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CAR T-cell Therapy
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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence rate of serious bacterial infections in the modified intention-to-treat (mITT) population
Secondary outcome measures
CAR T-cell expansion: Peak Plasma Concentration (Cmax)
CAR T-cell expansion: area under the curve (AUC)
CAR T-cell persistence
+8 moreTrial 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 2
~1700
Find a Location
Who is running the clinical trial?
TakedaIndustry Sponsor
1,203 Previous Clinical Trials
4,177,794 Total Patients Enrolled
45 Trials studying Lymphoma
13,730 Patients Enrolled for Lymphoma
Fred Hutchinson Cancer CenterLead Sponsor
557 Previous Clinical Trials
1,343,365 Total Patients Enrolled
100 Trials studying Lymphoma
6,387 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,291 Total Patients Enrolled
1,383 Trials studying Lymphoma
382,251 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received an FDA-approved CAR T-cell therapy for lymphoma.I will receive an FDA-approved CAR T-cell therapy for lymphoma.If I'm unable to consent, my legal representative will sign for me.I have a condition where my body lacks enough IgA antibodies.I have received a bone marrow transplant.I am 18 years old or older.I have received more treatment because my cancer came back or didn't fully go away.I am experiencing severe symptoms from my immune therapy.I have not experienced any severe side effects or new illnesses that would make continuing treatment unsafe for me.I understand the study's risks and benefits and can give informed consent.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (therapeutic immune globulin)
- Group 2: Arm II (normal saline)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Arm I (therapeutic immune globulin) a secure medication for people to consume?
"Safety data gathered by our team at Power indicates that Arm I (therapeutic immune globulin) is safe enough to be given a score of 2, as this trial has only reached Phase 2 and the efficacy of said treatment has yet to be established."
Answered by AI
Are there still opportunities for participation in this experiment?
"Clinicaltrials.gov currently states that this trial is not enrolling patients, despite its initial posting on December 1st 2023 and last update on July 17th 2023. However, there are still over 1700 other trials actively recruiting participants at the present moment."
Answered by AI
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