Table of contents
- Trial overview
- Who is being studied
- What the study measures
- Trial design and phase
- Patient-friendly terms
- Trial status and size
Trial overview
The clinical trial in the source data studies Allogeneic Umbilical Cord-Derived Cd34- Cells, Non-Expanded as part of cord blood transplantation in patients with serious blood diseases.[1] The study is designed to see whether this transplant approach is safe and whether it may help people stay free from relapse after treatment.[1]
Who is being studied
This trial focuses on people with high risk and very high risk acute leukemia/myelodysplasia who need an allogeneic haematopoietic stem cell transplantation.[1] In simple words, this means patients with aggressive blood cancer or bone marrow disease who need stem cells from a donor to replace damaged blood-making cells.[1]
The study is interventional, which means the research team gives the study treatment and then follows the results.[1] The trial title also describes it as an open-label study, meaning everyone involved knows what treatment is being used.[1]
What the study measures
The main outcome is relapse-free survival at 1 year and 2 years after transplant.[1] Relapse-free survival means the time after treatment during which the disease does not come back.[1]
The brief summary shows that the researchers also want to examine safety, including the rate of graft failure, and whether the transplant approach is feasible.[1] Graft failure means the transplanted cells do not take hold or do not work as expected.[1]
Trial design and phase
This study is a Phase 2 trial.[1] Phase 2 trials usually look for early signs that a treatment approach may help, while also continuing to track safety in a specific group of patients.[1]
The trial is authorised and plans to include 30 participants.[1] The intervention listed in the source is DOROCUBICEL, Allogeneic Umbilical Cord-Derived Cd34- Cells, Non-Expanded, given by intravenous infusion.[1]
Patient-friendly terms
Acute leukemia is a fast-growing cancer of the blood and bone marrow.[1] Myelodysplasia is a disorder where the bone marrow does not make healthy blood cells normally.[1]
Cord blood is blood collected from the umbilical cord after birth, and it can contain stem cells used in transplants.[1] A stem cell transplant is a treatment that replaces damaged blood-forming cells with healthy ones from a donor.[1]
Feasibility means whether the treatment plan can be carried out successfully in real patients.[1] These terms are important because the trial is not only asking if the transplant may work, but also if it can be done safely and in a practical way.[1]
Trial status and size
The trial status in the source is Authorised.[1] The planned enrollment is 30 people, so this is a small study designed to learn more about this transplant approach in a focused patient group.[1]
