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CD5+ B Cell Monitoring for Vasculitis

N/A

Waitlist Available

Led By Vimal Derebail, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Patients must be in complete remission for at least 1 month and after AT LEAST 3 MONTHS of induction of therapy with corticosteroids and rituximab (either 1000 mg IV x 2 or 375 mg/m2 IV x 4) OR corticosteroids and cyclophosphamide (monthly IV or daily oral doses). They must be on no more than 5 mg daily of oral prednisone or equivalent. Complete remission is defined as a BVAS score = 0

ANCA Glomerulonephritis (GN) or vasculitis per Chapel Hill Consensus Criteria, with documented current or previously positive Myeloperoxidase (MPO)- or Proteinase 3 (PR3)-ANCA by ELISA test

Must not have

Active tuberculosis, human immunodeficiency virus (HIV), hepatitis C virus or hepatitis B virus infections

Patients with drug-induced ANCA vasculitis (e.g. levamisole-adulterated cocaine)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from remission to end of study, approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a certain type of B cell is associated with decreased risk of relapse in ANCA vasculitis, and whether patients with this type of B cell can be monitored conservatively without further immunotherapy.

Who is the study for?

Adults aged 18-85 with ANCA vasculitis, a condition where antibodies damage blood vessels, can join if they've had successful initial treatment and are in remission. They must have some B cells recovered but can't participate if they have certain infections, multiple relapses of vasculitis, or are pregnant.

What is being tested?

The trial is testing whether patients with ANCA vasculitis who recover a specific type of B cell (CD5+) after initial therapy need ongoing treatment. Some will get more immunotherapy (rituximab), while others will just be closely watched without further medication.

What are the potential side effects?

Rituximab may cause infusion reactions, infections due to immune system suppression, skin rashes, and potentially serious heart problems. Azathioprine and mycophenolate mofetil might lead to similar issues like increased infection risk and liver or bone marrow problems.

Eligibility Criteria

Inclusion Criteria

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

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I've been in complete remission for over a month after treatment with specific drugs and am on a low dose of steroids.

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I have kidney inflammation or blood vessel inflammation due to ANCA, confirmed by a positive MPO or PR3 test.

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My kidney inflammation is confirmed by biopsy and I tested positive for ANCA.

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My B cells have recovered to a level that allows for further testing.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active tuberculosis, HIV, or hepatitis.

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My vasculitis was caused by drug use, such as levamisole-adulterated cocaine.

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I cannot attend all scheduled appointments.

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I have not had any serious infections in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to end of study, approximately 2.5 to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to end of study, approximately 2.5 to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of study, approximately 2.5 to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time to First Relapse

Secondary study objectives

Frequency of Infections

Frequency of Relapse

Number of Infections, categorized by severity

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: high CD5 / NO maintenanceExperimental Treatment1 Intervention

Subjects in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)

Group II: low CD5+ /on maintenanceActive Control1 Intervention

Subjects in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.

Group III: high CD5/ on maintenanceActive Control1 Intervention

Subjects in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)

0 / 9Eligibility criteria met