In short
Clinical trials are studying Romidepsin in people with certain T-cell lymphomas. These studies look at safety, dose limits, and how well the treatment works, especially before stem cell transplantation. The target groups include young patients with nodal peripheral T-cell lymphomas.
Key points
- Clinical trials of Romidepsin in the source data focus on young patients with nodal peripheral T-cell lymphomas. The main study tested Romidepsin with CHOEP as first-line treatment before hematopoietic stem cell transplantation. It was designed as a Phase 1 and Phase 2 study, with Phase 1 looking at dose-limiting toxicity and Phase 2 looking at progression-free survival. The trial included 125 participants and was completed. The conditions studied included ALK negative anaplastic large T-cell lymphoma, angioimmunoblastic T-cell lymphoma, and peripheral T-cell lymphoma, NOS.
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.
This study was completed and enrolled 125 participants.
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.
The listed conditions were ALK negative anaplastic large T-cell lymphoma, angioimmunoblastic T-cell lymphoma, and peripheral T-cell lymphoma, NOS.
Study design and phases
This was a Phase 1 study with a Phase 2 part described in the brief summary.
Phase 1 was designed to define the maximum tolerated dose, which means the highest dose that can be given without causing too much harm.
The study was also described as a phase I-II study, showing that it first checked safety and dose, then looked at treatment effect.
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.
Non-haematological toxicity means side effects not related to blood cells.
The main Phase 2 outcome was progression-free survival at 18 months on an intention-to-treat basis.
Progression-free survival means the time from enrollment until the disease gets worse, comes back, or the patient dies from any cause.
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.
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.