Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT02947347

Recruitment Status : Recruiting

First Posted : October 27, 2016

Last Update Posted : July 10, 2020

See Contacts and Locations

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

July 10, 2020

Study Start Date ^ICMJE

January 2017

Estimated Primary Completion Date

January 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-free survival [ Time Frame: 2-5 years ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

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
Placebo Comparator: (Part 2 : Arm B) placebo
Subjects will receive placebo

Part 1 Arm B subjects will be re-randomized into Part 2 Arm B

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

Recruiting

Estimated Enrollment ^ICMJE

440

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

January 2025

Estimated Primary Completion Date

January 2022 (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

Contacts ^ICMJE

Contact: Silvie Aarts

+1- 669- 224- 1860

medinfo@pcyc.com

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

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Pharmacyclics LLC.

Study Sponsor ^ICMJE

Pharmacyclics LLC.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Pharmacyclics LLC.

Verification Date

July 2020

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

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