Trial · NCT02340676
A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD
NCT02340676, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2018-10-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD. Trials, record NCT02340676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02340676
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD
- NCT number
- NCT02340676
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Chronic Graft-versus-host-disease
- Interventions
- Extracorporeal Photopheresis (ECP), Interleukin-2
- First posted
- 2015-01-19
- Last updated
- 2026-02-20
- Results first posted
- 2018-10-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participant With Response at Week 16 | Baseline through Week 16 of the study | Participants will have their cGVHD evaluated at baseline through Week 16. |
| Secondary | Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy | Baseline through Week 16 of the study | All Grade 3 or higher toxicities related to ECP plus low-dose SC IL-2 therapy have been reported. |
| Secondary | Regulatory T Cell Counts During ECP Plus Low-dose Daily SC IL-2 | Baseline through Week 16 of the study | Assays will be conducted to detect Change in Regulatory T cell counts during ECP plus low-dose daily SC IL-2 |
| Secondary | Prednisone Use During ECP Plus Low-dose IL-2 From Baseline Through Week 16 of Study | Baseline through Week 16 of the study | Prednisone use was assessed during ECP plus low-dose IL-2 treatment at baseline through Week 16 of study. |
| Secondary | Overall Survival | From the start of treatment to 1 Year | Overall survival From the start of treatment to 1 Year was assessed |
| Secondary | Progression-free Survival | From the start of treatment to 1 Year | One year overall survival was analyzed |
| Secondary | Non-relapse Mortality | From the start of treatment to 1 Year | Participants one year cumulative incidence of Non-relapse mortality was assessed. |
| Secondary | Relapse at 1 Year | From the start of treatment to 1 Year | Relapse at 1 year was assessed |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participant With Response at Week 16 | Baseline through Week 16 of the study | 22 evaluable for efficacy | percentage of patients | NUMBER |
| SECONDARY | Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy | Baseline through Week 16 of the study | Occurrance of reported grade | NUMBER | |
| SECONDARY | Regulatory T Cell Counts During ECP Plus Low-dose Daily SC IL-2 | Baseline through Week 16 of the study | cells/uL | MEDIAN | |
| SECONDARY | Prednisone Use During ECP Plus Low-dose IL-2 From Baseline Through Week 16 of Study | Baseline through Week 16 of the study | median percentage of change | MEDIAN | |
| SECONDARY | Overall Survival | From the start of treatment to 1 Year | percentage of probability | NUMBER | |
| SECONDARY | Progression-free Survival | From the start of treatment to 1 Year | percentage of probability | NUMBER | |
| SECONDARY | Non-relapse Mortality | From the start of treatment to 1 Year | percentage of probability | NUMBER | |
| SECONDARY | Relapse at 1 Year | From the start of treatment to 1 Year | percentage of probability | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participant With Response at Week 16 | ECP Plus IL-2 | 59 | 90% Confidence Interval 40 to 77 | percentage of patients | |
| Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy | ECP Plus IL-2 | Grade 3 | 5 | Occurrance of reported grade | |
| Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy | ECP Plus IL-2 | Grade 4 | 0 | Occurrance of reported grade | |
| Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy | ECP Plus IL-2 | Grade 5 | 0 | Occurrance of reported grade | |
| Regulatory T Cell Counts During ECP Plus Low-dose Daily SC IL-2 | ECP Plus IL-2 | Baseline | 11.7 | Inter-Quartile Range 5.6 to 18.2 | cells/uL |
| Regulatory T Cell Counts During ECP Plus Low-dose Daily SC IL-2 | ECP Plus IL-2 | Week 16 | 50.7 | Inter-Quartile Range 32.5 to 75.4 | cells/uL |
| Prednisone Use During ECP Plus Low-dose IL-2 From Baseline Through Week 16 of Study | ECP Plus IL-2 | 25 | Full Range -67 to 300 | median percentage of change | |
| Overall Survival | ECP Plus IL-2 | 80 | 95% Confidence Interval 58 to 91 | percentage of probability | |
| Progression-free Survival | ECP Plus IL-2 | 76 | 95% Confidence Interval 54 to 88 | percentage of probability | |
| Non-relapse Mortality | ECP Plus IL-2 | 20 | 95% Confidence Interval 7 to 38 | percentage of probability |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ECP Plus IL-2 | 25 | |
| Overall Study | COMPLETED | ECP Plus IL-2 | 25 | |
| Overall Study | NOT COMPLETED | ECP Plus IL-2 | 0 |
Source ClinicalTrials.gov
Adverse events5
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 |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | ECP Plus IL-2 | 1 | 25 | 1 |
| other | Acute Limb Schemia | Vascular disorders | ECP Plus IL-2 | 1 | 25 | 1 |
| serious | Bronchiolitis Obliterans Syndrome | Respiratory, thoracic and mediastinal disorders | ECP Plus IL-2 | 1 | 25 | 1 |
| serious | Parainfluenza Type 3 | Infections and infestations | ECP Plus IL-2 | 1 | 25 | 1 |
| serious | Cardiac Arrest | Cardiac disorders | ECP Plus IL-2 | 1 | 25 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ECP Plus IL-2 | 3 | 25 |
| Total, other adverse events | ECP Plus IL-2 | 2 | 25 |
| Total, serious adverse events | ECP Plus IL-2 | 3 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30936057 | DERIVED |
Source PubMed
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/NCT02340676
GET https://conductscience.org/api/trials/v1/NCT02340676/registered