iNNOVATE Study: A study of ibrutinib or placebo with rituximab
Research type
Research Study
Full title
iNNOVATE Study: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination with Rituximab in Subjects with Waldenström’s Macroglobulinemia
IRAS ID
178036
Contact name
Shirley D'Sa
Contact email
Sponsor organisation
Pharmacyclics, Incorporated
Eudract number
2013-005478-22
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
102,688, IND Number
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
Waldenströms Macroglobulinemia (WM) is a rare cancer of the white blood cells (called lymphocytes) that is associated with the overproduction of proteins called IgM antibodies. It is incurable and has a varied outcome. Symptoms can include anaemia and reduction of other normal blood cells. There can be symptoms relating to the hyperviscosity of blood from the elevated IgM.
Ibrutinib is the first FDA approved treatment for WM (approved Jan 2015). Current treatments are those used for other blood cancers and include rituximab alone or in combination with chemotherapy. These treatments however, do not target disease specific abnormalities and are associated with treatment related side effects which may be life threatening. There is limited data available for salvage therapies and few treatments available for relapsed or refractory WM.
The purpose of the study sponsored by Pharmacyclics, Inc is to investigate the use of two study drugs: ibrutinib and rituximab in patients with WM. The safety and how well the drug is tolerated will be determined based on physical exams, laboratory tests, bone marrow biopsies, scans and questions about any problems the participant might experience in the study.
Approximately 180 participants will take part at approximately 65 sites globally. Participation will last approximately 4 years. Participants will be required to visit the clinic at different time points depending on how long they stay in the study. After the treatment ends they will be followed up every 12 weeks.
Participants will be randomized to receive one of the following:
Group A will receive ibrutinib oral capsules in combination with rituximab intravenously.
Group B will receive placebo oral capsules in combination with rituximab intravenously. Subjects in this group will have access to next-line ibrutinib after centrally confirmed disease progression.
Group C receive ibrutinib oral capsules only. (enrolment in this group is now closed).
Neither the participant nor the study doctor will know what treatment is assigned if group A or B. Group C is open label.REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0967
Date of REC Opinion
2 Aug 2015
REC opinion
Further Information Favourable Opinion