Rituximab With or Without Ibrutinib for Patients With Advanced Follicular Lymphoma

Sponsor
Swiss Cancer Institute
Study ID
NCT02451111
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Patients will be instructed by the Investigator to take the amount of 560 mg Ibrutinib/Placebo (4 x 140 mg capsules) orally once daily with a glass of water at approximately the same time every day.
  • Rituximab — DRUG
    Rituximab 375 mg/m2 has to be administered i.v. for the first four (4) infusions in all patients. After i.v. administration of Rituximab for the induction therapy, the administration mode can be changed to s.c. (1400 mg) in the maintenance phase dependent on the local standard of care.

Study Details

Follicular lymphomas FL has been traditionally approached either by an initial watch and wait policy in the asymptomatic patient, or with single agent treatments with the purpose of maintaining a good quality of life for a prolonged time.The combination of rituximab and ibrutinib has been tested in clinical trials and appeared to be well tolerated and active. Since ibrutinib seems to achieve better results when administered for prolonged time as shown in CLL, the investigators have chosen to compare its combination with rituximab to the prolonged rituximab-only schedule that was already shown to be very active in the SAKK 35/03 trial. The aim of the study is to investigate the efficacy, safety and tolerability of the treatment combination of Ibrutinib and Rituximab for patients with advanced follicular lymphoma in need of therapy.

Key Dates

Start date
Nov 6, 2015
Status verified
Mar 2024
Primary completion
Dec 1, 2022
Completion
Jul 15, 2023

Study Design

Enrollment
190 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab/Ibrutinib
    Ibrutinib capsules for 24 months (104 weeks) daily (always at the same time) in a dose of 560 mg (4 x 140 mg capsules)
  • Placebo Comparator: Rituximab/Placebo
    Placebo as comparator for 24 months (4 capsules daily always at the same time)

Primary Outcome Measure

CR at 24 months determined by PET/CT scan by the IRR panel [ Time Frame: at 24 months ]

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