Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

Completed · Phase 3 · Has a placebo group

Conditions studied: Waldenström's Macroglobulinemia

In brief

The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).

Key facts

Study ID

NCT02165397

Run by

Pharmacyclics LLC.

People needed

181

Starts

2014-07-07

Expected to finish

2019-11-07

Last updated by the study team

2021-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Untreated or previously treated for WM. Previously treated subjects must have either documented disease progression or had no response (stable disease) to the most recent treatment regimen
• Centrally confirmed clinicopathological diagnosis of WM
• Measurable disease defined as serum monoclonal immunoglobulin M (IgM) >0.5 g/dL
• Symptomatic disease meeting at least 1 of the recommendations from the Second International Workshop on Waldenström Macroglobulinemia for requiring treatment
• Hematology and biochemical values within protocol-defined limits
• Men and women ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

You may not qualify if…

• Known involvement of the central nervous system by WM
• Disease that is refractory to the last prior rituximab-containing therapy defined as either
• Relapse after the last rituximab-containing therapy < 12 months since last dose of rituximab, OR
• Failure to achieve at least a minor response (MR) after the last rituximab-containing therapy If the subject meets this exclusion criterion and therefore is excluded from the main randomized study, participation in the non randomized substudy (Arm C) may be considered
• Rituximab treatment within the last 12 months before the first dose of study drug
• Known anaphylaxis or (immunoglobulin E) IgE-mediated hypersensitivity to murine proteins or to any component of rituximab
• Prior exposure to ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitors
• Known bleeding disorders (eg, von Willebrand's disease) or hemophilia
• History of stroke or intracranial hemorrhage within 12 months prior to enrollment.
• Any uncontrolled active systemic infection.
• Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
• Currently active, clinically significant cardiovascular disease
• Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
• Eligibility Criteria for Open-label Substudy Treatment Arm C
• The inclusion/exclusion criteria for the substudy (Arm C) are identical to those described above for the randomized study but, to be eligible, subjects need to be considered refractory to the last prior rituximab-containing therapy defined as either
• Relapse after the last rituximab-containing therapy <12 months since last dose of rituximab, OR
• Failure to achieve at least a MR after the last rituximab-containing therapy.

Where it is running

• University of California Los Angeles — Los Angeles, California, United States
• Stanford Cancer Center — Palo Alto, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical Center — New York, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The Canberra Hospital — Garran, Australian Capital Territory, Australia
• Concord Repartriation General Hospital — Concord, New South Wales, Australia
• Flinders Medical Center — Bedford Park, South Australia, Australia
• Peter MacCallum Cancer Center — Melbourne, Victoria, Australia
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Queen Elizabeth II Health Sciences Center — Halifax, Nova Scotia, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada
• McGill University Health Center — Montreal, Quebec, Canada
• Institut Paoli-Calmettes — Marseille, Bouches-du-Rhône, France
• Centre Hospitalier de Saint Brieuc Hopital Yves le Foll — Saint-Brieuc, Finistère, France
• Hôtel Dieu — Nantes, Loire-Atlantique, France
• CHU de Nancy-Hopital Brabois Adulte — Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
• Hôpital Claude Huriez — Lille, Nord, France
• CHU Estaing — Clermont-Ferrand, Puy-de-Dôme, France
• Centre Hospitalier Lyon Sud — Pierre-Bénite, Rhône, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.