Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2024-06-10
2028-07-31
Brief Summary
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Detailed Description
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ARM I: Patients receive immunoglobulin replacement therapy (IGRT) with intravenous immune globulin (IVIG) within 14 days prior to CD19 CAR-T-cell infusion. Patients then undergo CD19 CAR-T therapy. Patients receive IVIG monthly, starting 28 days after CD19 CAR-T therapy for up to 4 months in the absence of unacceptable toxicity, relapse of the underlying disease, or subsequent hematopoietic cell transplant. Patients also undergo blood sample collection throughout the study.
ARM II: Patients receive placebo with normal saline IV within 14 days prior to CD19 CAR-T treatment. Patients then undergo CD19 CAR-T-cell infusion. Patients receive normal saline monthly, starting 28 days after CD19 CAR-T therapy for up to 4 months in the absence of unacceptable toxicity, relapse of the underlying disease, or subsequent hematopoietic cell transplant. Patients also undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up monthly through up to 6 months after CD19 CAR-T-cell infusion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
Immune Globulin Infusion (Human), 10% Solution
Given IV
Anti-CD19 CAR T Cells Preparation
Given CAR-T treatment
Biospecimen Collection
Undergo blood sample collection
Survey Administration
Ancillary studies
Electronic Health Record Review
Ancillary studies
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.
Anti-CD19 CAR T Cells Preparation
Given CAR-T treatment
Saline
Given IV
Biospecimen Collection
Undergo blood sample collection
Survey Administration
Ancillary studies
Electronic Health Record Review
Ancillary studies
Interventions
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Immune Globulin Infusion (Human), 10% Solution
Given IV
Anti-CD19 CAR T Cells Preparation
Given CAR-T treatment
Saline
Given IV
Biospecimen Collection
Undergo blood sample collection
Survey Administration
Ancillary studies
Electronic Health Record Review
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* Serum total IgG \< 600mg/dL within the prior three months
* SUBSEQUENT INFUSIONS: Received an FDA-approved CD19-CAR T-cell product for the treatment of hematologic malignancies
Exclusion Criteria
* 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
* 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
* SUBSEQUENT INFUSIONS: Primary congenital selective IgA deficiency
* 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
* SUBSEQUENT INFUSIONS: Receipt of additional therapy for persistence or relapse of the patient's primary malignancy
* SUBSEQUENT INFUSIONS: Receipt of bone marrow transplant (allogeneic or autologous)
* 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
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Joshua Hill, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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City of Hope Cancer Center
Duarte, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Oregon Health and Science University (OHSU) Knight Cancer Institute
Portland, Oregon, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2023-04889
Identifier Type: REGISTRY
Identifier Source: secondary_id
20082
Identifier Type: OTHER
Identifier Source: secondary_id
RG1123550
Identifier Type: -
Identifier Source: org_study_id
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