In short
Clinical trials are studying Allogeneic Umbilical Cord-Derived Cd34- Cells, Non-Expanded in people with high and very high-risk acute leukemia or myelodysplasia who need an allogeneic stem cell transplant. These trials aim to check safety, feasibility, graft failure, and relapse-free survival after transplant.
Key points
- Clinical trials of Allogeneic Umbilical Cord-Derived Cd34- Cells, Non-Expanded are focused on high and very high-risk acute leukemia and myelodysplasia. The main study is a Phase 2 open-label trial in people who need an allogeneic stem cell transplant. Researchers are checking safety, including graft failure, and whether the transplant can be done in a practical way. The key outcome is relapse-free survival at 1 and 2 years after transplant. The planned enrollment for the study is 30 participants.
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. The study is designed to see whether this transplant approach is safe and whether it may help people stay free from relapse after treatment.
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. 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.
The study is interventional, which means the research team gives the study treatment and then follows the results. The trial title also describes it as an open-label study, meaning everyone involved knows what treatment is being used.
What the study measures
The main outcome is relapse-free survival at 1 year and 2 years after transplant. Relapse-free survival means the time after treatment during which the disease does not come back.
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. Graft failure means the transplanted cells do not take hold or do not work as expected.
Trial design and phase
This study is a Phase 2 trial. 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.
The trial is authorised and plans to include 30 participants. The intervention listed in the source is DOROCUBICEL, Allogeneic Umbilical Cord-Derived Cd34- Cells, Non-Expanded, given by intravenous infusion.
Patient-friendly terms
Acute leukemia is a fast-growing cancer of the blood and bone marrow. Myelodysplasia is a disorder where the bone marrow does not make healthy blood cells normally.
Cord blood is blood collected from the umbilical cord after birth, and it can contain stem cells used in transplants. A stem cell transplant is a treatment that replaces damaged blood-forming cells with healthy ones from a donor.
Feasibility means whether the treatment plan can be carried out successfully in real patients. 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.
Trial status and size
The trial status in the source is Authorised. 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.