Trial · NCT02322190
Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD
NCT02322190, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2020-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD. Trials, record NCT02322190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02322190
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD
- NCT number
- NCT02322190
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Chronic Graft vs. Host Disease, Graft vs Host Disease, Graft-Versus-Host Disease
- Interventions
- Extracorporeal Photopheresis (ECP), Methoxsalen
- First posted
- 2014-12-23
- Last updated
- 2020-03-12
- Results first posted
- 2020-03-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Primary | Number of Participants With Steroid Refractory Disease Who Had Improvement and/or Resolution of Graft-versus-host Disease (GVHD) Associated Symptoms | 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. |
| Secondary | Days to Overall Survival | time from study entry to end of observations/off study, up to a year | Overall survival is defined as the time from study entry to end of observations/off study. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Date treatment consent signed to date off study, approximately 8 months and 6 days | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 14 Days | No data was collected for this outcome measure and it not done because biomarker studies require large patient numbers to analyze data. Only five participants were enrolled in this study. With early termination, there are no biomarker data to report. | ||
| PRIMARY | Number of Participants With Steroid Refractory Disease Who Had Improvement and/or Resolution of Graft-versus-host Disease (GVHD) Associated Symptoms | 7 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Days to Overall Survival | time from study entry to end of observations/off study, up to a year | Days | MEDIAN | |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Date treatment consent signed to date off study, approximately 8 months and 6 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Steroid Refractory Disease Who Had Improvement and/or Resolution of Graft-versus-host Disease (GVHD) Associated Symptoms | Investigator Chosen Second Line Therapy | 2 | Participants | ||
| Days to Overall Survival | Investigator Chosen Second Line Therapy | 180 | Full Range 117 to 318 | Days | |
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Investigator Chosen Second Line Therapy | 1 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Investigator Chosen Second Line Therapy | 5 | |
| Overall Study | STARTED | Second Line Therapy + Extracorporeal Photopheresis | 0 | |
| Overall Study | COMPLETED | Investigator Chosen Second Line Therapy | 4 | |
| Overall Study | COMPLETED | Second Line Therapy + Extracorporeal Photopheresis | 0 | |
| Overall Study | NOT COMPLETED | Investigator Chosen Second Line Therapy | 1 | |
| Overall Study | NOT COMPLETED | Second Line Therapy + Extracorporeal Photopheresis | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Death | General disorders | Investigator Chosen Second Line Therapy | 1 | 5 | 1 |
| serious | Death | General disorders | Second Line Therapy + Extracorporeal Photopheresis | 0 | 0 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Investigator Chosen Second Line Therapy | 1 | 5 |
| Total, all-cause mortality | Second Line Therapy + Extracorporeal Photopheresis | 0 | 0 |
| Total, other adverse events | Investigator Chosen Second Line Therapy | 0 | 5 |
| Total, other adverse events | Second Line Therapy + Extracorporeal Photopheresis | 0 | 0 |
| Total, serious adverse events | Investigator Chosen Second Line Therapy | 1 | 5 |
| Total, serious adverse events | Second Line Therapy + Extracorporeal Photopheresis | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02322190
GET https://conductscience.org/api/trials/v1/NCT02322190/registered