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Imaging Apoptosis for Lymphoma Treatment Response | Clinical Trials | Clareo Health

TERMINATEDEARLY_PHASE1

Imaging Apoptosis for Lymphoma Treatment Response

NCT05048732•Washington University School of Medicine

Summary

Apoptosis is a specific form of cell death that leads to clearance of dead cells without causing inflammation or injury to normal adjacent tissues. Targeted cancer therapeutics that target this pathway for tumor cell death induction are in development, but few specific biomarkers of apoptosis are available to assess treatment response. Apoptosis also occurs in response to standard anthracycline or combination therapies such as rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP), rituximab, etoposide, phosphate, prednisone, vincristine sulfacte, cyclophosphamide, and doxorubicin hydrocholoride (R-EPOCH) used to treat many different histopathological types of lymphoma including Hodgkin and non- Hodgkin lymphoma such as diffuse large B-cell lymphoma (DLBCL), Burkitts lymphoma, primary mediastinal B-cell lymphoma and double hit DLBCL. Caspase-3 activation occurs as a result of apoptosis and may be a specific marker of apoptosis. Therefore, this study will assess whether 18F-FluorApoTrace (18F-FAT), a caspase-3 targeted tracer, has a reasonable dosimetry profile and can be used to detect apoptosis in patients with lymphoma being treated with standard therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Adult 18 years of age or older
•No known hematological disorders
•Considered healthy based on assessment by Principal Investigator (PI).
•Able to provide informed consent
•Able to comprehend and willing to follow instructions for study procedures as called for by the protocol.
•Capable of lying still and supine within the PET/CT scanner for up to 1 hour at a time.
•Men or women 18 years of age or older with a new diagnosis of lymphoma who will be treated with standard of care therapy for curative intent and at least one measurable (RECIST 1.1), FDG-avid lesion. OR recurrent DLBLC with at least one measurable (RECIST 1.1) FDA-avid lesion and a minimum of 12 months since last receiving treatment.
•If applicable at least one FDG avid lesion accessible for biopsy (ultrasound guided preferred)
•Able to provide informed consent
•Able to tolerate standard of care systemic therapy as recommended by referring physician(s).

Exclusion Criteria

•No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents or illicit drugs) within the past year per self-reporting mechanisms.
•No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions.
•Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, OR of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 18 F-FAT) is negative
•Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, OR of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 18 F-FAT) is negative
•Not currently enrolled in another study using an investigational drug

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

December 6, 2021

Primary Completion Date

February 10, 2024

Completion Date

February 10, 2024

Last Updated

May 30, 2024

Enrollment

ACTUAL participants

Conditions

Diffuse Large B Cell Lymphoma

Interventions

18F-FluorApoTrace

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Imaging Apoptosis for Lymphoma Treatment Response

Inclusion Criteria

Exclusion Criteria

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

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Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers

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