CLINICAL TRIAL

Treatment for Graft vs Host Disease

Waitlist Available · < 65 · All Sexes · Boston, MA

This study is evaluating whether a drug called vancopoly can prevent or treat acute graft-versus-host disease.

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About the trial for Graft vs Host Disease

Eligible Conditions
Graft vs Host Disease · Acute Graft-Versus-Host Disease (GVHD) · Hematopoietic Stem Cell Transplantation (SCT)

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Vancomycin-polymyxin B
DRUG

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The study participants must be at least 4 years old and toilet-trained in order to provide stool samples directly into the collection containers show original
People in the study may have an underlying illness that caused their blood disorder, except for a primary immune deficiency show original
People who take part in this study will either receive a myeloablative or non-myeloablative(reduced-intensity) conditioning regimen show original
GVHD is prevented with the use of calcineurin inhibitors, short-course methotrexate, mycophenolate mofetil, and sirolimus. show original
prior to enrollment The parents or guardians of the participants must be willing to sign a written consent form prior to their child's enrollment in the study. show original
Eligibility Criteria for Healthy Bone Marrow Donors
Eligibility Criteria for Patients Undergoing Allogeneic HSCT
A person who has a 9/10 or 10/10 HLA-A, -B, -C, -DRB1, -DQB1 match for a bone marrow allogeneic hematopoietic stem cell transplantation (HSCT) or a 4/6, 5/6, and 6/6 HLA-A, -B, -DR match for a cord blood allogeneic HSCT is a good candidate for this type of transplant. show original
The person has a Lansky/Karnofsky performance status of ≥60% (see Appendix A). show original
Healthy individuals who are at least 4 years old and have been toilet-trained can participate in this study show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.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: Time from randomization to the earlier of progression of malignant disease or death due to any cause. All participants will be followed for 2 years after study entry.
Screening: ~3 weeks
Treatment: Varies
Reporting: Time from randomization to the earlier of progression of malignant disease or death due to any cause. All participants will be followed for 2 years after study entry.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Time from randomization to the earlier of progression of malignant disease or death due to any cause. All participants will be followed for 2 years after study entry..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Graft vs Host Disease. Measurement will happen over the course of 2 Weeks post HSCT.

Gut Microbiome Description
2 WEEKS POST HSCT
Shannon diversity index (range: 0-6), measured at 2 weeks post-HSCT.
2 WEEKS POST HSCT
Stool Frequency
7 DAYS POST-HSCT
7 DAYS POST-HSCT
Presence of Acute GVHD
EACH STOOL COLLECTION TIME POINT AFTER NEUTROPHIL ENGRAFTMENT UNTIL DAY +100
EACH STOOL COLLECTION TIME POINT AFTER NEUTROPHIL ENGRAFTMENT UNTIL DAY +100
Immune cell profiling: Absolute cell numbers of T-, B-, NK- and dendritic cell subsets by flow cytometry
PERFORMED PRIOR TO DAY -5 AND AT THE POST-TRANSPLANT TIME POINTS (1,2,3,6,9,12,18 AND 24 MONTHS POST-TRANSPLANT)
PERFORMED PRIOR TO DAY -5 AND AT THE POST-TRANSPLANT TIME POINTS (1,2,3,6,9,12,18 AND 24 MONTHS POST-TRANSPLANT)
Progression Free Survival
TIME FROM RANDOMIZATION TO THE EARLIER OF PROGRESSION OF MALIGNANT DISEASE OR DEATH DUE TO ANY CAUSE. ALL PARTICIPANTS WILL BE FOLLOWED FOR 2 YEARS AFTER STUDY ENTRY.
TIME FROM RANDOMIZATION TO THE EARLIER OF PROGRESSION OF MALIGNANT DISEASE OR DEATH DUE TO ANY CAUSE. ALL PARTICIPANTS WILL BE FOLLOWED FOR 2 YEARS AFTER STUDY ENTRY.
Overall Survival
TIME FROM RANDOMIZATION TO DEATH DUE TO ANY CAUSE, OR CENSORED AT DATE LAST KNOWN ALIVE. ALL PARTICIPANTS WILL BE FOLLOWED FOR 2 YEARS AFTER STUDY ENTRY.
TIME FROM RANDOMIZATION TO DEATH DUE TO ANY CAUSE, OR CENSORED AT DATE LAST KNOWN ALIVE. ALL PARTICIPANTS WILL BE FOLLOWED FOR 2 YEARS AFTER STUDY ENTRY.

Who is running the study

Principal Investigator
L. L.
Leslie Lehmann, Principal Investigator
Dana-Farber Cancer Institute

Patient Q & A Section

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

How many people get graft vs host disease a year in the United States?

In contrast to other studies, a relatively large number of patients with G-ALL got transplanted: 44 of 101 patients got G-ALL transplanted. Graft vs host disease is one of the main transplant-related complications and was the most frequently observed treatment-related complication.

Anonymous Patient Answer

Can graft vs host disease be cured?

GvHD is a treatment-related complication. However, it can be managed safely by controlling inflammatory reactions to GvHD therapy through corticosteroids, alemta, and monosymapentapeptide. Treatment can stop the clinical manifestations of GvHD, but cannot destroy it, and the risk of chronic GvHD remains the longest-lasting risk.

Anonymous Patient Answer

What is graft vs host disease?

Graft versus host disease represents a challenge in living donor [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation. In the absence of donor-specific antibodies, the risk is moderate. Graft biopsy seems to have limited usefulness in the decision to reject a kidney at the time of its transplant.

Anonymous Patient Answer

What causes graft vs host disease?

Because of the number of hypotheses about what agents are associated with the development of GvHD, we believe that an acceptable causal framework was identified using this review.

Anonymous Patient Answer

What are common treatments for graft vs host disease?

Graft vs host disease is a common complication of hematopoietic stem cell transplantation (and other situations), and a number of methods have been used to attempt preemptive or ameliorative methods. A wide variety of treatments exist for graft vs host disease, which can entail many medications. Steroids, donor-specific antibodies (DSAs), immunosuppressive agents, and antilymphocyte globulin treatment exist.

Anonymous Patient Answer

What are the signs of graft vs host disease?

Nonspecific symptoms after allogeneic bone marrow transplantation include fatigue, malaise, weight loss, and edema (possible GVHD). Additional nonspecific symptoms that occur more commonly post-alloHSCT include headache, nausea, vomiting, diarrhea, mouth ulcer, itching, fatigue, and skin nodules. Other symptoms that occur less commonly include unexplained malaise or unexplained lethargy.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

There is insufficient evidence from controlled trials to determine if the relative effectiveness of an immunosuppressive agent is any different from that of a placebo. However, immunosuppressants may accelerate recurrence of skin transplantations and cause transplant rejection. As such, they are not recommended in all cases of skin transplantation.

Anonymous Patient Answer

How does treatment work?

Patients with graft versus host disease (GVHD) can be treated based on clinical trials for autoimmune diseases, and in the absence of a clinical trial, therapies are likely to be trial-based and disease-specific. As our understanding of graft vs host disease advances and the therapeutic range narrows, some patients will have an appropriate therapy but may be overlooked.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

A significant proportion of patients receiving haematopoietic stem cell transplantation with reduced intensity conditioning did not receive treatment after transplantation. Allograft/autograft has a long-term effect on overall health status. Autologous transplant may be more effective but allograft transplant should be considered for patients with severe diseases such as the high-risk transplants.

Anonymous Patient Answer

What is the average age someone gets graft vs host disease?

There is some variability in the results reported in the literature. If the average age at which GBHA occurs is 24.3, and if this date was used as a standard of reference for GBHAD in the review, then this could mean that we may reasonably expect to see a 50% incidence of GBHAD. However, the majority of the evidence for GBHAD has been published from the 1960s and 1970s and may be based on a fairly arbitrary standard of reference. As such, further work on a more detailed definition of GBHAD is urgently needed to improve the accuracy of what we already know about this potentially serious problem.

Anonymous Patient Answer

Does treatment improve quality of life for those with graft vs host disease?

Findings from a recent study demonstrates that while G-VL has a considerable impact on physical functioning and QoL, it does improve the perceived quality of life of a patient with GVHD. However, there was minimal effect overall on the perceived social or environmental QoL, which indicates that there are more issues to look at in determining the overall impact of the disease.

Anonymous Patient Answer

What does treatment usually treat?

This questionnaire helps surgeons tailor treatment plans to their individual cases. While routine clinical presentation, stage, and history help in making a clinical decision, we do not have a good way to predict the aggressiveness of a patient's disease or the benefit from a prospective clinical trial.

Anonymous Patient Answer
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