A New ECP Protocol for the Treatment of cGVHD
NCT07918547, Not applicable, Not yet recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A New ECP Protocol for the Treatment of cGVHD | ClinicalTrials.gov |
| NCT number | NCT07918547 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 54 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | ClinicalTrials.gov |
| Conditions | Chronic Graft Versus Host Disease | ClinicalTrials.gov |
| Interventions | Experimental ECP protocol | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mean treatment-related differences in the SF-36 scores (physical domains) collected monthly in patients in the control and experimental arms | Baseline and up to 6 months | The primary objective is to evaluate whether the proposed ECP protocol influences patient-reported QoL assessed through the Short Form-36 (SF-36) score (physical domains) | ClinicalTrials.gov |
| Secondary | cGVHD response rate (as evaluated according to the NIH criteria23) after six months of treatment in control and experimental arms | Baseline and up to 6 months | To evaluate the response rate in patients undergoing standard or experimental ECP procedures according to the NIH response criteria | ClinicalTrials.gov |
| Secondary | Mean treatment-related differences in the SF-36 scores (all domains) collected monthly in patients in the control and experimental arms | Baseline and up to 6 months | To evaluate patient-reported QoL improvement assessed through the SF-36 tool (all domains) in the standard and experimental ECP procedures | ClinicalTrials.gov |
| Secondary | Comparison of the total number of apoptotic cells infused in patients in the control and experimental arms | Baseline and up to 6 months | To assess the number of apoptotic cells infused per course in the standard and experimental ECP procedures | ClinicalTrials.gov |
| Secondary | Comparison of direct and indirect costs of ECP treatment in patients in the control and experimental arms | Through study completion, an average of 2 years | To compare the direct and indirect costs of the standard and experimental ECP procedures | ClinicalTrials.gov |
| Secondary | Rate of microbial contamination of day-2 products in the experimental arm | Through study completion, an average of 2 years | To evaluate the microbial contamination rate of day-2 products in the experimental ECP procedures | ClinicalTrials.gov |
| Secondary | Rate of adverse events at infusion in the standard and experimental arms | Through study completion, an average of 2 years | To evaluate adverse events at infusion in the standard and experimental ECP procedures | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)