Actively Recruiting
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Led by Canadian Cancer Trials Group · Updated on 2026-04-14
30
Participants Needed
8
Research Sites
254 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
J
Janssen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is being done to answer the following question: Can the addition of a new drug to the usual treatment lower the chance of primary central nervous system lymphoma growing or spreading? This study is being done to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as the care most people get for Primary Central Nervous System Lymphoma (PCNSL).
CONDITIONS
Official Title
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histological or cytological evidence of primary central nervous system lymphoma (PCNSL) or CNS involvement on MRI
- Patients must be 18 years of age or older
- Patients must be ineligible for high-dose chemotherapy and stem cell transplantation due to age (≥65 years) or comorbidities but fit for treatment
- Patients must consent to release a tumour block specimen if available
- Presence of radiologically documented disease or residual disease planned for standard care methotrexate/rituximab
- No prior systemic therapy except one cycle of methotrexate with or without rituximab within 4 weeks before enrollment
- Corticosteroid use limited to dexamethasone 8mg/day or less and tapered off within 7 days of starting study treatment
- Intrathecal therapy at diagnostic lumbar puncture allowed without washout
- Previous major surgery allowed if at least 28 days prior and wound healed; brain biopsy/resection allowed when safe
- No prior radiation therapy for PCNSL
- ECOG performance status 0-2, or 3 if due to PCNSL and expected to improve
- Ability to swallow oral medications and no gastrointestinal disorders interfering with absorption
- Adequate organ and marrow function within 7 days prior to enrollment
- Ability and willingness to complete quality of life questionnaires in English or French
- Accessibility for treatment and follow-up at participating center
- Treatment to begin within 2 working days of enrollment
- Women/men of childbearing potential must agree to use effective contraception
You will not qualify if you...
- Patients with secondary central nervous system non-Hodgkin lymphoma
- Significant pleural effusions or ascites not drained before methotrexate
- Active anticancer therapy for other advanced or metastatic malignancies
- Known allergy to study drugs or components
- Active uncontrolled infection within 7 days prior to enrollment
- HIV with CD4 count less than 350 cells/microliter or uncontrolled HIV
- Serious illnesses preventing protocol management
- Concurrent anti-cancer or investigational treatments during protocol therapy
- Prior allogenic bone marrow transplant or double umbilical cord blood transplantation
- Pregnant or breastfeeding women
- Need for anticoagulation with warfarin or equivalent vitamin K antagonists
- Need for therapy with strong CYP3A inhibitors or inducers
- Corticosteroid treatment over 8mg dexamethasone at enrollment
- Use of supplements containing fish oil or vitamin E, or grapefruit juice
- Live attenuated vaccination within 30 days before enrollment or pre-study methotrexate
- Significant cardiac disease including recent myocardial infarction, heart failure, uncontrolled hypertension, or arrhythmias (except controlled atrial fibrillation)
- Baseline left ventricular ejection fraction below 50% if clinically significant cardiac history
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
2
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
3
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
4
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
5
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
6
The Research Institute of the McGill University
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
7
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
8
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Actively Recruiting
Research Team
A
Annette Hay
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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