IVIG for Infection Prevention After CAR-T-Cell Therapy
ConditionHematologic Malignancies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center
About this trial
This phase II trial compares the effects of immunoglobulin replacement therapy with a placebo for preventing infectious complications in patients receiving CD19 chimeric antigen receptor (CAR)-T cell therapy. Hypogammaglobulinemia is a common complication in patients who receive CD19 CAR-T cell therapy. This is a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high. Immunoglobulin replacement therapy works by replacing the body's immunoglobulin G (IgG) antibodies with donor blood product derived IgG antibodies that may help prevent infection. IgG antibodies are often depleted as a result of CAR-T therapy. Giving immunoglobulin replacement therapy may prevent infectious complications in patients receiving CD19 CAR-T cell therapy.
Eligibility criteria
Qualifiers
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
For patients with medical incapacity or impaired consciousness such that they are not able to give fully informed voluntary consent, the subjects' legal representative must sign an institutional review board (IRB) approved informed consent document prior to the initiation of any screening or study-specific procedures
Participants must be 18 years of age or older
Participants will receive an Food and Drug Administration (FDA)-approved CD19-CAR T-cell product for the treatment of hematologic malignancies. Patients receiving an FDA-approved product are eligible even if the product is being administered as part of a clinical trial or expanded access program (e.g., product is 'out of specification'; concomitant anti-tumor treatment such as acalabrutinib)
Disqualifiers
Primary congenital selective IgA deficiency
Prior serious adverse event/s related to intravenous immune globulin (IVIG) administration
Known serious allergy to any component of IVIG
Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study or interfere with the patient's ability to participate for the full duration of the study or would put the patient at undue risk as judged by the investigator, such that it is not in the best interest of the patient to participate in this study
Trial design
Treatments tested in this trial
- Immune Globulin Infusion (Human), 10% Solution
- Anti-CD19 CAR T Cells Preparation
- Saline
- Biospecimen Collection
- Survey Administration
- Electronic Health Record Review
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fred Hutchinson Cancer Center
Lead sponsor
Takeda
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov