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Rituximab With or Without Ibrutinib for Patients With Advanced Follicular Lymphoma

NCT02451111 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-03-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ibrutinib

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.

DRUG

Rituximab

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.

Sponsors & Collaborators

  • Nordic Lymphoma Group

    collaborator NETWORK

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Emanuele Zucca, Prof · Oncology Institute of Southern Switzerland IOSI, Bellinzona

  • Bjørn Østenstad, MD · Oslo University Hospital

  • Björn Wahlin, MD · Karolinska University Hospital, Stockholm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-06
Primary Completion
2022-12-01
Completion
2023-07-15

Countries

  • Austria
  • Denmark
  • Finland
  • Norway
  • Sweden
  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02451111 on ClinicalTrials.gov