Table of Contents
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).[1]
The study was designed as an interventional trial, which means the research team gave the treatment and then measured the results.[1]
Who participated
The target group was elderly patients aged 70 years or older with relapsed or refractory AML.[1]
Relapsed means the cancer came back after treatment, and refractory means it did not respond well to treatment.[1]
What was studied
The trial tested Mebendazole together with low-dose Ara-C, using oral VERMOX forte or VERMOX and subcutaneous cytarabine.[1]
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.[1]
Study phases and endpoints
The study included a Phase I part and a Phase II part.[1]
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.[1]
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.[1]
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.[1]
Trial status and size
The study is marked as Completed and enrolled 50 participants.[1]
This means the planned study activities were finished and the trial is no longer recruiting new patients.[1]
