Clinical Trial: Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Investigator Sponsored Multi-Centre Trial of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma

Brief Summary: The purpose of this study is to assess the efficacy and safety of Ibrutinib in predominantly Asian patients with relapsed or refractory marginal zone lymphoma.

Detailed Summary:

Patient sample:

Patients with histologically proven marginal zone lymphoma (splenic, nodal and extra-nodal subtypes included).

Other important requirements for recruitment into the study:

  • Prior treatment with one or more lines rituximab or rituximab-based chemoimmunotherapy with failure to achieve at least a partial response (PR) or documented disease progression
  • Age ≥ 21 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • At least 1 measurable disease site on computed tomography (CT) scan that is at least 1.5cm in the longest dimension.
  • Patient must have an indication for treatment e.g., symptoms from disease, bulky disease (>5cm), threatened end-organ function, or cytopenias requiring transfusion or growth factor support

Dosage and Dose Regimen:

560mg of Ibrutinib is administered orally once daily. Patients with mild liver impairment (Child's-Pugh A), ibrutinib 140mg (1 x 140mg capsule) will be administered instead. The patient will continue on treatment until one of the following occurs:

  • Patient has disease progression (as assessed by the investigator).
  • Patient has an intercurrent illness or adverse events that prevents further ibrutinib administration.
  • Patient decides to withdraw from the study.
  • Investigator considers withdrawal to be in the best interest of the patient.
    • Sponsor: National Cancer Centre, Singapore

    Current Primary Outcome: Overall Response Rates [ Time Frame: From time of first study drug administration until best overall response of CR or PR is achieved, up to 3 years ]

    Proportion of patients who achieve either a Complete Response (CR) or Partial Response (PR) as best response


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Progression-Free Survival [ Time Frame: From time of first study drug administration until first occurence of disease progression or death from any cause, up to 3 years ]
    • Overall Survival [ Time Frame: From time of first study drug administration until death from any cause, up to 3 years ]
    • Frequency and severity of adverse events [ Time Frame: From the time the ICF is signed until 30 days after the last dose of the study drug ]
    • Frequency of adverse events requiring discontinuation of study drug or dose reductions [ Time Frame: From the time the ICF is signed until 30 days after the last dose of the study drug ]


    Original Secondary Outcome: Same as current

    Information By: National Cancer Centre, Singapore

    Dates:
    Date Received: March 23, 2017
    Date Started: July 8, 2016
    Date Completion: January 2021
    Last Updated: March 23, 2017
    Last Verified: March 2017