Clinical Trials /

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

NCT02947347

Description:

The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma.

Related Conditions:
  • Follicular Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
  • Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)

Clinical Trial IDs

  • ORG STUDY ID: PCYC-1141-CA
  • NCT ID: NCT02947347

Conditions

  • Treatment Naive Follicular Lymphoma

Interventions

DrugSynonymsArms
ibrutinibImbruvica(Part 1 : Arm A) ibrutinib + rituximab
placebo to match ibrutinib(Part 1 : Arm B) placebo + rituximab
rituximab(Part 1 : Arm A) ibrutinib + rituximab
ibrutinibImbruvica(Part 2 : Arm A1) ibrutinib
placebo to match ibrutinib(Part 2 : Arm A2) placebo
placebo to match ibrutinib(Part 2 : Arm B) placebo

Purpose

The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma.

Trial Arms

NameTypeDescriptionInterventions
(Part 1 : Arm A) ibrutinib + rituximabExperimentalSubjects will receive 560mg of ibrutinib and rituximab 375mg/m^2 weekly x4 with maintenance. In Part 1, Arm A to Arm B ratio is 3:1
  • ibrutinib
  • rituximab
(Part 1 : Arm B) placebo + rituximabPlacebo ComparatorSubjects will receive placebo and rituximab 375mg/m^2 weekly x4 with maintenance. In Part 1, Arm A to Arm B ratio is 3:1
  • placebo to match ibrutinib
  • rituximab
(Part 2 : Arm A1) ibrutinibExperimentalSubjects will receive 560mg of ibrutinib Part 1 Arm A subjects will be re-randomized 1:1 into Part 1 Arm A1 or Arm A2
  • ibrutinib
(Part 2 : Arm A2) placeboPlacebo ComparatorSubjects will receive placebo Part 1 Arm A subjects will be re-randomized 1:1 into Part 2 Arm A1 or Arm A2
  • placebo to match ibrutinib
(Part 2 : Arm B) placeboPlacebo ComparatorSubjects will receive placebo Part 1 Arm B subjects will be re-randomized into Part 2 Arm B
  • placebo to match ibrutinib

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann
             Arbor Stage II, III or IV disease.

          -  Measurable disease

          -  Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more
             comorbidities.

          -  Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.

          -  Adequate hematologic function within protocol-defined parameters.

          -  Adequate hepatic and renal function within protocol-defined parameters.

          -  ECOG performance status score of 0-2.

        Exclusion Criteria:

          -  Transformed lymphoma

          -  Prior treatment for follicular lymphoma

          -  Central nervous system lymphoma or leptomeningeal disease

          -  Currently active, clinically significant cardiovascular disease
      
Maximum Eligible Age:N/A
Minimum Eligible Age:60 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival
Time Frame:2-5 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pharmacyclics LLC.

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