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Monoclonal Antibodies

Rituximab for EBV Infection

Phase 1 & 2

Waitlist Available

Led By Deepali Kumar

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-transplant

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing whether giving the donor lungs a dose of rituximab can decrease the amount of B-cells and EBV in the graft, which may prevent the EBV from being transmitted to the patient.

Eligible Conditions

Epstein-Barr Virus (EBV) Infection
Epstein-Barr Virus Infection
Lymphoproliferative Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with Primary Graft Dysfunction

Secondary study objectives

Number of patients with plasma EBV viral load of >=10,000 copies/mL

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Rituximab + Ex-vivo lung perfusionExperimental Treatment1 Intervention

Donor lungs deemed suitable for such patients will undergo ex vivo lung perfusion (EVLP) as per standard practice. In clinical practice almost all adult donor lungs are EBV seropositive. If in the rare case the donor lung is EBV seronegative, then the lung transplant candidate/recipient will no longer need to be part of the study. Therefore, for EBV seropositive lungs meant for an EBV seronegative recipient, one dose of rituximab (500mg) will be added to the EVLP perfusate and be allowed to circulate for 3-4 hours. Lungs will then be transplanted as per standard procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

FDA approved

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