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Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-cell Therapy

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ClinicalTrials.gov Identifier: NCT04409314
Recruitment Status : Suspended (Drug Supply)
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment
Recurrent Aggressive Non-Hodgkin Lymphoma Recurrent Diffuse Large B-Cell Lymphoma Recurrent High Grade B-Cell Lymphoma Recurrent Malignant Neoplasm Recurrent Plasma Cell Myeloma Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma Refractory Aggressive Non-Hodgkin Lymphoma Refractory Diffuse Large B-Cell Lymphoma Refractory High Grade B-Cell Lymphoma Refractory Malignant Neoplasm Refractory Plasma Cell Myeloma Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma Radiation: Fluorine F 18-fluoroazomycin Arabinoside Procedure: Positron Emission Tomography

Detailed Description:

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.

OUTLINE:

Prior to CAR T-cell therapy, patients receive 18F-FAZA intravenously (IV). Beginning 2 hours after injection, patients undergo PET scan over 30-45 minutes.

After completion of study, patients are followed up for up to 6 months after CAR T-cell therapy.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-Cell Therapy
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : October 31, 2022


Group/Cohort Intervention/treatment
Diagnostic (18F-FAZA PET scan)
Prior to CAR T-cell therapy, patients receive 18F-FAZA IV. Beginning 2 hours after injection, patients undergo PET scan over 30-45 minutes.
Radiation: Fluorine F 18-fluoroazomycin Arabinoside
Given IV
Other Names:
  • 18F-FAZA
  • 18F-Fluoroazomycin Arabinoside
  • FAZA F-18
  • Fluoroazomycin Arabinoside F-18

Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Proportion of fluorine F 18-fluoroazomycin arabinoside (18F-FAZA) positron emission tomography (PET) scans with positive hypoxic volume (HV) [ Time Frame: After completion of one-time 18FFAZA PET scan, 1 day ]
    Will calculate the uniformly minimum-variance unbiased estimator, p-value and 95% confidence interval (CI) for the response rates.


Secondary Outcome Measures :
  1. Overall response (OR) [ Time Frame: At 30, 90, and 180 days after chimeric antigen receptor (CAR) T-cell therapy, up to 6 months ]
    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.


Other Outcome Measures:
  1. Serum ferritin measurements [ Time Frame: Up to 6 months after 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.

  2. C-reactive protein (CRP) measurements [ Time Frame: Up to 6 months after 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.

  3. Fibrinogen measurements [ Time Frame: Up to 6 months after 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.

  4. Hepatic aminotransferase measurements [ Time Frame: Up to 6 months after 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.

  5. Incidence of cytokine release syndrome (CRS), neurotoxicity, or other adverse events (AEs) attributed to CAR T-cell therapy [ Time Frame: Up to 6 months after 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.

  6. Standardized uptake value maximum (SUVmax) calculations for tumor sites based on 18F-FAZA versus fludeoxyglucose F-18 (18F-FDG) uptake [ Time Frame: Up to 6 months after 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsed or refractory malignancies who are planning to receive CAR T-cell therapy at University of California, San Francisco (UCSF)
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of:

    • Aggressive lymphoma, including: Diffuse large B-cell lymphoma (DLBCL) (including transformed disease), high-grade B-cell lymphoma, or primary mediastinal B-cell lymphoma
    • Multiple myeloma (MM), with imaging within 6 months of enrollment demonstrating >= 1 plasmacytoma measuring >= 5 cm along any axis
    • Other malignancy with radiographically measurable disease
  • 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
  • Planned 18F-FDG PET scan before receipt of CAR T-cell therapy
  • Ability to provide informed consent prior to study entry

Exclusion Criteria:

  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures
  • Body weight over 300 pounds (precluding use of PET scanner)
  • Pregnancy or active lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409314


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: C. Babis Andreadis, MD UCSF Medical Center-Mount Zion
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04409314    
Other Study ID Numbers: 20921
NCI-2020-03216 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Hypoxia
Recurrence
Aggression
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Behavioral Symptoms
Disease Attributes
Pathologic Processes
Fluoroazomycin arabinoside
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action