IVIG for Infection Prevention After Lymphoma Treatment

Phase 2

Recruiting

Led By Joshua Hill

Research Sponsored by Fred Hutchinson Cancer Center

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 at 6 months post cartx

Summary

This trial tests if immunoglobulin replacement therapy can help prevent infections in patients getting CD19 CAR-T cell therapy.

Who is the study for?

This trial is for adults with lymphoma who are getting FDA-approved CD19-CAR T-cell therapy and have low levels of IgG antibodies. They must understand the study's risks and benefits, give informed consent, or have a legal representative do so if they're unable to. People with past IVIG issues, serious allergies to IVIG components, or conditions that could risk their safety or skew results can't join.

What is being tested?

The trial is testing whether giving immunoglobulin replacement therapy (IVIG) after CAR-T cell treatment can prevent infections better than a placebo. Participants will either receive human immune globulin infusions or saline as a control while being monitored through surveys and health record reviews.

What are the potential side effects?

Potential side effects include reactions related to immune globulin infusion such as headache, nausea, fatigue, allergic reactions, and in rare cases more severe responses like blood clots or kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months post cartx

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months post cartx

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months post cartx for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence rate of serious bacterial infections in the modified intention-to-treat (mITT) population

Secondary study objectives

CAR T-cell expansion: Peak Plasma Concentration (Cmax)

CAR T-cell expansion: area under the curve (AUC)

CAR T-cell persistence

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (therapeutic immune globulin)Experimental Treatment5 Interventions

Patients receive IGRT with IVIG within 14 days prior to CD19 CAR-T treatment. Patients then undergo CD19 CAR-T therapy. Patients receive IVIG monthly, starting 28 days after CD19 CAR-T therapy for 4 months in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout the study.

Group II: Arm II (normal saline)Placebo Group5 Interventions

Patients receive placebo with normal saline IV within 14 days prior to CD19 CAR-T treatment. Patients then undergo CD19 CAR-T therapy. Patients receive normal saline monthly, starting 28 days after CD19 CAR-T therapy for 4 months in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

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