Recurrent Waldenstrom MacroglobulinemiaPhase 2NCT03506373
Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia
A Phase 2 study testing Ibrutinib, Ixazomib Citrate and Laboratory Biomarker Analysis in people with Recurrent Waldenstrom Macroglobulinemia and Refractory Waldenstrom Macroglobulinemia, run by Mayo Clinic at 2 sites in United States.
Trial summary
This phase II trial studies the side effects of ibrutinib citrate when given with ixazomib, and determines how well they work in treating patients with Waldenstrom macroglobulinemia that is newly diagnosed, has come back (recurrent) or does not respond to treatment (refractory). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Waldenstrom Macroglobulinemia, Refractory Waldenstrom Macroglobulinemia, Waldenstrom Macroglobulinemia
- What is being tested?
- Ibrutinib, Ixazomib Citrate and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Aug 2018to 3 Feb 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of WM; patients may have newly diagnosed, relapsed, or refractory disease; (definition: newly diagnosed; patients previously untreated for WM, relapse; patients who have received prior treatment for WM and now have disease recurrence; refractory; patients who have received anti-WM therapy and are noted to have progressive disease while on therapy, or those patients who demonstrated disease progression within 6 months of the last anti-WM treatment); NOTE: Ibrutinib naïve patients are allowed; if previously treated with ibrutinib, subject must have reached a response of at least stable disease (SD) and cannot have progressed while on ibrutinib; if subject stopped taking ibrutinib for reasons other than progression, they cannot have progressed for at least 6 months post last dose of ibrutinib
- 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
- Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 14 days prior to registration)
- Platelet count >= 75,000/mm^3 (obtained =< 14 days prior to registration) (NOTE: platelet transfusions in order to help patients meet eligibility criteria are not allowed)
- Hemoglobin >= 9.0 g/dL (obtained =< 14 days prior to registration)
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- Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome, in which case the direct bilirubin must be =< 1.5 x ULN (obtained =< 14 days prior to registration)
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (obtained =< 14 days prior to registration)
- Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft Gault formula (obtained =< 14 days prior to registration)
- Negative pregnancy test done at screening and =< 3 days (72 hours) prior to registration, for women of childbearing potential
- Provide written informed consent
- Willingness to provide mandatory blood specimens and bone marrow specimens for correlative research
- Willingness to return to enrolling institution for follow-up
Who cannot join
- Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior treatment for WM
- Major surgical procedure (including open biopsy, excluding central line intravenous (IV) and port-a-cath placement) within =< 14 days prior to initiating study treatment, or anticipation of the need for major surgery during the course of the study treatment
- Radiotherapy =< 14 days prior to registration; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
- Systemic treatment, =< 14 days before registration, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or St. John's wort
- Systemic anti-cancer therapy or participation in other clinical trials, including those with other investigational agents not included in this trial, =< 28 days of registration and throughout the duration of active treatment in this trial
- Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not; prior bortezomib treatment is allowed as per: patients with prior exposure to bortezomib will be allowed if they do not have disease refractory to bortezomib)
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- Central nervous system involvement (Bing-Neel syndrome)
- Infection requiring systemic antibiotic therapy or other serious infection =< 7 days prior to registration
- 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
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib or ibrutinib, including difficulty swallowing
- History of any other prior malignancy; (NOTE: Exception to this are adequately treated non-melanoma skin cancers, any in situ cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least two years prior to study enrollment)
- Patient has >= grade 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination during the screening period
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
- Pregnant women
- Nursing women
- Men or women of child bearing potential (WCBP) who are unwilling to employ effective contraception; effective contraception would be defined as utilizing 2 simultaneous methods of contraception from the time of signing consent through 90 days after the last dose of the study drugs unless they agree to participate in true abstinence when this is in line with the preferred and usual lifestyle of the subject; (WCBP: A female who is sexually mature and who: [1] has not undergone a hysterectomy or bilateral oophorectomy; or [2] has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time in the preceding 24 consecutive months])
- Evidence of any other serious medical condition (such as psychiatric illness, infectious diseases, physical or laboratory findings) that may interfere with the planned treatment, affect compliance or place the patient at high risk from treatment-related complications or potentially interfere with the completion of the treatment as per the protocol
- Ongoing, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive
- Liver disease with Child-Pugh class B or C liver dysfunction
- Current treatment with a combination of ibrutinib and strong CYP3A inhibitors
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Phase II Study of Ibrutinib in Combination With Ixazomib in Patients With Waldenström Macroglobulinemia
This phase II trial studies the side effects of ibrutinib citrate when given with ixazomib, and determines how well they work in treating patients with Waldenstrom macroglobulinemia that is newly diagnosed, has come back (recurrent) or does not respond to treatment (refractory). Enzyme inhibitors, such as ibrutinib and ixazomib citrate, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy (as assessed by complete response [CR] rate) of the combination of ixazomib citrate (ixazomib) and ibrutinib in Waldenstrom macroglobulinemia (WM) patients.
SECONDARY OBJECTIVES:
- To assess the overall response rate (ORR=partial response [PR] or better) in WM patients treated with ixazomib and ibrutinib.
II. To assess the time to progression (TTP) in WM patients treated with ixazomib and ibrutinib.
III. To further characterize the safety and toxicity of the combination of ibrutinib and ixazomib.
IV. To assess the overall survival (OS) in WM patients treated with ixazomib and ibrutinib.
CORRELATIVE RESEARCH OBJECTIVES:
- To determine the role of members of the BTK signalosome in achievement or lack thereof of response to ibrutinib and ixazomib.
II. To explore biologic effects of ibrutinib and ixazomib on microenvironment in WM and correlate with response to treatment.
OUTLINE:
Patients receive ixazomib citrate orally (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.
After completion of study treatment, patients are followed up every 3 months for up to 2 years.
- Conditions
- Recurrent Waldenstrom Macroglobulinemia, Refractory Waldenstrom Macroglobulinemia, Waldenstrom Macroglobulinemia
- Being tested
- Ibrutinib, Ixazomib Citrate, Laboratory Biomarker Analysis, Pharmacodynamic Study, Pharmacokinetic Study
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765
Given PO
Ixazomib CitrateDrug
Also called MLN-9708, MLN9708, Ninlaro
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Pharmacodynamic StudyOther
Also called PHARMACODYNAMIC
Correlative studies
Pharmacokinetic StudyOther
Also called PHARMACOKINETIC, PK Study
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ixazomib citrate, ibrutinib) | Experimental | 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. Receives: Drug: Ibrutinib; Drug: Ixazomib Citrate; Other: Laboratory Biomarker Analysis; Other: Pharmacodynamic Study; Other: Pharmacokinetic Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CR)
Complete response rate to be defined as an objective status of CR at any time, where confirmation of the complete response status is required on two consecutive evaluations with a second immunofixation before calling the patient a CR. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Categorized by Response Assessment Criteria as specified in Appendix III of the protocol.
Measured: 4 years
Secondary outcomes (4)
Overall Response Rate
Overall response rate will be estimated by the total number of patients who achieve a CR, very good partial response (VGPR), or partial response (PR) divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. Response is categorized by Response Assessment Criteria as specified in Appendix III of the protocol.
Measured: Up to 5 years
Progression-free Survival
The median time to progression will be estimated using the method of Kaplan-Meier. Categorized by Response Assessment Criteria as specified in Appendix III of the protocol.
Measured: From study registration to the earliest date of documentation of disease progression, assessed up to 5 years
Overall Survival
Defined as the time from study enrollment until death due to any cause. The median overall survival will be estimated using the method of Kaplan-Meier.
Measured: Up to 5 years
Number of Patients Experiencing Grade 3+ Adverse Effects (AE) Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version (v.) 4.0
The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the AE(s) to the study treatment will be taken into consideration.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start14 Aug 2018
- Primary completion6 Feb 2023
- Study completion3 Feb 2026
Why it stopped: Discontinued after interim analysis for futility; no treatment successes observed in the first 12 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Waldenstrom MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asher A. Chanan-Khan, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506373
- Sponsor's protocol ID
- MC178B
- Other IDs
- 18-000580
- Status last verified
- Feb 2026
- First submitted
- 11 Apr 2018
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Ibrutinib in Combination With Ixazomib in Patients With Waldenström Macroglobulinemia
- ClinicalTrials.gov ID
- NCT03506373
- Acronym / sponsor ID
- MC178B
- Conditions
- Recurrent Waldenstrom Macroglobulinemia, Refractory Waldenstrom Macroglobulinemia, Waldenstrom Macroglobulinemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued after interim analysis for futility; no treatment successes observed in the first 12 patients
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Posted 18 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the side effects of ibrutinib citrate when given with ixazomib, and determines how well they work in treating patients with Waldenstrom macroglobulinemia that is newly diagnosed, has come back (recurrent) or does not respond to treatment (refractory). Enzyme inhibitors, such as ibrutinib and ixazomib citrate, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy (as assessed by complete response [CR] rate) of the combination of ixazomib citrate (ixazomib) and ibrutinib in Waldenstrom macroglobulinemia (WM) patients.
SECONDARY OBJECTIVES:
- To assess the overall response rate (ORR=partial response [PR] or better) in WM patients treated with ixazomib and ibrutinib.
II. To assess the time to progression (TTP) in WM patients treated with ixazomib and ibrutinib.
III. To further characterize the safety and toxicity of the combination of ibrutinib and ixazomib.
IV. To assess the overall survival (OS) in WM patients treated with ixazomib and ibrutinib.
CORRELATIVE RESEARCH OBJECTIVES:
- To determine the role of members of the BTK signalosome in achievement or lack thereof of response to ibrutinib and ixazomib.
II. To explore biologic effects of ibrutinib and ixazomib on microenvironment in WM and correlate with response to treatment.
OUTLINE:
Patients receive ixazomib citrate orally (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.
After completion of study treatment, patients are followed up every 3 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ixazomib citrate, ibrutinib) | Experimental | Drug: Ibrutinib, Drug: Ixazomib Citrate, Other: Laboratory Biomarker Analysis, Other: Pharmacodynamic Study, Other: Pharmacokinetic StudyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histological confirmation of WM; patients may have newly diagnosed, relapsed, or refractory disease; (definition: newly diagnosed; patients previously untreated for WM, relapse; patients who have received prior treatment for WM and now have disease recurrence; refractory; patients who have received anti-WM therapy and are noted to have progressive disease while on therapy, or those patients who demonstrated disease progression within 6 months of the last anti-WM treatment); NOTE: Ibrutinib naïve patients are allowed; if previously treated with ibrutinib, subject must have reached a response of at least stable disease (SD) and cannot have progressed while on ibrutinib; if subject stopped taking ibrutinib for reasons other than progression, they cannot have progressed for at least 6 months post last dose of ibrutinib
- 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
- Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 14 days prior to registration)
- Platelet count >= 75,000/mm^3 (obtained =< 14 days prior to registration) (NOTE: platelet transfusions in order to help patients meet eligibility criteria are not allowed)
Key exclusion criteria (21 listed)
- Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior treatment for WM
- Major surgical procedure (including open biopsy, excluding central line intravenous (IV) and port-a-cath placement) within =< 14 days prior to initiating study treatment, or anticipation of the need for major surgery during the course of the study treatment
- Radiotherapy =< 14 days prior to registration; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
- Systemic treatment, =< 14 days before registration, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or St. John's wort
- Systemic anti-cancer therapy or participation in other clinical trials, including those with other investigational agents not included in this trial, =< 28 days of registration and throughout the duration of active treatment in this trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbrutinibAlso: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765Given PO | Drug | Treatment (ixazomib citrate, ibrutinib) |
| Ixazomib CitrateAlso: MLN-9708, MLN9708, NinlaroGiven PO | Drug | Treatment (ixazomib citrate, ibrutinib) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (ixazomib citrate, ibrutinib) |
| Pharmacodynamic StudyAlso: PHARMACODYNAMICCorrelative studies | Other | Treatment (ixazomib citrate, ibrutinib) |
| Pharmacokinetic StudyAlso: PHARMACOKINETIC, PK StudyCorrelative studies | Other | Treatment (ixazomib citrate, ibrutinib) |
Primary outcome
Complete Response Rate (CR)
Time frame: 4 years
Complete response rate to be defined as an objective status of CR at any time, where confirmation of the complete response status is required on two consecutive evaluations with a second immunofixation before calling the patient a CR. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Categorized by Response Assessment Criteria as specified in Appendix III of the protocol.
4 secondary outcomes
Overall Response Rate
Time frame: Up to 5 years
Progression-free Survival
Time frame: From study registration to the earliest date of documentation of disease progression, assessed up to 5 years
Overall Survival
Time frame: Up to 5 years
Number of Patients Experiencing Grade 3+ Adverse Effects (AE) Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version (v.) 4.0
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asher A. Chanan-Khan, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibrutinib, Ixazomib Citrate and Laboratory Biomarker Analysis in people with Recurrent Waldenstrom Macroglobulinemia and Refractory Waldenstrom Macroglobulinemia, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (CR) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.