Purpose

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

Eligibility

Eligible Ages
Over 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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 names:
    • 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
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
  • Drug: placebo to match ibrutinib
    placebo capsules to match ibrutinib administered orally

Recruiting Locations

Tulane Medical Center
New Orleans, Louisiana

More Details

NCT ID
NCT02947347
Status
Recruiting
Sponsor
Pharmacyclics LLC.

Study Contact

Silvie Aarts
+1- 669- 224- 1860
medinfo@pcyc.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.