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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: ibrutinib Drug: placebo to match ibrutinib Drug: rituximab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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

 Drug: ibrutinib
ibrutinib 560mg administered orally
Other Name: Imbruvica

Drug: rituximab
rituximab 375mg/m^2 IV
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

 Drug: placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally

Drug: rituximab
rituximab 375mg/m^2 IV
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

 Drug: ibrutinib
ibrutinib 560mg administered orally
Other Name: Imbruvica
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

 Drug: placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2-5 years ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 2-5 years ]
    Part 1

  2. Overall Survival [ Time Frame: 2-5 years ]
    Part 1

  3. Infusion-Related Reaction Rate [ Time Frame: 2-5 years ]
    Arm A vs. Arm B (Part 1)

  4. Adverse Events [ Time Frame: 2-5 years ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947347


Locations
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Sponsors and Collaborators
Pharmacyclics LLC.
More Information
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Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02947347    
Other Study ID Numbers: PCYC-1141-CA
2016-003202-14 ( EudraCT Number )
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents