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Enzyme Inhibitor
Ibrutinib + Ixazomib for Waldenstrom's Macroglobulinemia
Phase 2
Waitlist Available
Led By Asher A Chanan-Khan
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of measurable disease as defined by: presence of immunoglobulin M (IgM) paraprotein, measurable lymphadenopathy on imaging studies and/or physical exam, and/or bone marrow infiltration > 10%
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial looks at the side effects of two drugs, ibrutinib and ixazomib, when given together to treat Waldenstrom macroglobulinemia. Enzyme inhibitors, such as ibrutinib and ixazomib, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
This trial is for adults with Waldenstrom macroglobulinemia, whether newly diagnosed, relapsed or treatment-resistant. Participants must be able to give consent, provide blood and bone marrow samples, have certain minimum blood counts and organ function levels, not be pregnant or breastfeeding, use effective contraception if of childbearing potential, and have no major surgery planned.Check my eligibility
What is being tested?
The study tests the effectiveness and side effects of combining two enzyme inhibitors: Ibrutinib citrate and Ixazomib citrate in treating Waldenstrom macroglobulinemia. It includes laboratory biomarker analysis along with pharmacodynamic and pharmacokinetic studies to understand how these drugs work together against cancer cells.See study design
What are the potential side effects?
Potential side effects may include digestive issues due to interference with oral absorption; heart problems like uncontrolled hypertension or arrhythmias; liver dysfunction; nerve pain or neuropathy; increased risk of infection; allergic reactions to medication components; fatigue from anemia or low platelet count.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have signs of disease like specific proteins in my blood, swollen lymph nodes, or more than 10% of my bone marrow is affected.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My platelet count is at least 75,000 and was tested within the last 14 days without transfusions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate (CR)
Secondary outcome measures
Incidence of adverse effects (AE) graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0
Overall response rate
Overall survival
+1 moreOther outcome measures
BTK signaling proteins (western blot and densitometric quantification) and gene expression (quantitative real-time polymerase chain reaction [PCR]) examined in CD19/CD138+ Waldenstrom macroglobulinemia (WM) cells
Biologic effects of ibrutinib and ixazomib citrate on microenvironment in WM
Side effects data
From 2023 Phase 2 trial • 2 Patients • NCT03477396100%
Alanine aminotransferase increased
100%
Cough
100%
Neutrophil count decreased
100%
Fatigue
100%
Alkaline phosphatase increased
100%
Aspartate aminotransferase increased
100%
White blood cell decreased
100%
Hyponatremia
100%
Nausea
50%
Anxiety
50%
Alopecia
50%
Vomiting
50%
Gastroesophageal reflux disease
50%
Creatinine increased
50%
Cholesterol high
50%
Dry skin
50%
Dyspnea
50%
Lymphocyte count decreased
50%
Sore throat
50%
Hot flashes
50%
Epistaxis
50%
Rash acneiform
50%
left upper eyelid droop
50%
Anorexia
50%
Constipation
50%
Dyspepsia
50%
Chills
50%
Pain
50%
Edema limbs
50%
blood in stool
50%
Upper respiratory infection
50%
Platelet count decreased
50%
Hyperglycemia
50%
Hyperkalemia
50%
Hypertriglyceridemia
50%
Hypoalbuminemia
50%
Hypoglycemia
50%
Arthralgia
50%
Osteoporosis
50%
Headache
50%
Memory impairment
50%
Depression
50%
Anemia
50%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Ribociclib, Aromatase Inhibitor)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ixazomib citrate, ibrutinib)Experimental Treatment5 Interventions
Patients receive ixazomib citrate PO on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Ibrutinib
FDA approved
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,761 Total Patients Enrolled
11 Trials studying Waldenstrom Macroglobulinemia
493 Patients Enrolled for Waldenstrom Macroglobulinemia
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,130 Total Patients Enrolled
137 Trials studying Waldenstrom Macroglobulinemia
8,737 Patients Enrolled for Waldenstrom Macroglobulinemia
Asher A Chanan-KhanPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled heart or blood pressure problems.My condition is confirmed Waldenstrom macroglobulinemia, whether new, relapsed, or refractory.I have signs of disease like specific proteins in my blood, swollen lymph nodes, or more than 10% of my bone marrow is affected.I can take care of myself but might not be able to do heavy physical work.I have moderate to severe nerve damage in my hands or feet, or mild nerve damage with pain.I have an active hepatitis B or C infection, or I am HIV positive.I am currently being treated with ibrutinib and strong CYP3A inhibitors.Your hemoglobin level needs to be 9.0 grams per deciliter or higher in a blood test taken within 14 days before enrolling in the study.I haven't had major surgery or a biopsy in the last 14 days and don't expect to need one soon.I had radiotherapy less than 2 weeks ago, or less than a week ago for a small area.I haven't taken any strong medication or St. John's wort in the last 14 days.I haven't had any cancer treatment or joined other clinical trials in the last 28 days.I am currently breastfeeding.I don't have GI issues that affect medicine absorption.Your absolute neutrophil count is at least 1000 per cubic millimeter of blood.I have not been treated with ixazomib but may have had bortezomib if my disease did not resist it.My condition involves the central nervous system.I haven't needed antibiotics for a serious infection in the last week.I have had cancer before, but it was either early stage, treated non-melanoma skin cancer, in situ cancer, or I've been cancer-free for 2 years.I am willing to use effective birth control or practice true abstinence.My kidney function, measured by creatinine clearance, is adequate.My platelet count is at least 75,000 and was tested within the last 14 days without transfusions.I still have mild side effects from my previous WM treatment.Your bilirubin level must be within a certain range, unless you have Gilbert's syndrome, in which case a different bilirubin level is allowed.Women who can have children must have a recent negative pregnancy test before joining the study.My liver is not working well (Child-Pugh B or C).My liver function tests are within normal limits.I am willing to go back to the hospital where I enrolled for my check-ups.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ixazomib citrate, ibrutinib)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Is enrollment for this experiment currently open to volunteers?
"As elucidated on clinicaltrials.gov, this research is not currently enrolling candidates. The investigation began recruitment on July 5th 2018 and was most recently amended October 7th 2022. Despite the fact that it's no longer seeking participants, there are 305 other trials which presently require volunteers."
Answered by AI
How extensive is the scope of this experiment in terms of participant numbers?
"This clinical trial has concluded its recruitment period; the first posting was on July 5th 2018 and there have been no updates since October 7th 2022. There are currently 83 trials looking for participants with Waldenstrom Macroglobulinemia and 222 studies searching for candidates to partake in a Pharmacokinetic Study."
Answered by AI
What health conditions are most frequently addressed through pharmacokinetic study?
"Pharmacokinetic Study can be employed to treat patients with mantle cell lymphoma (MCL), Waldenstrom Macroglobulinemia, and Chronic lymphocytic leukemia (CLL)."
Answered by AI
What risks might be associated with a Pharmacokinetic Study?
"Data suggests that the pharmacokinetic study is relatively safe, scoring a 2 on our scale. This rating reflects the fact that there have been some studies testing safety but none assessing efficacy yet."
Answered by AI
Have any other studies explored the Pharmacokinetic Study?
"The Pharmacokinetic Study was first conducted at the National Institutes of Health Clinical Center in Rockville, Maryland back in 2011. Subsequently, there have been 711 completed studies and 222 active clinical trials occurring around Jacksonville, Florida."
Answered by AI
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