Clinical trial NCT04409314: Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-cell Therapy
Official title: Pilot Study of Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-Cell Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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 (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.

Eligibility 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
* 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
* Pregnancy or active lactation

Primary outcomes:
measure: Proportion of fluorine F 18-fluoroazomycin arabinoside (18F-FAZA) positron emission tomography (PET) scans with positive hypoxic volume (HV)
timeFrame: After completion of one-time 18F-FAZA PET scan, 1 day
Secondary outcomes:
measure: Overall response (OR)
timeFrame: At 30, 90, and 180 days after chimeric antigen receptor (CAR) T-cell therapy, up to 6 months
Other outcomes:
measure: Change in Mean Serum Ferritin levels
timeFrame: Up to 6 months after CAR T-cell therapy
measure: Change in Mean C-reactive protein (CRP) levels
timeFrame: Up to 6 months after CAR T-cell therapy
measure: Change in Mean Fibrinogen Levels
timeFrame: Up to 6 months after CAR T-cell therapy
measure: Change in Hepatic aminotransferase Levels
timeFrame: Up to 6 months after CAR T-cell therapy
measure: Incidence of cytokine release syndrome (CRS), neurotoxicity, or other adverse events (AEs) attributed to CAR T-cell therapy
timeFrame: Up to 6 months after CAR T-cell therapy
measure: Standardized uptake value maximum (SUVmax) calculations for tumor sites based on 18F-FAZA versus fludeoxyglucose F-18 (18F-FDG) uptake
timeFrame: Up to 6 months after CAR T-cell therapy
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: C. Babis Andreadis, MD
role: PRINCIPAL_INVESTIGATOR
References: