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Enzyme Inhibitor
Ibrutinib + Ixazomib for Waldenstrom's Macroglobulinemia
Phase 2
Waitlist Available
Led By Asher A. Chanan-Khan, M.D.
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
Must not have
Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, serious cardiac arrhythmia requiring medication (other than adequately rate-controlled atrial fibrillation), symptomatic congestive heart failure, unstable angina, stroke/transient ischemic attack (TIA) within the past 6 months or myocardial infarction within the past 6 months
Patient has >= grade 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination during the screening period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
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.
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.
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.
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I can take care of myself but might not be able to do heavy physical work.
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My platelet count is at least 75,000 and was tested within the last 14 days without transfusions.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any uncontrolled heart or blood pressure problems.
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I have moderate to severe nerve damage in my hands or feet, or mild nerve damage with pain.
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I have an active hepatitis B or C infection, or I am HIV positive.
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I am currently being treated with ibrutinib and strong CYP3A inhibitors.
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I haven't had major surgery or a biopsy in the last 14 days and don't expect to need one soon.
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I haven't had any cancer treatment or joined other clinical trials in the last 28 days.
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I am currently breastfeeding.
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I don't have GI issues that affect medicine absorption.
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My condition involves the central nervous system.
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My liver is not working well (Child-Pugh B or C).
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete response rate (CR)
Secondary study objectives
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 study objectives
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 2024 Phase 2 trial • 18 Patients • NCT0337071878%
Alanine aminotransferase increased
78%
Diarrhea
72%
Aspartate aminotransferase increased
72%
White blood cell decreased
67%
Weight loss
67%
Hypertension
61%
Alkaline phosphatase increased
56%
Fatigue
50%
Hypophosphatemia
50%
Nausea
50%
Proteinuria
44%
Increased TSH
44%
Lipase increased
44%
Palmar-plantar erythrodysesthesia syndrome
44%
Dysgeusia
39%
Platelet count decreased
39%
Creatinine increased
39%
Increased amylase
39%
Increased GGT
39%
Abdominal pain
39%
Anemia
39%
Increased LDH
33%
Blood bilirubin increased
33%
Mucositis oral
33%
Anorexia
33%
Dry skin
33%
Hyperglycemia
33%
Vomiting
33%
Hypoalbuminemia
28%
Erythema/Rash
28%
Hypokalemia
28%
Hypomagnesemia
28%
Headache
28%
Skin hypopigmentation
22%
Insomnia
22%
Constipation
22%
Muscle cramps
22%
Hair color changing
17%
Dyspnea
17%
Muscle weakness
17%
Back pain
17%
Hypercalcemia
17%
Hoarseness
17%
Paresthesia
17%
Hypothyroidism
17%
Thromboembolic event
11%
Dyspepsia
11%
Dizziness
11%
Dry mouth
11%
Heat intolerance
11%
Increased calluses on feet
11%
Lightheadedness
11%
Sinus tachycardia
11%
Sore throat
11%
Voice change
11%
GGT increased
11%
Increased PTT
11%
Bruising
11%
Extremity pain
11%
Flank pain
11%
Hyponatremia
11%
Myalgia
11%
Oral hemorrhage
11%
Pleural effusion
11%
Free T4 alteration
11%
Stomatitis
6%
Renal Insufficiency
6%
Skin infection
6%
Syncope
6%
Tremor
6%
Weight gain
6%
Cough
6%
Dysphagia
6%
Decreased Chloride
6%
Hand pain/ joint stiffness
6%
Hematemesis
6%
Hyperkalemia
6%
Increased BUN
6%
INR increased
6%
Intracranial hemorrhage
6%
Itching
6%
Melanoma In Situ
6%
Nasal discharge
6%
Oral pain
6%
Pneumothorax
6%
Sinus bradycardia
6%
Slow growth of hair
6%
Total Protein decreased
6%
Tumor pain
6%
Urinary tract pain
6%
Nasal congestion
6%
Skin hyperpigmentation
6%
Gait disturbance
6%
Increased Total Protein
6%
Ureteral obstruction
6%
Increased PT
6%
Acne
6%
Belching
6%
Cholecystitis
6%
Acute respiratory failure
6%
Arthralgia
6%
Chronic kidney disease
6%
Cortisol increase
6%
Edema
6%
Epistaxis
6%
Facial pain
6%
Gingival pain
6%
Hair loss
6%
Hemorrhoidal hemorrhage
6%
Hydronephrosis
6%
Hypocalcemia
6%
Increased Globulin
6%
Increased skin sensitivity
6%
Increased T4
6%
Irregular menstruation
6%
Loss of Peripheral vision
6%
Odynophagia
6%
Osteonecrosis of jaw
6%
Pallor
6%
Pancreatitis
6%
Peeling and Dry blistering
6%
Pneumonia bibasilar
6%
Sinus disorder
6%
Soreness on sole of feet
6%
Urinary hesitancy
6%
Thyrotoxicosis
6%
Radiculitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabozantinib
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
3,362 Previous Clinical Trials
3,065,937 Total Patients Enrolled
12 Trials studying Waldenstrom Macroglobulinemia
539 Patients Enrolled for Waldenstrom Macroglobulinemia
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,063 Total Patients Enrolled
137 Trials studying Waldenstrom Macroglobulinemia
8,459 Patients Enrolled for Waldenstrom Macroglobulinemia
Asher A. Chanan-Khan, M.D.Principal InvestigatorMayo Clinic
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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.