CLINICAL TRIAL

2'-fucosyllactose for Hematopoietic Stem Cell Transplantation (SCT)

Recruiting · Any Age · All Sexes · Cincinnati, OH

This study is evaluating whether a sugar molecule may help reduce the risk of infection and other complications following a stem cell transplant.

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About 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.

Experimental Group 1
2'-fucosyllactose
DRUG
Experimental Group 2
2'-fucosyllactose
DRUG
Control Group 3
Placebo (2g oral glucose)
OTHER

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Be scheduled for allogeneic stem cell transplant
All ages and underlying diagnoses, preparative regimens, stem cell sources and acute GVHD prophylaxes
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Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 week prior to start of chemotherapy until day+30 after transplant
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 week prior to start of chemotherapy until day+30 after transplant
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 week prior to start of chemotherapy until day+30 after transplant.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Plasma reg 3- alpha levels at day+30 in 2FL patients compared to placebo
DAY+30 AFTER TRANSPLANT
Lower plasma reg 3- alpha levels at day+30 in 2FL patients compared to placebo
DAY+30 AFTER TRANSPLANT
Plasma cytokines (IL6, IL8, IL10 and IFNγ) at day+30 in 2FL group compared to placebo
DAY+30 AFTER TRANSPLANT
Lower plasma cytokines (IL6, IL8, IL10 and IFNγ) at day+30 in 2FL group compared to placebo
DAY+30 AFTER TRANSPLANT
Fecal human DNA at day+30 in 2FL group compared to placebo
DAY+30 AFTER TRANSPLANT
Lower fecal human DNA at day+30 in 2FL group compared to placebo
DAY+30 AFTER TRANSPLANT
Relative abundance of fecal Firmicutes and Proteobacteria at day+30 compared to baseline for patients on 2FL
DAY+30 AFTER TRANSPLANT
Change in relative abundance of fecal Firmicutes and Proteobacteria at day+30 compared to baseline for patients on 2FL
DAY+30 AFTER TRANSPLANT
Relative abundance of fecal Bifidobacteria at day+30 compared to baseline by >/=10%
DAY+30 AFTER TRANSPLANT
Change in relative abundance of fecal Bifidobacteria at day+30 compared to baseline by >/=10%
DAY+30 AFTER TRANSPLANT
CD69+ CD8+T-cells at day+30 in 2FL patients compared to placebo.
DAY+30 AFTER TRANSPLANT
Lower CD69+ CD8+T-cells at day+30 in 2FL patients compared to placebo.
DAY+30 AFTER TRANSPLANT
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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