Trial Outcomes & Findings for A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD (NCT NCT02340676)
NCT ID: NCT02340676
Last Updated: 2026-02-20
Results Overview
Participants will have their cGVHD evaluated at baseline through Week 16.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline through Week 16 of the study
Results posted on
2026-02-20
Participant Flow
Participant milestones
| Measure |
ECP Plus IL-2
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD
Baseline characteristics by cohort
| Measure |
ECP Plus IL-2
n=25 Participants
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=14 Participants
|
|
Age, Continuous
|
62 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=14 Participants
|
|
Chronic Graft-versus-Host Disease (cGVHD)
Mild
|
1 Participants
n=14 Participants
|
|
Chronic Graft-versus-Host Disease (cGVHD)
Moderate
|
19 Participants
n=14 Participants
|
|
Chronic Graft-versus-Host Disease (cGVHD)
Severe
|
5 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 16 of the studyPopulation: 22 evaluable for efficacy
Participants will have their cGVHD evaluated at baseline through Week 16.
Outcome measures
| Measure |
ECP Plus IL-2
n=25 Participants
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Percentage of Participant With Response at Week 16
|
59 percentage of patients
Interval 40.0 to 77.0
|
SECONDARY outcome
Timeframe: Baseline through Week 16 of the studyAll Grade 3 or higher toxicities related to ECP plus low-dose SC IL-2 therapy have been reported.
Outcome measures
| Measure |
ECP Plus IL-2
n=25 Participants
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy
Grade 3
|
5 Occurrance of reported grade
|
|
Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy
Grade 4
|
0 Occurrance of reported grade
|
|
Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy
Grade 5
|
0 Occurrance of reported grade
|
SECONDARY outcome
Timeframe: Baseline through Week 16 of the studyAssays will be conducted to detect Change in Regulatory T cell counts during ECP plus low-dose daily SC IL-2
Outcome measures
| Measure |
ECP Plus IL-2
n=25 Participants
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Regulatory T Cell Counts During ECP Plus Low-dose Daily SC IL-2
Baseline
|
11.7 cells/uL
Interval 5.6 to 18.2
|
|
Regulatory T Cell Counts During ECP Plus Low-dose Daily SC IL-2
Week 16
|
50.7 cells/uL
Interval 32.5 to 75.4
|
SECONDARY outcome
Timeframe: Baseline through Week 16 of the studyPrednisone use was assessed during ECP plus low-dose IL-2 treatment at baseline through Week 16 of study.
Outcome measures
| Measure |
ECP Plus IL-2
n=25 Participants
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Prednisone Use During ECP Plus Low-dose IL-2 From Baseline Through Week 16 of Study
|
25 median percentage of change
Interval -67.0 to 300.0
|
SECONDARY outcome
Timeframe: From the start of treatment to 1 YearOverall survival From the start of treatment to 1 Year was assessed
Outcome measures
| Measure |
ECP Plus IL-2
n=25 Participants
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Overall Survival
|
80 percentage of probability
Interval 58.0 to 91.0
|
SECONDARY outcome
Timeframe: From the start of treatment to 1 YearOne year overall survival was analyzed
Outcome measures
| Measure |
ECP Plus IL-2
n=25 Participants
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Progression-free Survival
|
76 percentage of probability
Interval 54.0 to 88.0
|
SECONDARY outcome
Timeframe: From the start of treatment to 1 YearParticipants one year cumulative incidence of Non-relapse mortality was assessed.
Outcome measures
| Measure |
ECP Plus IL-2
n=25 Participants
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Non-relapse Mortality
|
20 percentage of probability
Interval 7.0 to 38.0
|
SECONDARY outcome
Timeframe: From the start of treatment to 1 YearRelapse at 1 year was assessed
Outcome measures
| Measure |
ECP Plus IL-2
n=25 Participants
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Relapse at 1 Year
|
4 percentage of probability
Interval 0.3 to 17.0
|
Adverse Events
ECP Plus IL-2
Serious events: 3 serious events
Other events: 2 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
ECP Plus IL-2
n=25 participants at risk
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis Obliterans Syndrome
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected from initiation of study intervention, throughout the study, and within 30 days of the last study intervention.
Reporting Participating investigators assessed the occurrence of Adverse Events and Serious Adverse Events at all participant evaluation time points during the study.
|
|
Infections and infestations
Parainfluenza Type 3
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected from initiation of study intervention, throughout the study, and within 30 days of the last study intervention.
Reporting Participating investigators assessed the occurrence of Adverse Events and Serious Adverse Events at all participant evaluation time points during the study.
|
|
Cardiac disorders
Cardiac Arrest
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected from initiation of study intervention, throughout the study, and within 30 days of the last study intervention.
Reporting Participating investigators assessed the occurrence of Adverse Events and Serious Adverse Events at all participant evaluation time points during the study.
|
Other adverse events
| Measure |
ECP Plus IL-2
n=25 participants at risk
* Extracorporeal Photopheresis (ECP) standard-of-care
* Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle
Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks
Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected from initiation of study intervention, throughout the study, and within 30 days of the last study intervention.
Reporting Participating investigators assessed the occurrence of Adverse Events and Serious Adverse Events at all participant evaluation time points during the study.
|
|
Vascular disorders
Acute Limb Schemia
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected from initiation of study intervention, throughout the study, and within 30 days of the last study intervention.
Reporting Participating investigators assessed the occurrence of Adverse Events and Serious Adverse Events at all participant evaluation time points during the study.
|
Additional Information
Dr. John Koreth, MBBS, DPhil
Dana-Farber Cancer Institute
Phone: (617) 632-2949
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place