Trial Title:
Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma
NCT ID:
NCT05800405
Condition:
Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (leukapheresis, external beam radiation, CAR-T)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Biological
Intervention name:
Chimeric Antigen Receptor T-Cell Therapy
Description:
Receive CAR-T per standard of care
Arm group label:
Treatment (leukapheresis, external beam radiation, CAR-T)
Other name:
CAR T Infusion
Other name:
CAR T Therapy
Other name:
CAR T-cell Therapy
Other name:
Chimeric Antigen Receptor T-cell Infusion
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT
Arm group label:
Treatment (leukapheresis, external beam radiation, CAR-T)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Radiation
Intervention name:
External Beam Radiation Therapy
Description:
Undergo radiation therapy
Arm group label:
Treatment (leukapheresis, external beam radiation, CAR-T)
Other name:
Definitive Radiation Therapy
Other name:
EBRT
Other name:
External Beam Radiation
Other name:
External Beam Radiotherapy
Other name:
External Beam RT
Other name:
external radiation
Other name:
External Radiation Therapy
Other name:
external-beam radiation
Other name:
Radiation, External Beam
Other name:
Teleradiotherapy
Other name:
Teletherapy
Other name:
Teletherapy Radiation
Intervention type:
Procedure
Intervention name:
Leukapheresis
Description:
Receive leukapheresis
Arm group label:
Treatment (leukapheresis, external beam radiation, CAR-T)
Other name:
Leukocytopheresis
Other name:
Therapeutic Leukopheresis
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (leukapheresis, external beam radiation, CAR-T)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Treatment (leukapheresis, external beam radiation, CAR-T)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Summary:
This early phase I clinical trial evaluates bridging radiation therapy given before
chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL)
that has come back (relapsed) or has not responded to previous treatment (refractory).
Patients with relapsed or refractory disease have historically poor prognosis. CAR T-cell
therapy is a type of treatment in which a patient's T-cells (a type of immune system
cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken
from a patient's blood (leukapheresis). Then the gene for a special receptor that binds
to a certain protein on the patient's cancer cells is added to the T-cells in the
laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large
numbers of the CAR T-cells are grown in the laboratory and given to the patient by
infusion for treatment of certain cancers. While the outcomes from CAR T-cell therapy
appear favorable, in the time between leukapheresis and CAR T-cell infusion many patients
have symptomatic or life-threatening disease which often requires bridging therapy.
Bridging therapy aims to slow disease progression and control symptoms during this
critical period prior to CAR T-cell infusion. Radiation therapy uses high energy x-rays,
particles, or radioactive seeds to kill cancer cells. Giving bridging radiation therapy
to patients with relapsed or refractory LBCL prior to CAR T-cell infusion may improve
treatment outcomes with minimal toxicity.
Detailed description:
PRIMARY OBJECTIVE:
I. Evaluate if bridging radiation to all sites of F-fluorodeoxyglucose (FDG)-avid disease
can be feasibly administered prior to commercial CAR T-cell infusion in patients with
large B-cell lymphoma (LBCL).
SECONDARY OBJECTIVES:
I. Assess the toxicities of bridging radiation in patients with LBCL. II. Assess overall
response rate, complete response rate, progression-free survival, local control, distant
control, and overall survival after bridging radiation and CAR T-cell infusion in
patients with LBCL.
EXPLORATORY OBJECTIVES:
I. Bank blood for future immune profiling or other correlatives. II. Explore the
association between positron emission tomography (PET)/computed tomography (CT) radiomic
features and clinical outcomes.
III. Collect PET/CT imaging data using the RefleXion X1 linear accelerator imaging
system.
OUTLINE:
Patients undergo leukapheresis per standard of care, undergo external beam radiation
therapy, and undergo CAR T-cell infusion per standard of care on study. Patients undergo
PET/CT throughout the study and may undergo magnetic resonance imaging (MRI) during
screening. Patients also undergo blood sample collection throughout the study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Documented informed consent of the participant and/or legally authorized
representative.
- Assent, when appropriate, will be obtained per institutional guidelines.
- Age: >= 18 years.
- Eastern Cooperative Oncology Group (ECOG) =< 2 or Karnofsky Performance Status (KPS)
>= 60.
- Histologically confirmed large B-cell lymphoma.
- Relapsed/refractory disease.
- Planned to undergo commercial CAR T-cell infusion within 3 months of enrollment.
- 6 or fewer sites (treatable with a maximum of 3 isocenters) of FDG-PET avid disease,
treatable with a a maximum of 3 isocenters.
- Measurable disease e.g., at least 1.5 cm on CT/MRI or by Response Evaluation
Criteria in Solid Tumors 1.1 (RECIST 1.1).
- Fully recovered from the acute toxic effects (except alopecia) to =< grade 1 to
prior anti-cancer therapy.
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
(performed within 30 days prior to day 1 of protocol therapy).
- If the urine test is positive or cannot be confirmed as negative, a serum
pregnancy test will be required.
Exclusion Criteria:
- Prior CD19-directed therapy.
- Radiation therapy within 21 days prior to day 1 of protocol therapy.
- Central nervous system (CNS) disease.
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to study agent.
- Active diarrhea.
- Clinically significant uncontrolled illness.
- Active infection requiring antibiotics.
- Other active malignancy.
- Females only: Pregnant.
- Any other condition that would, in the investigator's judgment, contraindicate the
patient's participation in the clinical study due to safety concerns with clinical
study procedures.
- Prospective participants who, in the opinion of the investigator, may not be able to
comply with all study procedures (including compliance issues related to
feasibility/logistics).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Savita V. Dandapani
Phone:
626-218-5334
Phone ext:
82071
Email:
sdandapani@coh.org
Investigator:
Last name:
Savita V. Dandapani
Email:
Principal Investigator
Start date:
July 20, 2023
Completion date:
October 20, 2025
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05800405
