In short
Mebendazole is being studied in clinical trials as part of treatment combinations for specific cancers. These trials mainly look at safety, effective dose, and early signs of benefit in elderly patients with relapsed or refractory acute myeloid leukemia (AML).
Key points
- Mebendazole is being studied in a clinical trial for elderly patients with relapsed or refractory acute myeloid leukemia. The study tests Mebendazole together with low-dose Ara-C, also called cytarabine. It includes a Phase I part to find a safe dose and check side effects, and a Phase II part to see how many patients reach remission within three months. The trial is interventional, meaning the researchers give the treatment and measure the results. The study has been completed and included 50 participants. The main focus is safety, dose finding, and early signs of benefit in this specific patient group.
Trial overview
This clinical trial studied Mebendazole in combination with low-dose Ara-C, also called cytarabine, for elderly patients with relapsed or refractory acute myeloid leukemia (AML).
The study was designed as an interventional trial, which means the research team gave the treatment and then measured the results.
Who participated
The target group was elderly patients aged 70 years or older with relapsed or refractory AML.
Relapsed means the cancer came back after treatment, and refractory means it did not respond well to treatment.
What was studied
The trial tested Mebendazole together with low-dose Ara-C, using oral VERMOX forte or VERMOX and subcutaneous cytarabine.
The main goal in the early part of the study was to see whether this combination was safe and whether a useful dose of Mebendazole could be found for further testing.
Study phases and endpoints
The study included a Phase I part and a Phase II part.
In Phase I, the researchers measured the frequency and severity of adverse events, which are unwanted medical problems during treatment, to determine the maximum tolerated dose and a biologically relevant Phase II regimen.
In Phase II, the main endpoint was the combined rate of complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) within three months.
CR means no signs of leukemia are found after treatment, while CRi means the bone marrow looks clear but blood counts have not fully recovered.
Trial status and size
The study is marked as Completed and enrolled 50 participants.
This means the planned study activities were finished and the trial is no longer recruiting new patients.