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.
Participant aged ≥ 18 years
ECOG Performance Status ≤ 3
Relapsed or refractory disease with at least 1 prior therapy OR
Ineligible for high-dose methotrexate-based therapy as determined by the treating physician, including previously untreated patients. Examples of medical conditions for which a patient could be considered ineligible for high-dose methotrexate include but not limited to renal impairment, liver disease, heart failure.
Concurrent use of other approved or investigational antineoplastic agents (with the exception of corticosteroids).
History of intracranial hemorrhage or clinically significant stroke within 6 months prior to enrollment
History of prior radiation to the CNS.
Significant medical diseases or conditions, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction in the past 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, severely immunocompromised state, and congestive heart failure, New York Heart Association Class III-IV.
Single group
Loncastuximab tesirine and rituximab (Lonca-R)
DrugPatients will receive stereotactic radiosurgery (SRS) followed by a brain MRI approx. 3 weeks after SRS. This will be followed by loncastuximab tesirine and rituximab administered intravenously for a total of 6 cycles (every 21 days).
A safe and tolerable dose of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy.
Maximum Tolerated Dose (MTD): MTD is defined as the highest dose under consideration that has an estimated DLT probability below 25% based upon the Bayesian optimal interval design. The MTD will be decided based on the BOIN decision rules set for phase 1a portion of the study.
To assess best overall response rate (ORR) following lonca-R
To evaluate the preliminary efficacy (ORR) of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy.
To assess best complete response (CR) rate following lonca-R.
To evaluate the preliminary efficacy (complete response rate) of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
To determine the safety and tolerability of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy.
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University of Utah
Lead sponsor
ADC Therapeutics S.A.
Collaborator
