In short
Clinical trials investigating Yttrium-90 are studying new treatment approaches in people with certain cancers, including lymphoma and neuroendocrine tumors. These studies look at safety, tolerability, dose, and how well the treatment works. The trials involve patients with non-Hodgkin lymphoma, CNS lymphoma, and gastrointestinal neuroendocrine tumors.
Key points
- Clinical trials investigating Yttrium-90 are focused on cancer, especially non-Hodgkin lymphoma, CNS lymphoma, and gastrointestinal neuroendocrine tumors. The studies include early Phase 1 trials that mainly test safety, tolerability, and dose, as well as a Phase 3 trial that looks at disease progression. The target groups include patients with advanced lymphoproliferative cancers, CXCR4-positive CNS lymphoma, and confirmed diffuse or locally unresectable neuroendocrine tumors. Some trials combine Yttrium-90 with other treatments, such as high-dose chemotherapy, stem cell transplant, or tandem isotope therapy. The main outcomes include maximum tolerated dose, overall response rate, side effects, and scan-based tumor control.
Trial overview
The source data includes three interventional studies of Yttrium-90, all of them authorised and designed for cancer care research. Two studies are in Phase 1, and one study is in Phase 3. The main cancer groups studied are non-Hodgkin lymphomas, central nervous system (CNS) lymphoma, and gastrointestinal neuroendocrine tumors.
Lymphoma studies
One Phase 1 study, called the COLPRIT Phase I/II study, is in people with advanced lymphoproliferative cancers, especially non-Hodgkin lymphomas (NHL). It studies [90Y]Y-PentixaTher together with high-dose chemotherapy and then autoSCT, which means autologous stem cell transplant using the patient’s own stem cells. The study aims to find the maximum tolerated dose in Phase I and then measure overall response rate in Phase II.
Another Phase 1 study looks at [90Y]Y-PentixaTher in patients with recurrent or refractory primary or isolated secondary CNS lymphoma. Recurrent means the cancer has come back, and refractory means it has not responded well to treatment. This study also includes [68Ga]Ga-PentixaFor imaging and LysaKare, and it is designed to assess safety, tolerability, body distribution, and efficacy, while also finding a recommended Phase 2 dose.
For this CNS lymphoma study, the listed primary outcomes include side effects, dose-limiting toxicity, changes in vital signs, laboratory values, physical exam findings, ECG findings, stem cell transplant after treatment, and mortality at 30 and 90 days after treatment. These outcomes show that the study is closely tracking both short-term safety and early treatment effects.
Neuroendocrine tumor study
The Phase 3 study investigates a tandem treatment approach for diagnosed and histopathologically confirmed diffuse or locally unresectable, well and intermediate differentiated neuroendocrine tumors of the gastrointestinal tract. Histopathologically confirmed means the diagnosis was checked under a microscope from tissue samples. The study uses DuoNEN solution for injection and aims to develop a treatment algorithm based on personalized dosimetry, which means planning treatment using patient-specific radiation measurements.
The primary outcome is disease progression measured by CT or MRI using RECIST 1.1, a standard system for checking whether tumors shrink, stay stable, or grow. Scans are planned after therapy at 3, 6, 12, 24, 36, 49, and 60 months, showing that this study follows patients for a long time.
Main outcomes and what they mean
Across the trials, the most important outcomes are safety, dose finding, and treatment effect. In the lymphoma studies, researchers measure maximum tolerated dose, overall response rate, side effects, and short-term mortality. In the neuroendocrine tumor study, the main focus is disease progression on imaging scans over time.
The studies also use imaging and laboratory checks to understand how the treatment is affecting the body. These checks include vital signs, blood and urine tests, physical examination, and ECG, which is a test that records the heart’s electrical activity.
Who can join these studies
Eligibility depends on the study and the cancer type. The lymphoma trials include people with non-Hodgkin lymphoma or CXCR4-positive CNS lymphoma, including recurrent or refractory cases. The Phase 3 study includes patients with diffuse or locally unresectable gastrointestinal neuroendocrine tumors that are well or intermediate differentiated.
These trials are not general studies for all patients with cancer. They are focused studies with specific disease types, imaging or biological targets, and clear outcome measures.