In short
Clinical trials are studying Vinblastine Sulfate in several cancers and pediatric conditions. These studies look at safety, treatment response, and survival in children, teens, and adults. Many trials compare Vinblastine Sulfate with other treatments or use it as part of a larger treatment plan.
Key points
- Clinical trials of Vinblastine Sulfate study several cancers, especially lymphoma and pediatric brain tumors. The studies include children, teenagers, young adults, and some adults, depending on the disease. Trial phases range from Phase 1 to Phase 4, showing that Vinblastine Sulfate is being tested in early safety studies as well as larger studies of treatment benefit. The main outcomes include survival, tumor response, disease control, and treatment toxicity. Some trials use Vinblastine Sulfate alone, while others use it in combinations or compare it with other treatments. Several studies are already authorised, and some are completed.
Trial overview
These clinical trials study Vinblastine Sulfate in different cancer settings, often as part of a larger treatment plan. 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.
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. The studies are in different phases, from early testing to larger confirmatory trials.
Main conditions being studied
The trials cover a wide range of cancers and related diseases. The most common areas are Hodgkin lymphoma, anaplastic large cell lymphoma, pediatric low-grade glioma, medulloblastoma, and Langerhans cell histiocytosis.
- Hodgkin lymphoma: Several trials study Vinblastine Sulfate in children, young adults, and adults with classical or advanced stage Hodgkin lymphoma.
- Anaplastic large cell lymphoma: One international Phase 3 study looks at standard risk ALK-positive disease in children and adolescents.
- Pediatric low-grade glioma: Trials study children with low-grade glioma and related brain tumors, including progressive or relapsed disease.
- Medulloblastoma: A large Phase 4 trial studies children and adolescents with this brain tumor and measures event-free survival.
- Langerhans cell histiocytosis: A large collaborative pediatric protocol includes Vinblastine Sulfate among several treatment options.
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.
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. The phases range from Phase 1 to Phase 4.
- 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.
- Phase 2 trials often look at early signs of benefit, such as response rate, disease control, or progression-free survival.
- Phase 3 trials compare treatment strategies in larger groups and often test whether one approach is better than another.
- Phase 4 trials study treatment in broader real-world use or in large collaborative protocols.
Some studies are randomized, which means people are assigned by chance to different treatment groups. Others are single-arm studies, where everyone receives the same treatment plan and results are measured against the study goals.
Main endpoints and what they mean
The main endpoints, or main results, vary by disease and trial design. Many studies measure survival or response to treatment, while others focus on safety or disease control.
- 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.
- Progression-free survival (PFS) is used in brain tumor and breast cancer studies. It measures how long the disease stays from getting worse.
- Objective response rate (ORR) measures how many patients have a complete or partial response to treatment.
- Pathological complete response means no visible cancer is found in the removed tissue and lymph nodes after treatment, based on the study rules.
- Minimal residual disease (MRD) and undetectable MRD are used in blood cancer studies to see whether any disease remains after treatment.
- Dose-limiting toxicity is used in early studies to check whether the treatment can be given safely.
Some trials also measure overall survival, which is the time from the study start point until death from any cause. Others look at treatment burden, immune reconstitution, or the rate of permanent consequences after therapy.
Who can participate
Eligibility depends on the disease, age, and treatment history in each trial. The source data show that some studies are for children and adolescents, some for young adults, and some for adults only.
- Children and adolescents are included in studies of anaplastic large cell lymphoma, medulloblastoma, Langerhans cell histiocytosis, pediatric low-grade glioma, and pediatric solid tumors.
- Young adults are included in some Hodgkin lymphoma studies.
- Adults are included in the metastatic soft tissue sarcoma study and some rare B-cell malignancy studies.
Some trials require newly diagnosed disease, while others focus on relapsed, refractory, or progressive disease. Relapsed means the disease came back after treatment, refractory means it did not respond well to treatment, and progressive means it is getting worse.
Key trials in this set
Several trials stand out because they are large, use Vinblastine Sulfate directly, or focus on important patient groups.
- NCT02231385: A Phase 3 study in children and young adults with classical Hodgkin lymphoma that measures objective response rate in slow early responders.
- NCT04685616: A Phase 3 study in previously untreated stage IA/IIA Hodgkin lymphoma that compares treatment strategies using progression-free survival.
- NCT01712490: A completed Phase 3 frontline study in advanced classical Hodgkin lymphoma that compared modified progression-free survival between treatment arms.
- 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.
- NCT02066220: A Phase 4 medulloblastoma study with event-free survival as the main outcome.
- NCT02205762: A large Phase 4 pediatric protocol for Langerhans cell histiocytosis that studies reactivation-free survival, overall survival, and late effects.
- 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.
- 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.
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. The studies ask practical questions such as whether treatment helps patients live longer, stay free of disease events, or respond better to therapy.
Not every trial uses Vinblastine Sulfate in the same way. 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.
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.