Extracorporeal Photopheresis for Graft vs Host Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
City of Hope Medical Center, Duarte, CA
Graft vs Host Disease+1 More
Extracorporeal Photopheresis - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether extracorporeal photopheresis and low dose aldesleukin are effective in treating patients with chronic graft-vs-host disease.

See full description

Eligible Conditions

  • Graft vs Host Disease
  • Chronic Graft Versus Host Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Graft vs Host Disease

Study Objectives

This trial is evaluating whether Extracorporeal Photopheresis will improve 1 primary outcome and 9 secondary outcomes in patients with Graft vs Host Disease. Measurement will happen over the course of Up to 4 weeks after the end of treatment.

Week 4
Change in immunologic function
Year 4
Overall survival
Year 4
Non-relapse mortality
Year 4
Failure-free survival
Up to 16 weeks
Chronic GVHD symptom score using the GVHD Symptom Scale
Week 4
ECP performance parameters will be analyzed based on Flow rates during each ECP session.
ECP performance parameters will be analyzed based on Median time spent for each ECP session.
ECP performance parameters will be analyzed based on Outcomes based on use of second or third generation devices.
Incidence of adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Overall response (CR+ PR+SD) based on the National Institutes of Health cGVHD consensus criteria

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Graft vs Host Disease

Trial Design

1 Treatment Group

Supportive care (aldesleukin and ECP)
1 of 1
Experimental Treatment

This trial requires 24 total participants across 1 different treatment group

This trial involves a single treatment. Extracorporeal Photopheresis 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.

Supportive care (aldesleukin and ECP)Patients receive aldesleukin SC daily for 12 weeks. Patients also undergo ECP twice weekly on weeks 1-4 and then receive 2 ECP treatments every 2 weeks on weeks 5-12. Patients responding to upfront therapy with aldesleukin and ECP have the option to continue combination therapy per the discretion of the treating physician until clinical benefit is maintained or toxicities develop.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
FDA approved
Extracorporeal Photopheresis
2004
Completed Phase 2
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of first dose of study drug to date of death from any cause, assessed up to 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from date of first dose of study drug to date of death from any cause, assessed up to 4 years for reporting.

Closest Location

City of Hope Medical Center - Duarte, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Graft vs Host Disease or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who receive allogeneic stem cell transplants, with either myeloablative or non-myeloablative conditioning regimens, are allowed to have alternative donor transplants, such as umbilical cord blood or haploidentical transplants. show original
People with cGVHD that doesn't get better even after taking prednisone for at least 4 weeks are defined as having steroid-refractory cGVHD. show original
Saying that someone has an "estimated life expectancy greater than 3 months" means that they are likely to live for 3 more months or more. show original
Women of child-bearing potential and men must agree to use contraception prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately. show original
If you have abnormal liver function tests (LFTs) and you are also experiencing other organ system involvement from cGVHD, your doctor may allow them if they document that the LFTs are consistent with hepatic cGVHD show original
The patient's steroid dose (mg/kg) will remain unchanged for the 2 weeks preceding enrollment; allowances will be made for up or down titrating the dose based on changes in body weight. show original
, in which case AST/ALT ≥ 5 x ULN If serum AST (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) is 2 times the upper limit of normal or less (unless hepatic dysfunction is a manifestation of presumed cGVHD, in which case AST/ALT is ≥ 5 times the upper limit of normal), it is considered a low risk. show original
The Karnofsky performance status of 70-100 % means that the person is able to carry out normal activities and is not bedridden. show original
for this study People who have chronic GVHD that requires systemic therapy are able to participate in this study. show original
This means that the total bilirubin in the blood must be less than 2.0 mg/dl, with the exception of patients who have Gilbert's syndrome show original

Patient Q&A Section

Can graft vs host disease be cured?

"A recent study with a large number of subjects showed that, in most cases, the GvsD could not be cured. In fact GvsD is the most important effect of allogeneic transplantation and the main reason to avoid it." - Anonymous Online Contributor

Unverified Answer

What are common treatments for graft vs host disease?

"Most patients present with the symptoms of GvHD, and even though some of these symptoms may be manageable through conventional treatment, the treatment of GvHD may require the use of a broad range of drugs and/or therapies, depending on one's clinical situation." - Anonymous Online Contributor

Unverified Answer

What is graft vs host disease?

"GvHD is an immune-mediated complication associated with immunosuppressive treatment of the graft. It is characterized by transplanted tissue destroying its own host. GvHD can cause symptoms from skin rashes to severe life-threatening disorders (myeloproliferative disorders) and systemic symptoms. GvHD is the most serious side effect associated with both T cell and B cell-targeted therapies in both allotransplantation and autotransplantation. GvHD in transplantation is often accompanied by the development of autoantibodies against mismatched human leukocyte antigen (HLA) antigens. We discuss the pathophysiology of GvHD." - Anonymous Online Contributor

Unverified Answer

What are the signs of graft vs host disease?

"Graft vs host disease can occur more than 12 months after the first clinical presentation of graft vs host disease, but is often under-detected. Therefore, clinical suspicion should be high when diagnosing graft vs host disease. Most individuals with cPAN have no symptoms in the early stages of the condition." - Anonymous Online Contributor

Unverified Answer

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

"About 10-20% of patients who receive allogeneic bone marrow transplants experience GVHD, and 5% of patients who receive an HLA-identical sibling allogeneic bone marrow transplant experience GVHD. It occurs most often in the first six months after transplantation and increases to an incidence of 17% by year 2. The risk factors that are associated with a high incidence of GVHD include older age (at the time of transplantation), prior history of GVHD, prior conditioning regimen, and the use of a T-cell depleted or MHC-matched bone marrow transplant." - Anonymous Online Contributor

Unverified Answer

What causes graft vs host disease?

"The presence of T-cell-depleted blood within a bone marrow graft increases the risk of GvHD. The use of HLA-alloimmunosuppressive antisera or bone marrow cell depletion of the graft also increases the risk of GvHD. The role of GvHD as a cause of delayed graft function warrants further investigation." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for graft vs host disease?

"Since results from a recent trial in children suggest that anti-Thy-1 antibodies (against a T-cell surface antigen) can be effective in limiting the severity and severity of GvHD in pediatric patients, we suggest that anti-Thy-1 antibodies may offer an efficacious treatment for GvHD." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of extracorporeal photopheresis?

"Extracorporeal photopheresis had severe side effects in this study population. A variety of side effects appeared in approximately two-thirds of the patients in the study. Side effects occurred frequently and were severe including rash, hypotension, bronchospasm, and anaphylaxis. ECP has few uses other than autoimmunity. For many patients in this study, ECP did not significantly improve disease status. Further work is needed to identify the mechanisms that cause side effects and the best method of safely integrating this treatment in the management of SLE patients." - Anonymous Online Contributor

Unverified Answer

Is extracorporeal photopheresis safe for people?

"This is the largest series yet to report on ECP. A prospective, randomized, control trial would be worthwhile to assess its outcome in comparison to traditional therapies like splenectomy, bone marrow transplantation and/or steroid therapy." - Anonymous Online Contributor

Unverified Answer

How serious can graft vs host disease be?

"GVHD is very uncommon and is mostly moderate and mild grade. It has no effect or only affects mildly on life expectancy of the patient but should be regarded as a possible complication after allogeneic HSCT." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating graft vs host disease?

"There have been many new discoveries to treat the symptoms of GVHD but there is no one cure to treat this disease. Most people are left with a variety of treatment options to help them live their life freely after having GVHD. Patients who receive a full treatment regimen can be cured with less severe symptoms compared to those who don’t get a full treatment regimen. It may lead to a full recovery once GVHD is treated aggressively and fully." - Anonymous Online Contributor

Unverified Answer

What is extracorporeal photopheresis?

"Treatment with ECP has no effect on the incidence or severity of GVHD.[Citations needed(10)] ECP treatment has, however, been shown to be effective to reduce the frequency of infections. ECP should no longer be used for these indications. At this time we are not recommending ECP for the treatment of GVHD associated with HSCT. However, when applicable ECP may be an effective treatment for severe and refractory GVHD." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Graft vs Host Disease by sharing your contact details with the study coordinator.