulfate
2005
Completed Phase 3
~10110
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,193 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,629 Total Patients Enrolled
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,876 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received more than one cycle of chemoimmunotherapy for NHL.I have not had major surgery in the last 4 weeks.I have undergone radiotherapy within the last 14 days.I haven't taken antibiotics for an infection in the last 14 days.I have heart problems that are not well-managed or had a recent heart attack.I have an active hepatitis B or C infection.I do not have any serious illnesses that could stop me from completing treatment.I have GI issues that affect how I absorb medications.I have severe nerve damage in my hands or feet, or moderate with pain.I have been diagnosed with a specific type of lymphoma.I can care for myself but may not be able to do heavy physical work.My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).I am following the required birth control or am postmenopausal.My cancer has a MYC gene change found by a specific test.I haven't taken any specific inhibitors in the last 14 days.I am currently pregnant or nursing.I have not been diagnosed or treated for another cancer within the last 2 years.I agree to use the specified methods of contraception.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (combination chemotherapy, rituximab, ixazomib)
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.
Are people currently being recruited for this experiment?
"According to the information on clinicaltrials.gov, this particular study is not recruiting patients at this time. This trial was first posted on October 28th, 2015 and updated last on February 17th, 2022. There are 3,838 other trials currently looking for participants."
Answered by AI
What is the main goal of this research?
"The primary outcome that will be measured over a The first 21 days of treatment interval is For phase II of the study, 12-month PFS (Progression Free Survival) of ixazomib given with DA-EPOCH-R. Additionally, this study will also measure secondary outcomes including Response Rate, which is defined as Anti-tumor activity that is detected as SD (Stable Disease), Partial Response (PR), or CR (Complete Remission) by CT or PET/CT scan, and/or resolution of marrow-only involvement. CR and PR will each be assessed according to the Revised Response"
Answered by AI
Are there other documented instances of Therapeutic Hydrocortisone being used?
"Therapeutic Hydrocortisone is being trialled in 445 Phase 3 clinical studies as of now. Most of these are based in Bethesda, Maryland; however, there are 69265 locations globally where research into Therapeutic Hydrocortisone is taking place."
Answered by AI
Are there many research facilities testing this theory in Canada?
"This particular clinical trial is based out of the Medical College of Wisconsin in Milwaukee, Northwestern University in Chicago, and Tufts University near Medford. Additionally, there are 5 other sites where this study is taking place."
Answered by AI
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