RECRUITING

IVIG for Infection Prevention After CAR-T-Cell Therapy

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Conditions

Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Immunoglobulin Replacement Therapy and Infectious Complications After CD19-Targeted CAR-T-Cell Therapy

Quick Facts

Study Start:2024-06-10
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05952804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
  2. * 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
  3. * Participants must be 18 years of age or older
  4. * Participants will receive an Food and Drug Administration (FDA)-approved CD19-CAR T-cell product for the treatment of lymphoma. 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)
  5. * Serum total IgG \< 500mg/dL within the prior three months
  6. * SUBSEQUENT INFUSIONS: Received an FDA-approved CD19-CAR T-cell product for the treatment of lymphoma
  1. * Selective IgA deficiency
  2. * Prior serious adverse event/s related to intravenous immune globulin (IVIG) administration
  3. * Known serious allergy to any component of IVIG
  4. * 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
  5. * SUBSEQUENT INFUSIONS: Ongoing symptoms of cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS) meeting criteria for grade 3 or higher
  6. * SUBSEQUENT INFUSIONS: Selective IgA deficiency
  7. * SUBSEQUENT INFUSIONS: 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
  8. * SUBSEQUENT INFUSIONS: Receipt of additional therapy for persistence or relapse of the patient's primary malignancy
  9. * SUBSEQUENT INFUSIONS: Receipt of bone marrow transplant (allogeneic or autologous)
  10. * SUBSEQUENT INFUSIONS: Any serious adverse event (SAE), clinically significant adverse event (AE), severe laboratory abnormality, intercurrent illness, or other medical condition that indicates to the Investigator that continued participation is not in the best interest of the participant

Contacts and Locations

Study Contact

Joshua Hill, MD
CONTACT
206-667-6504
jahill@fredhutch.org

Principal Investigator

Joshua Hill, MD
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

City of Hope Cancer Center
Duarte, California, 91010
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Fred Hutchinson Cancer Center

  • Joshua Hill, MD, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-10
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2024-06-10
Study Completion Date2028-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphoma