Table of contents
- Trial overview
- Main conditions being studied
- Trial phases and study designs
- Main endpoints and what they mean
- Who can participate
- Key trials in this set
- Patient-focused takeaways
Trial overview
These clinical trials study Vinblastine Sulfate in different cancer settings, often as part of a larger treatment plan.[1] The trials include both pediatric and adult patients, and they focus on how well treatment works, how long disease stays controlled, and how safe the treatment approach is.[1]
Some studies compare Vinblastine Sulfate with other treatments, while others use it in combination with several medicines or as monotherapy, which means treatment with one drug only.[2] The studies are in different phases, from early testing to larger confirmatory trials.[1]
Main conditions being studied
The trials cover a wide range of cancers and related diseases.[1] The most common areas are Hodgkin lymphoma, anaplastic large cell lymphoma, pediatric low-grade glioma, medulloblastoma, and Langerhans cell histiocytosis.[1]
Hodgkin lymphoma: Several trials study Vinblastine Sulfate in children, young adults, and adults with classical or advanced stage Hodgkin lymphoma.[1]
Anaplastic large cell lymphoma: One international Phase 3 study looks at standard risk ALK-positive disease in children and adolescents.[1]
Pediatric low-grade glioma: Trials study children with low-grade glioma and related brain tumors, including progressive or relapsed disease.[1]
Medulloblastoma: A large Phase 4 trial studies children and adolescents with this brain tumor and measures event-free survival.[1]
Langerhans cell histiocytosis: A large collaborative pediatric protocol includes Vinblastine Sulfate among several treatment options.[1]
Other studies include early triple-negative breast cancer, progressive or refractory pediatric solid tumors, mature aggressive B-cell lymphoma and leukemia, and rare B-cell malignancies such as Richter transformation and Burkitt lymphoma.[1]
Trial phases and study designs
The Vinblastine Sulfate trials in this set are mostly interventional, meaning the researchers assign a treatment and then measure what happens.[1] The phases range from Phase 1 to Phase 4.[1]
Phase 1 trials focus on early testing. In the pediatric solid tumor study, the first stage checks dose-limiting toxicity, which means side effects serious enough to limit treatment.[1]
Phase 2 trials often look at early signs of benefit, such as response rate, disease control, or progression-free survival.[1]
Phase 3 trials compare treatment strategies in larger groups and often test whether one approach is better than another.[1]
Phase 4 trials study treatment in broader real-world use or in large collaborative protocols.[1]
Some studies are randomized, which means people are assigned by chance to different treatment groups.[1] Others are single-arm studies, where everyone receives the same treatment plan and results are measured against the study goals.[1]
Main endpoints and what they mean
The main endpoints, or main results, vary by disease and trial design.[1] Many studies measure survival or response to treatment, while others focus on safety or disease control.[1]
Event-free survival (EFS) is used in lymphoma and medulloblastoma studies. It measures the time until a defined event such as progression, relapse, non-response, secondary cancer, or death.[1]
Progression-free survival (PFS) is used in brain tumor and breast cancer studies. It measures how long the disease stays from getting worse.[1]
Objective response rate (ORR) measures how many patients have a complete or partial response to treatment.[1]
Pathological complete response means no visible cancer is found in the removed tissue and lymph nodes after treatment, based on the study rules.[1]
Minimal residual disease (MRD) and undetectable MRD are used in blood cancer studies to see whether any disease remains after treatment.[1]
Dose-limiting toxicity is used in early studies to check whether the treatment can be given safely.[1]
Some trials also measure overall survival, which is the time from the study start point until death from any cause.[1] Others look at treatment burden, immune reconstitution, or the rate of permanent consequences after therapy.[1]
Who can participate
Eligibility depends on the disease, age, and treatment history in each trial.[1] The source data show that some studies are for children and adolescents, some for young adults, and some for adults only.[1]
Children and adolescents are included in studies of anaplastic large cell lymphoma, medulloblastoma, Langerhans cell histiocytosis, pediatric low-grade glioma, and pediatric solid tumors.[1]
Young adults are included in some Hodgkin lymphoma studies.[1]
Adults are included in the metastatic soft tissue sarcoma study and some rare B-cell malignancy studies.[1]
Some trials require newly diagnosed disease, while others focus on relapsed, refractory, or progressive disease.[1] Relapsed means the disease came back after treatment, refractory means it did not respond well to treatment, and progressive means it is getting worse.[1]
Key trials in this set
Several trials stand out because they are large, use Vinblastine Sulfate directly, or focus on important patient groups.[1]
NCT02231385: A Phase 3 study in children and young adults with classical Hodgkin lymphoma that measures objective response rate in slow early responders.[1]
NCT04685616: A Phase 3 study in previously untreated stage IA/IIA Hodgkin lymphoma that compares treatment strategies using progression-free survival.[1]
NCT01712490: A completed Phase 3 frontline study in advanced classical Hodgkin lymphoma that compared modified progression-free survival between treatment arms.[1]
2022-501454-11-00: An international Phase 3 study in standard risk ALK-positive anaplastic large cell lymphoma that aims to estimate 3-year event-free survival with Vinblastine monotherapy.[1]
NCT02066220: A Phase 4 medulloblastoma study with event-free survival as the main outcome.[1]
NCT02205762: A large Phase 4 pediatric protocol for Langerhans cell histiocytosis that studies reactivation-free survival, overall survival, and late effects.[1]
NCT05566795: A Phase 3 pediatric low-grade glioma study comparing tovorafenib with standard chemotherapy, where Vinblastine-containing standard care is part of the comparator group.[1]
2024-516896-34-00: A Phase 1 umbrella study in progressive, relapsed, or refractory pediatric low-grade glioma that checks safety and best response for combination regimens including Vinblastine Sulfate.[1]
Patient-focused takeaways
From the trial data, Vinblastine Sulfate is being studied mainly in cancer care, especially in children and adolescents, but also in some adults.[1] The studies ask practical questions such as whether treatment helps patients live longer, stay free of disease events, or respond better to therapy.[1]
Not every trial uses Vinblastine Sulfate in the same way.[1] In some studies it is the main treatment, while in others it is one part of a larger drug combination or a comparison arm against another standard treatment.[1]
The trial goals are different, but they all aim to answer whether the treatment plan is safe, effective, or better than another option for a specific group of patients.[1]
