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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more

Other 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 2023 Phase 2 trial • 2 Patients • NCT03477396

100%

White blood cell decreased

100%

Nausea

100%

Fatigue

100%

Alanine aminotransferase increased

100%

Neutrophil count decreased

100%

Cough

100%

Hyponatremia

100%

Alkaline phosphatase increased

100%

Aspartate aminotransferase increased

50%

Chills

50%

Lymphocyte count decreased

50%

Platelet count decreased

50%

Vomiting

50%

Pain

50%

Hyperkalemia

50%

Hypoglycemia

50%

Arthralgia

50%

Dyspnea

50%

Epistaxis

50%

Sore throat

50%

Rash acneiform

50%

Hot flashes

50%

Edema limbs

50%

Upper respiratory infection

50%

Anorexia

50%

Hyperglycemia

50%

Memory impairment

50%

Anxiety

50%

left upper eyelid droop

50%

Dyspepsia

50%

blood in stool

50%

Hypoalbuminemia

50%

Alopecia

50%

Gastroesophageal reflux disease

50%

Depression

50%

Constipation

50%

Cholesterol high

50%

Hypertriglyceridemia

50%

Osteoporosis

50%

Headache

50%

Creatinine increased

50%

Dry skin

50%

Anemia

50%

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Ribociclib, Aromatase Inhibitor)

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

0 / 13Eligibility criteria met