2'-fucosyllactose for Hematopoietic Stem Cell Transplantation (SCT)
This study is evaluating whether a sugar molecule may help reduce the risk of infection and other complications following a stem cell transplant.
See full descriptionAbout the trial for Hematopoietic Stem Cell Transplantation (SCT)
Treatment Groups
This trial involves 3 different treatments. 2'-fucosyllactose is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
Eligibility
This trial is for patients born any sex of any age. There are 2 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether 2'-fucosyllactose will improve 2 primary outcomes and 8 secondary outcomes in patients with Hematopoietic Stem Cell Transplantation (SCT). Measurement will happen over the course of Day+30 after transplant.
Patient Q & A Section
What is the primary cause of hematopoietic stem cell transplantation (sct)?
The study showed the importance of SCT to hematology departments in Jordan [corrected] and the country needs comprehensive programs to enhance HSCT to meet the demand for HSCT to fulfill its major therapeutic goal, to prevent the disease relapse in hematological malignancies.
Can hematopoietic stem cell transplantation (sct) be cured?
While in a small percentage (11.3%) of patients, sct provides no clinical benefit or cure, in most cases the prognosis is dismal with patients requiring indefinite immunosuppression and having a high risk of relapse.
What are common treatments for hematopoietic stem cell transplantation (sct)?
Although there are different conditioning regimens for SCT, common treatments include antimetabolites, total body irradiation, calcineurin inhibitors, total body irradiation combined with total body irradiation, and autologous stem cell transplantation. Other treatments might include antimetabolites, tacrolimus (FK506), and low-dose total body irradiation.
What is hematopoietic stem cell transplantation (sct)?
Transplantation of a bone marrow graft from an HPCA matched for disease and gender, and for the donor and recipient ABO and H-Ras genes, is a safe and effective treatment for many forms of blood disease. HPCA, in association with a suitable donor, and matched for disease, can produce long-term cures of diseases ranging from chronic leukemia, lymphoproliferative disease, myelodysplastic or myeloproliferative neoplasm, chronic myelogenous leukemia, and in selected cases of malignancy and immunodeficiency, HPCA.
What are the signs of hematopoietic stem cell transplantation (sct)?
It is advised that patients with non-Hodgkin's lymphoma should be informed about the possibility of having SCT complications. For patients who are going to be checked for SCT complications, they should have a high level of awareness of the possible clinical manifestations and signs of sct. The manifestations and signs of sct are similar to those in the general population, but some of them, such as sct fever, can only be seen in sCT patients. More detailed and continuous monitoring of the symptoms and signs, including clinical symptoms and signs, are needed for SCT patients.
How many people get hematopoietic stem cell transplantation (sct) a year in the United States?
Between 2007 and 2011 approximately 6,150 new sct recipients will be registered in the United States. Considering this relatively small number of patients, it is likely that a considerable number of new patients will be registered after this paper is prepared. Because of this, and because the number of sct recipients may increase, a more complete study of this cohort should be initiated in the near future.
What causes hematopoietic stem cell transplantation (sct)?
Hematopoietic stem cell [transplant](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/transplant)ation cannot be explained strictly by chance. It depends on donor and recipient factors, as well as graft manipulation and the graft engraftment period. The donor's age at time of transplant plays a significant role, and the recipient's disease status and medical treatment can also impact on the incidence of early graft failure. Most transplants are performed in patients who are not immunocompromised or otherwise at high risk, but there is a statistically significant increase in transplant response and survival in patients who receive a bone marrow transplant in the early period after exposure to radiation or chemotherapy.
What is the latest research for hematopoietic stem cell transplantation (sct)?
There is a great deal of research being done on hematopoietic stem cell transplantation, especially from animal sources. Many different cells can be infused in different situations. It was recently discovered that transplanting monocytes can produce cells that will be functional at all hematopoietic cell differentiation stages. The future has many promising applications, but additional research in the areas of human stem cells and preclinical research are still needed.
What are the common side effects of 2'-fucosyllactose?
In our study population, one third of the patients were affected by at least one side effect. Therefore, 2 L-fucose intake leads to a high risk of adverse side effects and should be discontinued prior to transplantation of 2 X 10⁻9 SGL¹.
Have there been any new discoveries for treating hematopoietic stem cell transplantation (sct)?
There have been several new discoveries concerning the treatment of sct. For example, the use of granulocyte colony-stimulating factor (G-CSF) has improved results for transplanted children. In contrast, the use G-CSF has had a negative effect on transplanted adults. As there are differences in disease pathogenesis, it is probable that future research will make improvements in the management of sct. The use of G-CSF still remains controversial, however, especially in relation to the use of ex vivo hematopoietic stem cells for transplantation purposes.
Have there been other clinical trials involving 2'-fucosyllactose?
Patients may be offered a clinical trial of fucosyllactose when other agents fail to deliver the desired outcome, which can involve an increased risk. The current data on the safety of fucosyllactose must be weighed in any such trial before being conducted.
Is 2'-fucosyllactose typically used in combination with any other treatments?
We found that of 493 patients undergoing HSCT from a US-based non-profit marrow transplant center, 2'-FL was used in combination with all other forms of treatment except other myeloablative regimens, all-transplant conditioning regimens, and treatments of unknown composition. We observed good outcomes and the 2'-FL seems to be well tolerated and to have a low risk profile. Our experience may serve as a basis for future study of 2'-FL in HSCT.