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

ConditionNon-hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 providing there is CNS involvement on MRI compatible with PCNSL

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 dose methotrexate, ibrutinib and rituximab as per protocol

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).

Disqualifiers

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 efficacy assessment of the investigational regimen are eligible for this trial. However, patients on active anticancer therapy for other advanced or metastatic malignancies are not eligible.

Patients with a known hypersensitivity to the study drugs or their components

Trial design

Design model

Single group

Treatments tested in this trial

  • Methotrexate

    Drug

    3.5mg/m2 IV

  • Rituximab (where available)

    Drug

    375mg/m2 / 1400mg IV or SC

  • Ibrutinib

    Drug

    Dose and schedule assigned at enrollment

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Methotrexate, Ibrutinib +/- RituximabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

One year progression-free survival (PFS)

Time frame
5 years

Secondary outcomes

1

Overall Response Rate (ORR = CR+CRu+PR) and complete response (CR) rate

Time frame
5 years
2

1-year event-free survival (EFS)

Time frame
5 years
3

2-year progression-free survival

Time frame
5 years
4

Overall survival (OS)

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

Janssen Inc.

Collaborator

Source ClinicalTrials.gov
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