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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
Age >=18 years
Listed for single or double lung transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-transplant
Awards & highlights

Study 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
  • Lymphoproliferative Disorder

Eligibility Criteria

Inclusion Criteria

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

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with Primary Graft Dysfunction
Secondary outcome measures
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
4%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab

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

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,863 Total Patients Enrolled
Deepali KumarPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
229 Total Patients Enrolled

Frequently Asked Questions

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

What are some of the primary indications for Rituximab?

"Rituximab is an effective treatment for diffuse large b-cell lymphoma (dlbcl), b-cell lymphomas, and polyangium."

Answered by AI

Are there any current openings in this trial for eligible participants?

"That is accurate, the clinical trial detailed on clinicaltrials.gov is currently looking for subjects. The date the study was first posted was July 7th, 2020 with the most recent update being from July 29th, 2022. There is a need for 10 individuals at 1 location."

Answered by AI

How many people are being included in this research project?

"The clinicaltrial.gov website has information revealing that this study is looking for 10 participants at 1 sites. The trial was first posted on 7/7/2020 and was most recently edited on 7/29/2022."

Answered by AI
~2 spots leftby Mar 2025