In short
Clinical trials are studying Vincristine in several cancer types, including lymphoma, leukemia, and medulloblastoma. These studies look at how Vincristine is used in treatment combinations and measure outcomes such as response, survival, and safety in different patient groups. The trials include children, adults, and older patients.
Key points
- Clinical trials with Vincristine are studying several cancers, especially lymphoma, leukemia, and medulloblastoma. The research includes children, adults, and older adults, depending on the trial. Most studies use Vincristine as part of a treatment combination rather than by itself. The trials are in early and late phases, including Phase 1/2, Phase 2, Phase 3, and Phase 4. Main outcomes include survival, response to treatment, safety, minimal residual disease, and in some studies, brain function or quality of life.
Trial overview
These studies investigate Vincristine as part of broader cancer treatment plans, not as a stand-alone treatment. The trials look at whether treatment combinations help patients live longer, avoid disease progression, or achieve a better response to therapy.
The trial data include both newly diagnosed disease and harder-to-treat settings such as relapsed or refractory cancer, which means cancer that has come back or did not respond well to earlier treatment.
Conditions being studied
Diffuse large B-cell lymphoma appears in several trials, including studies in newly diagnosed patients, non-GCB disease, and DLBCL-type Richter transformation.
Follicular lymphoma is studied in both newly diagnosed high-risk disease and advanced stage disease with high tumor burden, meaning a large amount of cancer in the body.
Medulloblastoma is studied in both newly diagnosed and low-risk groups, with some trials focused on children and adolescents and others on post-pubertal or adult patients.
Other studied conditions include acute B-cell lymphoblastic leukemia, Ph+ acute lymphoblastic leukemia, relapsed/refractory CD38 positive T-cell acute lymphoblastic leukemia, Burkitt lymphoma, and newly diagnosed grade 2 or 3 glioma.
Trial phases and study design
The trial set includes Phase 1/2, Phase 2, Phase 3, and Phase 4 studies.
The Phase 1/2 study in lymphoma is testing whether tazemetostat can be added safely to R-CHOP and help define the recommended phase II dose, which is the dose chosen for later testing.
Several Phase 3 trials compare one treatment plan with another, such as shortened versus standard chemotherapy, acalabrutinib plus R-CHOP versus placebo plus R-CHOP, or pirtobrutinib and epcoritamab versus R-(mini)-CHOP.
The Phase 4 medulloblastoma study focuses on event-free survival across different risk groups and treatment arms.
Who can participate
Eligibility depends on the disease and the treatment setting.
Some studies enroll adults only, such as the acute B-cell lymphoblastic leukemia study before stem cell transplantation and the trial in patients aged 80 years or older with diffuse large B-cell lymphoma.
Other studies focus on children and adolescents, especially in medulloblastoma trials, while some include post-pubertal and adult patients.
Several trials focus on newly diagnosed disease, while others include patients with relapsed, refractory, or minimal residual disease positive cancer, meaning small amounts of cancer remain after treatment.
Main endpoints measured
Common endpoints include progression-free survival, overall survival, and response rates such as complete response or overall response rate.
Some studies have special endpoints, such as minimal residual disease negativity in leukemia, complete metabolic remission on PET-CT scans in lymphoma, or qualified overall survival in glioma, which combines survival with brain function, thinking, and quality of life.
In medulloblastoma, one study measures full-scale IQ after 2.5 years, showing that some trials also track how treatment may affect learning and thinking.
The Phase 1/2 lymphoma study also measures treatment-emergent adverse events, which are side effects that appear after treatment starts, to help set the dose for later study.
Key trial details
- NCT02889523 studies newly diagnosed diffuse large B-cell lymphoma and high-risk follicular lymphoma, with the goal of finding the recommended phase II dose and measuring complete response rate and safety.
- NCT05058404 tests whether fewer chemotherapy cycles after an early response can still preserve progression-free survival in newly diagnosed advanced follicular lymphoma with high tumor burden.
- NCT04402073 compares personalized treatment with standard therapy in post-pubertal and adult patients with newly diagnosed medulloblastoma, using progression-free survival as the main outcome.
- 2023-509358-72-00 evaluates whether adding acalabrutinib to R-CHOP improves progression-free survival in previously untreated non-GCB diffuse large B-cell lymphoma.
- NCT03610438 studies adult patients with acute B-cell lymphoblastic leukemia who have minimal residual disease before stem cell transplantation, with the goal of reaching MRD negativity.
- NCT06220032 looks at whether dexrazoxane can prevent anthracycline-induced cardiac dysfunction in diffuse large B-cell lymphoma and compares complete metabolic remission rates after R-CHOP21.
- NCT05331521 compares treatment strategies for newly diagnosed grade 2 or 3 glioma and uses qualified overall survival as the main endpoint.
- NCT02066220 follows children and adolescents with medulloblastoma and measures event-free survival across several risk groups.
- 2024-517133-40-00 compares two standard regimens for low-risk medulloblastoma and measures full-scale IQ after treatment.
- 2023-503423-25-00 compares two treatment approaches in newly diagnosed high-risk Burkitt lymphoma and measures 2-year progression-free survival.
- NCT04974216 studies patients aged 80 years or older with diffuse large B-cell lymphoma and measures overall response rate after three cycles or at treatment stop.
- 2023-507899-47-00 studies relapsed or refractory CD38 positive T-cell acute lymphoblastic leukemia and measures complete hematologic response after two cycles of induction therapy.
- NCT04475731 evaluates ponatinib alone or with chemotherapy in Ph+ acute lymphoblastic leukemia and measures MRD negativity or reduction after three months.
- 2024-513445-37-00 compares pirtobrutinib plus epcoritamab with R-(mini)-CHOP in previously untreated DLBCL-type Richter transformation and measures investigator-assessed progression-free survival.
Patient-friendly terms
Newly diagnosed means the cancer has just been found. Relapsed means the cancer came back after treatment, and refractory means it did not respond well to treatment.
High tumor burden means there is a large amount of cancer in the body. Minimal residual disease means tiny amounts of cancer may still be present even when routine tests look better.
PET-CT is an imaging test that helps show whether cancer is still active. Neurocognitive refers to thinking skills such as memory, attention, and learning.