Table of Contents
- Trial overview
- Conditions being studied
- Trial phases and study design
- Who can participate
- Main endpoints measured
- Key trial details
- Patient-friendly terms
Trial overview
These studies investigate Vincristine as part of broader cancer treatment plans, not as a stand-alone treatment.[1] The trials look at whether treatment combinations help patients live longer, avoid disease progression, or achieve a better response to therapy.[1]
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.[1][2]
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.[1][4][6][12]
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.[1][2]
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.[3][7][8]
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.[5][9][10][11]
Trial phases and study design
The trial set includes Phase 1/2, Phase 2, Phase 3, and Phase 4 studies.[1][2][3][4][5][6][7][8][9][10][11][12]
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.[1]
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.[2][4][12]
The Phase 4 medulloblastoma study focuses on event-free survival across different risk groups and treatment arms.[7]
Who can participate
Eligibility depends on the disease and the treatment setting.[1][2][3][4][5][6][7][8][9][10][11][12]
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.[5][9]
Other studies focus on children and adolescents, especially in medulloblastoma trials, while some include post-pubertal and adult patients.[3][7][8]
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.[1][5][10]
Main endpoints measured
Common endpoints include progression-free survival, overall survival, and response rates such as complete response or overall response rate.[1][2][4][6][8][9][12]
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.[5][6][11]
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.[8]
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.[1]
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.[1]
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.[2]
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.[3]
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.[4]
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.[5]
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.[6]
NCT05331521 compares treatment strategies for newly diagnosed grade 2 or 3 glioma and uses qualified overall survival as the main endpoint.[11]
NCT02066220 follows children and adolescents with medulloblastoma and measures event-free survival across several risk groups.[7]
2024-517133-40-00 compares two standard regimens for low-risk medulloblastoma and measures full-scale IQ after treatment.[8]
2023-503423-25-00 compares two treatment approaches in newly diagnosed high-risk Burkitt lymphoma and measures 2-year progression-free survival.[9]
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.[10]
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.[11]
NCT04475731 evaluates ponatinib alone or with chemotherapy in Ph+ acute lymphoblastic leukemia and measures MRD negativity or reduction after three months.[10]
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.[12]
Patient-friendly terms
Newly diagnosed means the cancer has just been found.[1] Relapsed means the cancer came back after treatment, and refractory means it did not respond well to treatment.[5][10]
High tumor burden means there is a large amount of cancer in the body.[2] Minimal residual disease means tiny amounts of cancer may still be present even when routine tests look better.[5][10]
PET-CT is an imaging test that helps show whether cancer is still active.[6] Neurocognitive refers to thinking skills such as memory, attention, and learning.[8]
