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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-03216 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This study evaluates whether tumors present in patients with cancer who are planned to get CAR T-cells have low amounts of oxygen (hypoxia). PET scans may be used to check the amounts of oxygen within areas of cancer with a special radioactive tracer called FAZA that specifically looks for areas of low oxygen. This study is being done to help researchers determine how the amount of oxygen within areas of cancer affect how well CAR T-cells kill cancer cells.
PRIMARY OBJECTIVE:
I. To evaluate the incidence of intratumoral hypoxia in patients with relapsed or refractory (R/R) malignancies before treatment with chimeric antigen receptor (CAR) T-cell therapy.
SECONDARY OBJECTIVE:
I. To evaluate the association between intratumoral hypoxia and clinical responses to CAR T-cell therapy.
EXPLORATORY OBJECTIVES:
I. To correlate intratumoral hypoxia with markers of CAR T-cell activity and toxicity.
2. To correlate pre-therapy fluorine F 18-fluoroazomycin arabinoside (18F-FAZA) uptake with pre-therapy 18Ffluorodeoxyglucose (FDG) positron emission tomography (PET) uptake (if available).
OUTLINE:
Prior to CAR T-cell therapy, patients receive 18F-FAZA intravenously (IV). Beginning 2 hours after injection, patients undergo a single PET scan. Patients are followed for up to 6 months after CAR T-cell therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (18F-FAZA PET scan) | Prior to CAR T-cell therapy, patients receive administration of 18F-FAZA IV. Patients will then undergo a vertex-thigh PET scan approximately 2 hours after injection of 18FFAZA lasting 30-45 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorine F 18-fluoroazomycin Arabinoside | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of fluorine F 18-fluoroazomycin arabinoside (18F-FAZA) positron emission tomography (PET) scans with positive hypoxic volume (HV) | Will calculate the uniformly minimum-variance unbiased estimator, p-value and 95% confidence interval (CI) for the response rates. | After completion of one-time 18F-FAZA PET scan, 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response (OR) | Will determine OR at any time point as attainment of either complete response (CR) or partial response (PR). Logistic regressions will be used to evaluate the association between OR and intratumoral hypoxia, where hypoxia is analyzed as a binary and a continuous covariate. | At 30, 90, and 180 days after chimeric antigen receptor (CAR) T-cell therapy, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Serum Ferritin levels | Will use descriptive statistical methods to present data, including frequencies/percentages for categorical variables and means, medians, standard deviations, and ranges for continuous variables. Will evaluate the effect of intratumoral hypoxia and other exploratory endpoints using chi-squared tests and logistic regressions for categorical variables and two-sample t-tests and linear regressions for continuous variables. |
Inclusion Criteria:
Histologically confirmed diagnosis of:
R/R disease with planned receipt of CAR T-cell therapy at University of California, San Francisco (UCSF), either through an Food and Drug Administration-approved CAR construct or through a separate interventional clinical trial
Ability to provide informed consent prior to study entry
Exclusion Criteria:
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Patients with relapsed or refractory malignancies who are planning to receive CAR T-cell therapy at University of California, San Francisco (UCSF)
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| Name | Affiliation | Role |
|---|---|---|
| C. Babis Andreadis, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37300573 | Derived | Banerjee R, Wang V, Huang CY, Pandita D, Leonard MK, LaRue S, Ahmadi M, Kaplan L, Ai WZ, Fakhri B, Spinner M, Seshadri MR, Pampaloni MH, Andreadis CB. Hypoxia-specific imaging in patients with lymphoma undergoing CAR-T therapy. Eur J Nucl Med Mol Imaging. 2023 Sep;50(11):3349-3353. doi: 10.1007/s00259-023-06296-z. Epub 2023 Jun 10. |
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| Positron Emission Tomography | Procedure | Undergo PET scan |
|
|
| Up to 6 months after CAR T-cell therapy |
| Change in Mean C-reactive protein (CRP) levels | Will use descriptive statistical methods to present data, including frequencies/percentages for categorical variables and means, medians, standard deviations, and ranges for continuous variables. Will evaluate the effect of intratumoral hypoxia and other exploratory endpoints using chi-squared tests and logistic regressions for categorical variables and two-sample t-tests and linear regressions for continuous variables. | Up to 6 months after CAR T-cell therapy |
| Change in Mean Fibrinogen Levels | Will use descriptive statistical methods to present data, including frequencies/percentages for categorical variables and means, medians, standard deviations, and ranges for continuous variables. Will evaluate the effect of intratumoral hypoxia and other exploratory endpoints using chi-squared tests and logistic regressions for categorical variables and two-sample t-tests and linear regressions for continuous variables. | Up to 6 months after CAR T-cell therapy |
| Change in Hepatic aminotransferase Levels | Will use descriptive statistical methods to present data, including frequencies/percentages for categorical variables and means, medians, standard deviations, and ranges for continuous variables. Will evaluate the effect of intratumoral hypoxia and other exploratory endpoints using chi-squared tests and logistic regressions for categorical variables and two-sample t-tests and linear regressions for continuous variables. | Up to 6 months after CAR T-cell therapy |
| Incidence of cytokine release syndrome (CRS), neurotoxicity, or other adverse events (AEs) attributed to CAR T-cell therapy | Will use descriptive statistical methods to present data, including frequencies/percentages for categorical variables and means, medians, standard deviations, and ranges for continuous variables. Will evaluate the effect of intratumoral hypoxia and other exploratory endpoints using chi-squared tests and logistic regressions for categorical variables and two-sample t-tests and linear regressions for continuous variables. | Up to 6 months after CAR T-cell therapy |
| Standardized uptake value maximum (SUVmax) calculations for tumor sites based on 18F-FAZA versus fludeoxyglucose F-18 (18F-FDG) uptake | Will use descriptive statistical methods to present data, including frequencies/percentages for categorical variables and means, medians, standard deviations, and ranges for continuous variables. Will evaluate the effect of intratumoral hypoxia and other exploratory endpoints using chi-squared tests and logistic regressions for categorical variables and two-sample t-tests and linear regressions for continuous variables. | Up to 6 months after CAR T-cell therapy |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| C498052 | fluoroazomycin arabinoside |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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