Table of Contents
Trial overview
The source data includes one interventional study of Romidepsin given in combination with CHOEP as first-line treatment before hematopoietic stem cell transplantation.[1]
This study was completed and enrolled 125 participants.[1]
Who was studied
The trial focused on young patients with nodal peripheral T-cell lymphomas, which are cancers of a type of white blood cell called T-cells.[1]
The listed conditions were ALK negative anaplastic large T-cell lymphoma, angioimmunoblastic T-cell lymphoma, and peripheral T-cell lymphoma, NOS.[1]
Study design and phases
This was a Phase 1 study with a Phase 2 part described in the brief summary.[1]
Phase 1 was designed to define the maximum tolerated dose, which means the highest dose that can be given without causing too much harm.[1]
The study was also described as a phase I-II study, showing that it first checked safety and dose, then looked at treatment effect.[1]
Outcomes measured
The main Phase 1 outcome was dose-limiting toxicity, defined in the trial as grade 3 or higher non-haematological toxicity or a delay of more than 15 days in the planned cycle date during the first two cycles.[1]
Non-haematological toxicity means side effects not related to blood cells.[1]
The main Phase 2 outcome was progression-free survival at 18 months on an intention-to-treat basis.[1]
Progression-free survival means the time from enrollment until the disease gets worse, comes back, or the patient dies from any cause.[1]
What the trial asked
The study asked two main questions: what dose of Romidepsin with CHOEP could be used safely, and how effective this treatment could be for controlling the disease.[1]
In simple terms, the trial tried to find a safe treatment level first, then measure whether patients stayed free from progression for a meaningful period of time.[1]
