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New treatment option for Central Nervous System Lymphoma
Official title Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR)
ClinicalTrials.gov ID: NCT06607549
What this study is testing
What is Loncastuximab tesirine and rituximab (Lonca-R)?
Loncastuximab tesirine and rituximab (Lonca-R) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for central nervous system lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant aged ≥ 18 years
- ECOG Performance Status ≤ 3
- Histologically confirmed primary CNS lymphoma or secondary diffuse large B-cell lymphoma (DLBCL) with CNS involvement with either:
- 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...
You likely can't join if
- 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...
- Known bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.
- Known Human immunodeficiency virus (HIV) infection.
See the full eligibility criteria
Who can join
- Participant aged ≥ 18 years
- ECOG Performance Status ≤ 3
- Histologically confirmed primary CNS lymphoma or secondary diffuse large B-cell lymphoma (DLBCL) with CNS involvement with either:
- 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...
- Note: For patients with a history of histologically documented systemic DLBCL with CNS relapse, a biopsy of the CNS lesion is recommended but not required.
- Must be a candidate for SRS. Lesion size must be \< 6 cm and the number of lesions must be \< 10.
- Must have evaluable disease. This includes radiographic evidence of parenchymal disease or parenchymal disease and disease detected in the CSF.
- Patients with vitreous or retinal involvement alone are not eligible.
- Patients with leptomeningeal disease or spinal cord disease are not eligible.
- Adequate organ function as defined as:
- Hematologic:
- Absolute neutrophil count ≥ 1000 cells/mm3 (1.00 x 109/L) independent of G-CSF support (i.e. no G-CSF within the past 3 days) unless there is documented bone marrow involvement.
- Platelet count ≥ 75,000 cells/mm3 (75 x 109/L) independent of transfusion support (i.e. no transfusion within the past 3 days) unless there is documented bone marrow involvement.
- Hemoglobin ≥ 8 g/dL (≥ 80 g/L) independent of transfusion support (i.e. no transfusion within the past 3 days) unless there is documented bone marrow involvement.
- Hepatic: ---Total bilirubin ≤ 2.0 mg/dL (unless bilirubin rise is due to Gilbert's syndrome), if total bilirubin is \> 2.0 mg/dL, the subject is eligible for the study if the direct bilirubin is normal; transaminases...
- Renal:
- Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:
- Males: ((140-age)×weight[kg])/(serum creatinine [mg/dL]×72)
- Females: (((140-age)×weight[kg])/(serum creatinine [mg/dL]×72))×0.85
- For people of childbearing potential: Negative pregnancy test or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative...
- \< 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
- ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses \>1 year ago; or
- Had chemotherapy-induced menopause with last menses \>1 year ago
- Female participants of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1 until 10 months after last dose of loncastuximab tesirine and 12 months after the...
- Provide written informed consent and comply with the study protocol as judged by the Investigator. Of note, if the subject has an impairment that prevents him/her from providing consent, the site may follow approved...
What rules you out
- 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...
- Known bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.
- Known Human immunodeficiency virus (HIV) infection.
- Prior allogeneic stem cell transplant (autologous stem cell transplant is NOT an exclusion).
- Prior exposure to loncastuximab tesirine
- Chemotherapy or targeted small molecule therapy (or other therapy for CNS lymphoma) within 3 weeks prior to the first day of study treatment (or 5 half-lives (whichever is shorter), or 2 weeks prior to the first day of...
- The patient must have recovered to baseline or ≤ grade 1 from prior toxicities of therapy with the exception of alopecia and myelosuppression provided lab criteria met. Recovery to ≤ grade 2 neuropathy is permitted.
- Cellular therapy within 8 weeks.
- Presence of clinically significant pericardial or pleural effusions, or third space fluid accumulations (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with...
- Congenital long QT syndrome or a corrected QT measure (QTc) interval of \>480 ms at screening (unless secondary to pacemaker or bundle branch block).
- Known history of hypersensitivity to CD19 antibody and/or, components of study medication.
- All people must be screened for hepatitis B and C. Patients with evidence of active hepatitis B infection, based on positive surface antigen or Hepatitis B DNA PCR are excluded. Patients who are Hepatitis B core...
- Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at time of screening.
- people with chronic liver disease with hepatic impairment Child-Pugh class C
- Pregnant or lactating or intending to become pregnant during the study.
- Patients diagnosed with another malignancy within three years or with any evidence of residual prior malignant disease (except nonmelanoma skin cancer, non-metastatic prostate cancer, in situ cervical cancer, or ductal...
- Unable to tolerate corticosteroids
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States; Providence, Rhode Island, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.