Chronic Graft vs. Host DiseasePhase 2NCT02322190
Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD
A Phase 2 study testing Extracorporeal Photopheresis (ECP) and Methoxsalen in people with Chronic Graft vs. Host Disease and Graft vs Host Disease, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Some allogeneic stem cell transplant recipients get acute graft-versus-host disease (GVHD). They always get steroids as the first treatment, but this may not work. Those people where steroids are not enough may benefit from a treatment called extracorporeal photopheresis (ECP). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Graft vs. Host Disease, Graft vs Host Disease, Graft-Versus-Host Disease
- What is being tested?
- Extracorporeal Photopheresis (ECP) and Methoxsalen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2014to 31 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to18 years.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Subject must be also enrolled on an National Cancer Institute (NCI) allogeneic transplant protocol.
- Patients must agree to practice effective contraception (both male and female subjects, if the risk of conception exists)The effects of Extracorporeal Photopheresis (ECP) on the developing human fetus are unknown. For this reason and as well as other Methoxsalen used in this trial is in a class of agents that is known to be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for 4 months after the completion of study treatment. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
Who cannot join
- Any physical or mental condition that, in the opinion of the principal Investigator (PI), would cause the risk/benefit ratio of participation to be unacceptable.
- Inclusion of ECP in the treatment of any patient is contraindicated by any of the following:
- Unstable hemodynamics requiring vasopressors or other support measures not amenable to or medically appropriate for continuation during the procedure.
- Uncontrolled infection.
- Inability to maintain acceptable venous access.
- Uncontrolled or uncorrectable coagulopathy.
Show all 10Show fewer
- Pregnant women are excluded from ECP because methoxsalen, an agent utilized for the study procedure, may cause fetal harm. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with methoxsalen, breastfeeding should be discontinued if the mother is treated with methoxsalen. Pregnancy will be evaluated prior to initiation of ECP.
- History of allergic or idiosyncratic/hypersensitivity reactions to 8- methoxypsoralen/psoralen compounds.
- History of a light-sensitive cutaneous disease
- Subjects with aphakia
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Biomarkers in Acute Graft-Versus-Host Disease (GVHD) and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD
Background:
- Some allogeneic stem cell transplant recipients get acute graft-versus-host disease (GVHD). They always get steroids as the first treatment, but this may not work. Those people where steroids are not enough may benefit from a treatment called extracorporeal photopheresis (ECP). ECP exposes white blood cells to ultraviolet light outside the body. Researchers want to study how certain markers in the blood predict the severity and outcome of acute GVHD and how ECP treatments work for people with acute GVHD. They will also study how these markers in the blood may help predict who should get ECP and its effects on the immune system.
Read more
Objectives:
- To learn more about treatments for acute GVHD after allogeneic stem cell transplantation.
Eligibility:
- Adults with acute GVHD enrolled in an National Cancer Institute (NCI) allogeneic transplantation protocol.
Design:
- Transplant physicians will confirm participant eligibility.
- Participants will receive treatment with steroids for their acute GVHD as prescribed by their transplant physician. This will continue while they are enrolled on this study.
- If steroids work in treating their acute GVHD, then every 28 days for 6 months, participants will have:
- a physical exam.
- blood tests.
- If steroids do not work, participants will get additional treatments as prescribed by their transplant physician who may choose to use ECP as a part of this additional treatment. For ECP, blood is removed through an intravenous (IV) catheter. A machine separates the white blood cells from the other blood parts. Those cells are treated with methoxsalen and exposed to ultraviolet light. Then they are returned to the participant through their IV.
- Participants who get ECP will over at least 6 months have:
- veins researched. They may have a catheter placed in a larger vein in the chest or groin.
- multiple blood tests.
- multiple pregnancy tests (if needed).
- multiple ECP procedures.
- At the end of ECP treatment and 6 months after ECP, participants will have additional physical exams and blood tests.
Read the detailed description
Background:
- Acute graft versus host disease (GVHD) remains a difficult to manage complication of allogeneic hematopoietic stem cell transplantation causing significant morbidity and mortality.
- Biomarkers have recently been described in acute GVHD that have the potential to better predict onset, severity, steroid failure, and non-relapse mortality.
- First line treatment of acute GVHD with high dose corticosteroids will fail in approximately 30% of patients and is associated with significant steroid related complications.
- No second line treatment of acute GVHD after a failure of steroids has been established as a standard approach.
- Choice of second line therapy for acute GVHD is currently based primarily on physician familiarity, existing toxicities, and patient's ability to tolerate new potential toxicities.
- Extracorporeal photopheresis (ECP) is an attractive therapy to combine with other therapies for steroid refractory disease due to a unique mechanism of action involving immunomodulation as well as an extremely low rate of reported side effects and complications.
- Biomarkers may also prove useful in predicting the success or failure of specific treatments for steroid refractory disease, including those combined with ECP.
- This study will allow for collection of biomarker data in patients undergoing allogeneic transplantation on National Cancer Institute (NCI) protocols, including those who develop acute GVHD and investigate their role in predicting outcomes in initial corticosteroid therapy as well as in currently used treatments in the management of patients with steroid refractory acute GVHD with or without the addition of ECP.
Objective:
-To study biomarkers in patients undergoing allogeneic transplantation, with acute GVHD including their ability to predict steroid refractoriness and predict outcome of investigator chosen second line therapies with and without Extracorporeal Photopheresis (ECP).
Eligibility:
- Adult patients on an NCI allogeneic transplantation protocol.
Design:
- Non-randomized, single institution study.
- Research blood for biomarkers will be collected on all patients enrolled.
- ECP will be offered as an addition to investigator chosen treatments in patients who develop steroid refractory acute GVHD.
- The study will enroll a total of up to 450 patients.
- Being tested
- Extracorporeal Photopheresis (ECP), Methoxsalen
- Keywords
- Steroid Failure, Immunomodulation, Corticosteroid Therapy
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Photopheresis (ECP)Procedure or surgery
Also called Extracorporeal Photopheresis
Twice weekly for 1 month or Twice every other week for 2 months or Twice during one week per month for 4 months for a total of up to 7 months of treatment.
MethoxsalenDrug
Also called Oxsoralen-Ultra
Sterile solution used in conjunction with photopheresis procedure.
| Study group | Role | What they receive |
|---|---|---|
| Investigator chosen second line therapy | No intervention | Investigator chosen second line therapy |
| Second line therapy + Extracorporeal Photopheresis | Experimental | Second line therapy in addition to Extracorporeal Photopheresis (ECP) Receives: Procedure: Extracorporeal Photopheresis (ECP); Drug: Methoxsalen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Biomarkers (Serum TIM3, IL-6, Reg-3-a, ST2, LPS-BP, Nitrate, TNFR1, IL-2Ra, CXCL10, and HGF) Present in Blood and/or Tissue Who Were Steroid Refractory After ECP Treatment
In an effort to determine steroid refractoriness after Extracorporeal Photopheresis (ECP) treatment, tissue and blood obtained from participants was examined to see if biomarkers (i.e., Serum T cell immunoglobulin and mucin domain-containing protein 3 (TIM3), ST2, Nitrate, Interleukin-6 (IL-6), regenerating family member 3 alpha (Reg-3-a), lipopolysaccharide binging protein (LPS-BP), tumor necrosis factor receptor 1 (TNFR1), interleukin-2 receptor alpha chain (IL-2Ra), CXC motif chemokine 10 (CXCL10), hepatocyte growth factor (HGF)) were present.
Measured: 14 Days
Number of Participants With Steroid Refractory Disease Who Had Improvement and/or Resolution of Graft-versus-host Disease (GVHD) Associated Symptoms
GVHD associated symptoms was assessed by the American Society for Bone Marrow Transplantation consensus statement. Complete Response (CR) is no residual organ specific symptoms or findings. Very Good Partial Response (VGPR) is Skin: An active erythematous rash involving < 25% of the body surface area; Liver: Persistent low-level hyperbilirubinemia, and/or Gut: Gastrointestinal function and water resorption in the colon are approaching normal. Partial Response (PR) is any improvement over baseline symptoms. Progressive disease (PD) is stable or worsening organ specific findings requiring change of therapy.
Measured: 7 months
Secondary outcomes (2)
Days to Overall Survival
Overall survival is defined as the time from study entry to end of observations/off study.
Measured: time from study entry to end of observations/off study, up to a year
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Measured: Date treatment consent signed to date off study, approximately 8 months and 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start20 Dec 2014
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Why it stopped: Due to slow/insufficient accrual and Principal Investigator left the NIH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Graft vs. Host DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Ronald Gress, M.D., National Cancer Institute (NCI)
- Investigators
- Ronald E Gress, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322190
- Sponsor's protocol ID
- 150039
- Other IDs
- 15-C-0039
- Status last verified
- Mar 2020
- First submitted
- 20 Dec 2014
- Last updated
- 12 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Acute Graft-Versus-Host Disease (GVHD) and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD
- ClinicalTrials.gov ID
- NCT02322190
- Acronym / sponsor ID
- 150039
- Keywords
- Steroid Failure, Immunomodulation, Corticosteroid Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow/insufficient accrual and Principal Investigator left the NIH
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 20 Dec 2014 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Posted 12 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Some allogeneic stem cell transplant recipients get acute graft-versus-host disease (GVHD). They always get steroids as the first treatment, but this may not work. Those people where steroids are not enough may benefit from a treatment called extracorporeal photopheresis (ECP). ECP exposes white blood cells to ultraviolet light outside the body. Researchers want to study how certain markers in the blood predict the severity and outcome of acute GVHD and how ECP treatments work for people with acute GVHD. They will also study how these markers in the blood may help predict who should get ECP and its effects on the immune system.
Objectives:
- To learn more about treatments for acute GVHD after allogeneic stem cell transplantation.
Eligibility:
- Adults with acute GVHD enrolled in an National Cancer Institute (NCI) allogeneic transplantation protocol.
Design:
- Transplant physicians will confirm participant eligibility.
- Participants will receive treatment with steroids for their acute GVHD as prescribed by their transplant physician. This will continue while they are enrolled on this study.
- If steroids work in treating their acute GVHD, then every 28 days for 6 months, participants will have:
- a physical exam.
- blood tests.
- If steroids do not work, participants will get additional treatments as prescribed by their transplant physician who may choose to use ECP as a part of this additional treatment. For ECP, blood is removed through an intravenous (IV) catheter. A machine separates the white blood cells from the other blood parts. Those cells are treated with methoxsalen and exposed to ultraviolet light. Then they are returned to the participant through their IV.
- Participants who get ECP will over at least 6 months have:
- veins researched. They may have a catheter placed in a larger vein in the chest or groin.
- multiple blood tests.
- multiple pregnancy tests (if needed).
- multiple ECP procedures.
- At the end of ECP treatment and 6 months after ECP, participants will have additional physical exams and blood tests.
Detailed description
Background:
- Acute graft versus host disease (GVHD) remains a difficult to manage complication of allogeneic hematopoietic stem cell transplantation causing significant morbidity and mortality.
- Biomarkers have recently been described in acute GVHD that have the potential to better predict onset, severity, steroid failure, and non-relapse mortality.
- First line treatment of acute GVHD with high dose corticosteroids will fail in approximately 30% of patients and is associated with significant steroid related complications.
- No second line treatment of acute GVHD after a failure of steroids has been established as a standard approach.
- Choice of second line therapy for acute GVHD is currently based primarily on physician familiarity, existing toxicities, and patient's ability to tolerate new potential toxicities.
- Extracorporeal photopheresis (ECP) is an attractive therapy to combine with other therapies for steroid refractory disease due to a unique mechanism of action involving immunomodulation as well as an extremely low rate of reported side effects and complications.
- Biomarkers may also prove useful in predicting the success or failure of specific treatments for steroid refractory disease, including those combined with ECP.
- This study will allow for collection of biomarker data in patients undergoing allogeneic transplantation on National Cancer Institute (NCI) protocols, including those who develop acute GVHD and investigate their role in predicting outcomes in initial corticosteroid therapy as well as in currently used treatments in the management of patients with steroid refractory acute GVHD with or without the addition of ECP.
Objective:
-To study biomarkers in patients undergoing allogeneic transplantation, with acute GVHD including their ability to predict steroid refractoriness and predict outcome of investigator chosen second line therapies with and without Extracorporeal Photopheresis (ECP).
Eligibility:
- Adult patients on an NCI allogeneic transplantation protocol.
Design:
- Non-randomized, single institution study.
- Research blood for biomarkers will be collected on all patients enrolled.
- ECP will be offered as an addition to investigator chosen treatments in patients who develop steroid refractory acute GVHD.
- The study will enroll a total of up to 450 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigator chosen second line therapy | No intervention | –Investigator chosen second line therapy |
| Second line therapy + Extracorporeal Photopheresis | Experimental | Procedure: Extracorporeal Photopheresis (ECP), Drug: MethoxsalenSecond line therapy in addition to Extracorporeal Photopheresis (ECP) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to18 years.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Subject must be also enrolled on an National Cancer Institute (NCI) allogeneic transplant protocol.
- Patients must agree to practice effective contraception (both male and female subjects, if the risk of conception exists)The effects of Extracorporeal Photopheresis (ECP) on the developing human fetus are unknown. For this reason and as well as other Methoxsalen used in this trial is in a class of agents that is known to be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for 4 months after the completion of study treatment. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (10 listed)
- Any physical or mental condition that, in the opinion of the principal Investigator (PI), would cause the risk/benefit ratio of participation to be unacceptable.
- Inclusion of ECP in the treatment of any patient is contraindicated by any of the following:
- Unstable hemodynamics requiring vasopressors or other support measures not amenable to or medically appropriate for continuation during the procedure.
- Uncontrolled infection.
- Inability to maintain acceptable venous access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Photopheresis (ECP)Also: Extracorporeal PhotopheresisTwice weekly for 1 month or Twice every other week for 2 months or Twice during one week per month for 4 months for a total of up to 7 months of treatment. | Procedure or surgery | Second line therapy + Extracorporeal Photopheresis |
| MethoxsalenAlso: Oxsoralen-UltraSterile solution used in conjunction with photopheresis procedure. | Drug | Second line therapy + Extracorporeal Photopheresis |
Primary outcome
Number of Participants With Biomarkers (Serum TIM3, IL-6, Reg-3-a, ST2, LPS-BP, Nitrate, TNFR1, IL-2Ra, CXCL10, and HGF) Present in Blood and/or Tissue Who Were Steroid Refractory After ECP Treatment
Time frame: 14 Days
In an effort to determine steroid refractoriness after Extracorporeal Photopheresis (ECP) treatment, tissue and blood obtained from participants was examined to see if biomarkers (i.e., Serum T cell immunoglobulin and mucin domain-containing protein 3 (TIM3), ST2, Nitrate, Interleukin-6 (IL-6), regenerating family member 3 alpha (Reg-3-a), lipopolysaccharide binging protein (LPS-BP), tumor necrosis factor receptor 1 (TNFR1), interleukin-2 receptor alpha chain (IL-2Ra), CXC motif chemokine 10 (CXCL10), hepatocyte growth factor (HGF)) were present.
Number of Participants With Steroid Refractory Disease Who Had Improvement and/or Resolution of Graft-versus-host Disease (GVHD) Associated Symptoms
Time frame: 7 months
GVHD associated symptoms was assessed by the American Society for Bone Marrow Transplantation consensus statement. Complete Response (CR) is no residual organ specific symptoms or findings. Very Good Partial Response (VGPR) is Skin: An active erythematous rash involving < 25% of the body surface area; Liver: Persistent low-level hyperbilirubinemia, and/or Gut: Gastrointestinal function and water resorption in the colon are approaching normal. Partial Response (PR) is any improvement over baseline symptoms. Progressive disease (PD) is stable or worsening organ specific findings requiring change of therapy.
2 secondary outcomes
Days to Overall Survival
Time frame: time from study entry to end of observations/off study, up to a year
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).
Time frame: Date treatment consent signed to date off study, approximately 8 months and 6 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald E Gress, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extracorporeal Photopheresis (ECP) and Methoxsalen in people with Chronic Graft vs. Host Disease and Graft vs Host Disease, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Biomarkers (Serum TIM3, IL-6, Reg-3-a, ST2, LPS-BP, Nitrate, TNFR1, IL-2Ra, CXCL10, and HGF) Present in Blood and/or Tissue Who Were Steroid Refractory After ECP Treatment (time frame: 14 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.