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

NCT04409314 | Completed DMC FDA Drug

• 2 other identifiers: 20921NCI-2020-03216
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Overall response (OR)

  At 30, 90, and 180 days after chimeric antigen receptor (CAR) T-cell therapy, up to 6 months

Other Outcomes (6)

• Change in Mean Serum Ferritin levels

  Up to 6 months after CAR T-cell therapy

• Change in Mean C-reactive protein (CRP) levels

  Up to 6 months after CAR T-cell therapy

• Change in Mean Fibrinogen Levels

  Up to 6 months after CAR T-cell therapy

Study Arms (1)

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.

Drug: Fluorine F 18-fluoroazomycin Arabinoside; Procedure: Positron Emission Tomography

Interventions

Fluorine F 18-fluoroazomycin Arabinoside DRUG

Given IV

Also known as: 18F-FAZA, 18F-Fluoroazomycin Arabinoside, FAZA F-18, Fluoroazomycin Arabinoside F-18

Diagnostic (18F-FAZA PET scan)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (18F-FAZA PET scan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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
• Ability to provide informed consent prior to study entry

You may not qualify if:

• 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
• Pregnancy or active lactation

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 37300573 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence; Multiple Myeloma; Neoplasms

Interventions

fluoroazomycin arabinoside; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• C. Babis Andreadis, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 1, 2020
• Study Start: April 16, 2020
• Primary Completion: August 9, 2023
• Study Completion: August 9, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)