Clinical Trial: NCT02947347 - My Cancer Genome

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:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02947347

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

Follicular Lymphoma

Interventions

Drug	Synonyms	Arms
ibrutinib	Imbruvica	(Part 1 : Arm A) ibrutinib + rituximab
placebo to match ibrutinib		(Part 1 : Arm B) placebo + rituximab
rituximab		(Part 1 : Arm A) ibrutinib + rituximab
ibrutinib	Imbruvica	(Part 2 : Arm A1) ibrutinib
placebo to match ibrutinib		(Part 2 : Arm A2) placebo

Purpose

Trial Arms

Name	Type	Description	Interventions
(Part 1 : Arm A) ibrutinib + rituximab	Experimental	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	ibrutinib rituximab
(Part 1 : Arm B) placebo + rituximab	Placebo Comparator	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	placebo to match ibrutinib rituximab
(Part 2 : Arm A1) ibrutinib	Experimental	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	ibrutinib
(Part 2 : Arm A2) placebo	Placebo Comparator	Subjects 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

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:

Secondary Outcome Measures

Measure:	Overall Response Rate (ORR)
Time Frame:	2-5 years
Safety Issue:
Description:	Part 1

Measure:	Overall Survival
Time Frame:	2-5 years
Safety Issue:
Description:	Part 1

Measure:	Infusion-Related Reaction Rate
Time Frame:	2-5 years
Safety Issue:
Description:	Arm A vs. Arm B (Part 1)

Measure:	Adverse Events
Time Frame:	2-5 years
Safety Issue:
Description:

Details

Phase:	Phase 3
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Pharmacyclics LLC.

Last Updated

July 21, 2021

Clinical Trials /

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma