IVIG for Infection Prevention After CAR-T-Cell Therapy

Part of paid clinical trials in Duarte, California.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT05952804
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Immune Globulin Infusion (Human), 10% Solution — BIOLOGICAL
    Given IV
  • Anti-CD19 CAR T Cells Preparation — BIOLOGICAL
    Given CAR-T treatment
  • Saline — OTHER
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Survey Administration — OTHER
    Ancillary studies
  • Electronic Health Record Review — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jun 10, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm I (therapeutic immune globulin)
    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.
  • Placebo Comparator: Arm II (normal saline)
    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.

Primary Outcome Measure

Incidence rate of serious bacterial infections in the modified intention-to-treat (mITT) population [ Time Frame: From randomization through day 168 post chimeric antigen receptor (CAR) T-cell treatment (CARTx) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010
Sanjeet Dadwal, MD (PRINCIPAL_INVESTIGATOR)
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136
Jay Spiegel, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Frederick Locke, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Matthew Frigault, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Miguel-Angel Perales, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science University (OHSU) Knight Cancer InstitutePortlandOregon97239
Amrita Desai, MD, MPH (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Joshua Hill, MD
[email protected]
206-667-6504
Joshua Hill, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope Cancer Center· Duarte, CAUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLMoffitt Cancer Center· Tampa, FLMassachusetts General Hospital Cancer Center· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYOregon Health and Science University (OHSU) Knight Cancer Institute· Portland, OR

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