Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

• ClinicalTrials.gov Identifier: NCT02947347
• Recruitment Status: Active, not recruiting
• First Posted: October 27, 2016
• Last Update Posted: September 9, 2022
• Sponsor: Pharmacyclics LLC.
• Information provided by (Responsible Party): Pharmacyclics LLC.

Tracking Information

• First Submitted Date: October 26, 2016
• First Posted Date: October 27, 2016
• Last Update Posted Date: September 9, 2022
• Actual Study Start Date: January 2017
• Estimated Primary Completion Date: June 2026 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 26, 2016): Progression-free survival [ Time Frame: 2-5 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 23, 2021)

• Overall Response Rate (ORR) [ Time Frame: 2-5 years ]
  Part 1
• Overall Survival [ Time Frame: 2-5 years ]
  Part 1
• Infusion-Related Reaction Rate [ Time Frame: 2-5 years ]
  Arm A vs. Arm B (Part 1)
• Adverse Events [ Time Frame: 2-5 years ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Follicular Lymphoma

Intervention

• Drug: ibrutinib
  ibrutinib 560mg administered orally
  Other Name: Imbruvica
• Drug: placebo to match ibrutinib
  placebo capsules to match ibrutinib administered orally
• Drug: rituximab
  rituximab 375mg/m^2 IV

Study Arms

• Experimental: (Part 1 : Arm A) ibrutinib + rituximab

  Subjects 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

  Interventions:

  • Drug: ibrutinib
  • Drug: rituximab
• Placebo Comparator: (Part 1 : Arm B) placebo + rituximab

  Subjects will receive placebo and rituximab 375mg/m^2 weekly x4 with maintenance.

  In Part 1, Arm A to Arm B ratio is 3:1

  Interventions:

  • Drug: placebo to match ibrutinib
  • Drug: rituximab
• Experimental: (Part 2 : Arm A1) ibrutinib

  Subjects will receive 560mg of ibrutinib

  Part 1 Arm A subjects will be re-randomized 1:1 into Part 1 Arm A1 or Arm A2

  Intervention: Drug: ibrutinib
• Placebo Comparator: (Part 2 : Arm A2) placebo

  Subjects will receive placebo

  Part 1 Arm A subjects will be re-randomized 1:1 into Part 2 Arm A1 or Arm A2

  Intervention: Drug: placebo to match ibrutinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 20, 2021): 431
• Original Estimated Enrollment (submitted: October 26, 2016): 440
• Estimated Study Completion Date: June 2026
• Estimated Primary Completion Date: June 2026 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, Canada, Czechia, France, Greece, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States

Administrative Information

• NCT Number: NCT02947347
• Other Study ID Numbers: PCYC-1141-CA; 2016-003202-14 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pharmacyclics LLC.
• Original Responsible Party: Same as current
• Current Study Sponsor: Pharmacyclics LLC.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Pharmacyclics LLC.
• Verification Date: September 2022