Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial involved 181 people in total. Seventy-five participants were randomly assigned to receive ibrutinib plus rituximab (two medicines given together), 75 received a placebo (a dummy pill) plus rituximab, and a further 31 took part in a separate open-label sub-study where everyone received ibrutinib. The trial was studying a blood cancer called Waldenström's macroglobulinaemia, and it was primarily measuring how long participants went without their disease getting worse — called "progression-free survival." The reported data shows that at the 54-month mark (roughly four and a half years), an estimated 68% of participants in the ibrutinib-plus-rituximab group had not experienced disease progression or death, compared with about 25% in the placebo-plus-rituximab group and about 40% in the open-label sub-study group. For secondary measures, the reported overall response rate (meaning participants whose disease showed a measurable reduction) was 76% in the ibrutinib-plus-rituximab group, 31% in the placebo-plus-rituximab group, and 77% in the open-label sub-study group. The reported data also shows that at 54 months, an estimated 87% of the ibrutinib-plus-rituximab group had not yet needed a further treatment for their cancer, compared with about 29% in the placebo-plus-rituximab group. Other secondary measures tracked included improvements in haemoglobin levels (a measure of red blood cells), fatigue scores, and overall survival at 54 months. The reported data shows that around 77% of the ibrutinib-plus-rituximab group had a sustained improvement in haemoglobin, compared with 43% in the placebo-plus-rituximab group. Estimated survival at 54 months was reported as 86% in the ibrutinib-plus-rituximab group, 84% in the placebo-plus-rituximab group, and 73% in the open-label sub-study group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40674744) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Lymphoma Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Waldenström's Macroglobulinemia (WM), either newly diagnosed or previously treated — if previously treated, your disease must have gotten worse or not responded to your most recent treatment
- Your WM diagnosis has been confirmed through a central review process
- Your disease is measurable through a specific protein (IgM) detected in your blood at a level above 0.5 g/dL
- Your WM is causing symptoms that doctors agree require treatment, based on international guidelines
- Your blood counts and organ function (such as kidneys and liver) are within the ranges required by the study
- You are 18 years of age or older
- You are well enough to carry out basic daily activities (your general health status meets the study's requirements — confirm with trial site)
Who may not be able to join:
- Your WM has spread to your brain or spinal cord
- Your disease stopped responding to a previous treatment that included a drug called rituximab, OR you relapsed within 12 months of your last rituximab dose (note: you may still be eligible for a separate part of this study — confirm with trial site)
- You received rituximab within the last 12 months before starting the study
- You have had a severe allergic reaction to rituximab or similar medicines
- You have previously taken ibrutinib or a similar type of drug (BTK inhibitor)
- You have a known bleeding disorder, such as von Willebrand's disease or hemophilia
- You have had a stroke or bleeding in the brain within the past 12 months
- You currently have an uncontrolled infection
- You have a serious illness or medical condition that the study doctor believes could put your safety at risk
- You have significant heart or cardiovascular disease that is currently active
- You are taking a certain type of medication that strongly affects how drugs are processed by your body (a "strong CYP3A inhibitor" — confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Bernhard Hauns, MD, Pharmacyclics LLC.
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.