Actively Recruiting
Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR)
Led by University of Utah · Updated on 2025-12-03
12
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
A
ADC Therapeutics S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to learn if drugs loncastuximab tesirine and rituximab (lonca-R) after stereotactic radiosurgery are safe and effective for treatment of central nervous system lymphomas.
CONDITIONS
Official Title
Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant aged 63 18 years
- ECOG Performance Status 64 3
- Histologically confirmed primary CNS lymphoma or secondary diffuse large B-cell lymphoma (DLBCL) with CNS involvement
- Relapsed or refractory disease with at least 1 prior therapy OR ineligible for high-dose methotrexate-based therapy
- Candidate for stereotactic radiosurgery with lesion size < 6 cm and fewer than 10 lesions
- Evaluable disease by radiographic evidence of parenchymal disease or presence in CSF
- Adequate organ function including hematologic, hepatic, and renal parameters as defined
- Negative pregnancy test or permanent surgical sterilization for those of childbearing potential
- Female participants of childbearing potential must agree to use effective contraception until 10 months after loncastuximab tesirine and 12 months after rituximab
- Male participants with female partners of childbearing potential must use effective contraception until 7 months after last dose of loncastuximab tesirine
- Written informed consent and compliance with study protocol
You will not qualify if you...
- Concurrent use of other approved or investigational antineoplastic agents (except corticosteroids)
- History of intracranial hemorrhage or significant stroke within 6 months prior to enrollment
- Prior radiation to the CNS
- Significant medical diseases increasing risk including recent myocardial infarction, unstable angina, uncontrolled diabetes, active infections, immunocompromised state, congestive heart failure NYHA Class III-IV
- Known bleeding disorders or active bleeding
- Known HIV infection
- Prior allogeneic stem cell transplant
- Prior exposure to loncastuximab tesirine
- Recent chemotherapy, targeted therapy, or CNS lymphoma therapy within defined washout periods
- Unresolved toxicities from prior therapies except alopecia and myelosuppression; neuropathy recovery to grade 64 2 permitted
- Cellular therapy within 8 weeks
- Clinically significant pericardial or pleural effusions or third space fluid accumulations
- Congenital long QT syndrome or QTc >480 ms unless due to pacemaker or bundle branch block
- Known hypersensitivity to CD19 antibody or study medication components
- Active hepatitis B infection or uncontrolled hepatitis C
- Active systemic infection requiring treatment at screening
- Chronic liver disease with hepatic impairment Child-Pugh class C
- Pregnant, lactating, or intending to become pregnant during the study
- Diagnosis of another malignancy within 3 years or residual prior malignant disease except certain skin, prostate, cervical, or breast cancers unless approved by study PI
- Unable to tolerate corticosteroids
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rachel Kingsford
CONTACT
N
Narendranath Epperla, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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