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Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02947347
Recruitment Status : Active, not recruiting
First Posted : October 27, 2016
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics LLC.

Tracking Information
First Submitted Date  ICMJE October 26, 2016
First Posted Date  ICMJE October 27, 2016
Last Update Posted Date September 9, 2022
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
Progression-free survival [ Time Frame: 2-5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 20, 2021)
431
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2016)
440
Estimated Study Completion Date  ICMJE June 2026
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Czechia,   France,   Greece,   Hungary,   Israel,   Italy,   Netherlands,   New Zealand,   Poland,   Portugal,   Russian Federation,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02947347
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party Pharmacyclics LLC.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pharmacyclics LLC.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pharmacyclics LLC.
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP