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New treatment option for Non-hodgkin Lymphoma
Official title Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
ClinicalTrials.gov ID: NCT05998642
What this study is testing
What is Methotrexate?
Methotrexate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histological or cytological evidence of primary central nervous system (CNS) lymphoma (PCNSL); patients with vitreo-retinal...
- Patients must be 18 years of age or older
- Patients must be ineligible (≥65 years old or comorbidities) for high-dose chemotherapy and autologous stem cell transplantation. Patients must be...
- Patients must have consented to the release of a tumour block from their brain tumour, if available (see Section 12.0). The centre/pathologist must...
- Presence of radiological documented disease. Patients believed to have residual disease following a complete resection, even if radiology is negative...
You likely can't join if
- Patients with secondary central nervous system non-Hodgkin lymphoma (NHL).
- Patients with significant third space accumulation (pleural effusions, ascites) which cannot be adequately drained in advance of methotrexate...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how...
- Patients with a known hypersensitivity to the study drugs or their components
- Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior to enrollment. Patients with hepatitis B serology suggestive of past...
- They have received antiretroviral therapy for at least 4 weeks prior to enrollment, and the anti-viral drugs used are not known to have clinically...
See the full eligibility criteria
Who can join
- Patients must have histological or cytological evidence of primary central nervous system (CNS) lymphoma (PCNSL); patients with vitreo-retinal lymphoma (NHL) or cerebrospinal fluid (CSF) positive disease are eligible...
- Patients must be 18 years of age or older
- Patients must be ineligible (≥65 years old or comorbidities) for high-dose chemotherapy and autologous stem cell transplantation. Patients must be considered fit, as determined by the treating physician, to receive high...
- Patients must have consented to the release of a tumour block from their brain tumour, if available (see Section 12.0). The centre/pathologist must have agreed to the submission of the specimen(s).
- Presence of radiological documented disease. Patients believed to have residual disease following a complete resection, even if radiology is negative or equivocal, are eligible provided they are planned for standard of...
- No prior systemic therapy other than the following situations:
- Methotrexate +/- rituximab: Patients may have received one cycle of methotrexate with or without rituximab as standard of care therapy, but must be enrolled no longer than 4 weeks after first dose of methotrexate...
- Use of corticosteroids (topical are permitted) on study (except for short-term treatment of infusion reactions and nausea prophylaxis) is not permitted. Patients receiving corticosteroids me be eligible, providing:
- they are receiving not more than dexamethasone 8mg/day (or equivalent)
- The corticosteroid will be tapered and completely discontinued within 7 days of starting the study protocol treatment. Patients who would require continued or concurrent treatment with systemic steroids are not eligible.
- Intrathecal therapy: Patients may have received intrathecal therapy at the time of diagnostic lumbar puncture. No washout period is needed prior to enrollment.
- Previous major surgery is permitted provided that surgery occurred at least 28 days prior to patient enrollment and that wound healing has occurred. The 28 day cut-off does not apply to surgery for PCNSL; treatment may...
- No prior radiation therapy for PCNSL is allowed
- ECOG performance status 0-2, and ECOG 3 permitted if secondary to primary CNS lymphoma and expected to reverse with treatment
- Patients must be able to swallow oral medications and have no known gastrointestinal disorders that may interfere with absorption (such as malabsorption).
- Patients must have adequate organ and marrow function measured within 7 days prior to enrollment including: Absolute neutrophils ≥ 1.0 x 10\^9/L (independent of growth factor support); Platelets ≥ 75 x 10\^9/L...
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or French
- Patients must be accessible for treatment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre
- In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
What rules you out
- Patients with secondary central nervous system non-Hodgkin lymphoma (NHL).
- Patients with significant third space accumulation (pleural effusions, ascites) which cannot be adequately drained in advance of methotrexate administration
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients with a known hypersensitivity to the study drugs or their components
- Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior to enrollment. Patients with hepatitis B serology suggestive of past infection (for example anti-HB-c positive but HBsAG and anti-HBs...
- They have received antiretroviral therapy for at least 4 weeks prior to enrollment, and the anti-viral drugs used are not known to have clinically relevant drug-drug interactions with ibrutinib AND
- HIV viral load must be \< 400 copies/ml within 16 weeks prior to enrollment AND No history of opportunistic infections within the past year
- Serious illnesses or medical conditions which would not permit the patient to be managed according to protocol
- Patients may not receive concurrent treatment with other anti-cancer therapy or investigational agents while on protocol therapy
- Patients with prior allogenic bone marrow transplant or double umbilical cord blood transplantation.
- Pregnant or breastfeeding women
- Patients requiring:
- Anticoagulation with warfarin or equivalent vitamin K antagonists
- Continued requirement for therapy with a strong CYP3A inhibitor or inducer (see trial webpage for list)
- Corticosteroid treatment with \> 8mg of dexamethasone (or equivalent) at the time of enrollment
- Supplements containing fish oil or vitamin E, and grapefruit juice should be avoided
- Live attenuated vaccination administered within 30 days prior to enrollment
- Patients with clinically significant cardiac disease, including:
- angina pectoris, symptomatic pericarditis, coronary artery bypass grafting, coronary angioplasty, or stenting, or myocardial infarction in the previous 12 months;
- history of documented congestive heart failure (New York Heart Association functional classification III-IV) or cardiomyopathy;
- uncontrolled hypertension (per Canadian guidelines);
- atrial or ventricular arrhythmias; patients with controlled atrial fibrillation are eligible
- Patients with distant clinically significant cardiac history should have a LVEF ≥ 50% Baseline LVEF is not required for patients with only a cardiac history of hypertension which is now controlled.
- Patients may not receive concurrent treatment with other anti-cancer therapy or investigational agents while on protocol therapy.
- Patients with prior allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- Pregnant or breastfeeding women.
- Patients requiring:
- Anticoagulation with warfarin or equivalent vitamin K antagonists
- Continued requirement for therapy with a strong CYP3A inhibitor or inducer
- Corticosteroid treatment with \> 8mg of dexamethasone (or equivalent) at the time of enrollment
- Supplements containing fish oil or vitamin E, and grapefruit juice should be avoided.
- Live attenuated vaccination administered within 30 days prior to enrollment, or within 30 days prior to start date of pre-study methotrexate +/- rituximab for participants who receive one cycle before enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Regina, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.