Trial Search Results

Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

The purpose of this study is to evaluate the safety and efficacy of Ibrutinib in combination with Rituximab in subjects with Waldenström's Macroglobulinemia.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Pharmacyclics LLC.

Collaborator: Janssen Research & Development, LLC

Stanford Investigator(s):

Intervention(s):

  • Drug: Ibrutinib
  • Drug: Placebo
  • Drug: Rituximab

Phase:

Phase 3

Eligibility


Eligibility Criteria for the Randomized Study (Arm A and Arm B)

Inclusion Criteria:

   - Untreated or previously treated for Waldenström's macroglobulinemia. 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 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.

Exclusion Criteria:

   - 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 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 IgE-mediated hypersensitivity to murine proteins or to any
   component of rituximab.

   - Prior exposure to ibrutinib or other 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting