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Kinase Inhibitor

Methotrexate, Ibrutinib +/- Rituximab for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Research Sponsored by Canadian Cancer Trials Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 dose methotrexate, ibrutinib and rituximab as per protocol

No prior systemic therapy other than corticosteroids for PCNSL is permitted. Use of corticosteroids to control symptoms of PCNSL is allowed, but the patient must be on a maximum dose of dexamethasone 8mg/day (or equivalent) or less at the time of enrolment. Patients must wean off the steroids within 7 days of starting the study protocol treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is researching if adding a new drug to the usual treatment for PCNSL can reduce its growth or spread.

Who is the study for?

This trial is for individuals over 18 with newly diagnosed primary CNS lymphoma who can't have a stem cell transplant due to age or other health issues. They should be able to take high-dose methotrexate, ibrutinib, and rituximab, and not have had previous treatments except steroids. Participants need proper organ function and must be able to swallow pills without absorption problems.Check my eligibility

What is being tested?

The study tests if adding Ibrutinib to the usual treatment (Rituximab and Methotrexate) is more effective in treating primary CNS lymphoma. It compares this new combination against the standard care most people receive for this type of cancer.See study design

What are the potential side effects?

Possible side effects include reactions related to Rituximab infusion, liver issues from Methotrexate, bleeding risks, infections due to weakened immune system from Ibrutinib, as well as general fatigue and digestive disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 65 or have health issues that prevent me from undergoing high-dose chemotherapy and stem cell transplant, but can still receive specific treatments.

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I have only used corticosteroids for my brain lymphoma and am on a low dose.

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My blood tests show normal organ function and I have no serious blood or liver issues.

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I am 18 years old or older.

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I can take pills and don't have issues absorbing food or medicine.

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I have agreed to provide a sample of my brain tumor for research.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

One year progression-free survival (PFS)

Secondary outcome measures

1-year event-free survival (EFS)

2-year progression-free survival

Number and severity of adverse events

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Methotrexate, Ibrutinib +/- RituximabExperimental Treatment3 Interventions

Cycles 1-6, q14 days Day 1: Methotrexate + Rituximab Days 6-14: Ibrutinib daily orally

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 3

~1880

Methotrexate

2013

Completed Phase 4

~3800

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Inc.Industry Sponsor

23 Previous Clinical Trials

8,051 Total Patients Enrolled

Canadian Cancer Trials GroupLead Sponsor

124 Previous Clinical Trials

67,423 Total Patients Enrolled

Anca PricaStudy ChairUniversity Health Network-Princess Margaret Hospital, Toronto, ON Canada

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks exist with administering a combination of Methotrexate, Ibrutinib and Rituximab?

"There is some evidence of safety for the combination therapy of Methotrexate, Ibrutinib +/- Rituximab; thus it was provided a rating of 2. Phase 2 trials do not include data to support efficacy."

Answered by AI

What is the approximate size of the cohort participating in this research?

"Affirmative. The information on clinicaltrials.gov demonstrates that this medical research, first posted in November 30th 2023, is currently recruiting patients. Approximately thirty persons must be enrolled from 3 different healthcare facilities."

Answered by AI

Are there any opportunities for individuals to partake in this research?

"Affirmative. The information hosted on clinicaltrials.gov suggests that this trial is still searching for volunteers, having been first posted to the database on November 30th 2023 and last updated December 11th 2023. A total of 30 patients are being recruited from 3 different research sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma

2024. "Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05998642.