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Phase 2 N=16 Treatment

A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM)

Waldenstrom Macroglobulinemia

Enrolled (actual)
16
Serious AEs
25.0%
Results posted
Dec 2022
Primary outcome: Primary: Overall Response Rate (ORR) According to the Modified Sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) Criteria — 87.5 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Ibrutinib (Drug); Rituximab (Drug)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
Janssen Pharmaceutical K.K.
Primary completion
Aug 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Response Rate (ORR) According to the Modified Sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) Criteria
87.5
SECONDARY
Progression Free Survival (PFS) Assessed by Independent Review Committee
NA
SECONDARY
Plasma Concentrations of Ibrutinib
4.10; 55.6; 94.9; 89.9; 50.5
SECONDARY
Plasma Concentrations of Metabolite PCI-45227
13.7; 39.9; 63.9; 79.6; 65.6
SECONDARY
Number of Participants With Myeloid Differentiation Primary Response Gene 88 (MYD88) Biomarker Mutation
6
SECONDARY
Number of Participants With C-X-C Chemokine Receptor Type 4 (CXCR-4) Biomarker Mutations
2
SECONDARY
Number of Participants With Treatment- Emergent Adverse Events (TEAEs)
16

Summary

The purpose of this study is to evaluate overall response rate (ORR) by Independent Review Committee (IRC) assessment, when combined with rituximab in Japanese participants with treatment naïve or relapsed/refractory Waldenstrom's Macroglobulinemia (WM).

Eligibility Criteria

Inclusion Criteria

  • Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia (WM) in accordance with the consensus panel of the second International Workshop on Waldenstrom's Macroglobulinemia (IWWM)
  • Japanese participants with treatment naïve or relapsed/refractory WM
  • Measurable disease defined as serum monoclonal immunoglobulin M (IgM) greater than (>) 0.5 gram per deciliter (g/dL)
  • Symptomatic disease, requiring treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to ( 35 days from the most recent plasmapheresis procedure
  • History of other malignancies
  • Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
  • Infection requiring systemic treatment that was completed <=14 days before the first dose of study drug
  • Currently active, clinically significant Child-Pugh Class B or C hepatic impairment
  • Inability or difficulty swallowing capsules, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
  • Stroke or intracranial hemorrhage within 12 months prior to enrollment
  • Currently active, clinically significant cardiovascular disease
  • Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
  • Infection with human immunodeficiency virus (HIV) or active infection with hepatitis B or hepatitis C virus
  • Major surgery within 4 weeks of first dose of study drug
  • Lactating or pregnant
  • Male participants who plan to father a child while enrolled in this study or within 3 months after the last dose of ibrutinib, and within 12 months after last dose of rituximab
  • Any contraindication to ibrutinib or rituximab including hypersensitivity to the active substance or to any of the excipients of ibrutinib or rituximab per local prescribing information
  • Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the planned first dose of study intervention or is currently enrolled in an investigational study
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg [for example], compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments
  • Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04062448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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