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A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02340676
Recruitment Status : Active, not recruiting
First Posted : January 19, 2015
Results First Posted : October 18, 2018
Last Update Posted : March 6, 2023
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
John Koreth, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Graft-versus-host-disease
Interventions Procedure: Extracorporeal Photopheresis (ECP)
Drug: Interleukin-2
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description
  • 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
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description
  • 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 Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
  72.0%
>=65 years
7
  28.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
62
(34 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
13
  52.0%
Male
12
  48.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
22
  88.0%
Unknown or Not Reported
3
  12.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
24
  96.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
 100.0%
Chronic Graft-versus-Host Disease (cGVHD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Mild
1
   4.0%
Moderate
19
  76.0%
Severe
5
  20.0%
1.Primary Outcome
Title Percentage of Participant With Response at Week 16
Hide Description Participants will have their cGVHD evaluated at baseline through Week 16.
Time Frame Baseline through Week 16 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
22 evaluable for efficacy
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 25
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of patients
59
(40 to 77)
2.Secondary Outcome
Title Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy
Hide Description All Grade 3 or higher toxicities related to ECP plus low-dose SC IL-2 therapy have been reported.
Time Frame Baseline through Week 16 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Occurrance of reported grade
Grade 3 5
Grade 4 0
Grade 5 0
3.Secondary Outcome
Title Regulatory T Cell Counts During ECP Plus Low-dose Daily SC IL-2
Hide Description Assays will be conducted to detect Change in Regulatory T cell counts during ECP plus low-dose daily SC IL-2
Time Frame Baseline through Week 16 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 25
Median (Inter-Quartile Range)
Unit of Measure: cells/uL
Baseline
11.7
(5.6 to 18.2)
Week 16
50.7
(32.5 to 75.4)
4.Secondary Outcome
Title Prednisone Use During ECP Plus Low-dose IL-2 From Baseline Through Week 16 of Study
Hide Description Prednisone use was assessed during ECP plus low-dose IL-2 treatment at baseline through Week 16 of study.
Time Frame Baseline through Week 16 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 25
Median (Full Range)
Unit of Measure: median percentage of change
25
(-67 to 300)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival From the start of treatment to 1 Year was assessed
Time Frame From the start of treatment to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of probability
80
(58 to 91)
6.Secondary Outcome
Title Progression-free Survival
Hide Description One year overall survival was analyzed
Time Frame From the start of treatment to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of probability
76
(54 to 88)
7.Secondary Outcome
Title Non-relapse Mortality
Hide Description Participants one year cumulative incidence of Non-relapse mortality was assessed.
Time Frame From the start of treatment to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of probability
20
(7 to 38)
8.Secondary Outcome
Title Relapse at 1 Year
Hide Description Relapse at 1 year was assessed
Time Frame From the start of treatment to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of probability
4
(0.3 to 17)
Time Frame Adverse event data was collected from initiation of study intervention, throughout the study, and within 30 days of the last study intervention.
Adverse Event Reporting Description Reporting Participating investigators assessed the occurrence of Adverse Events and Serious Adverse Events at all participant evaluation time points during the study.
 
Arm/Group Title ECP Plus IL-2
Hide Arm/Group Description
  • 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
All-Cause Mortality
ECP Plus IL-2
Affected / at Risk (%)
Total   3/25 (12.00%)    
Hide Serious Adverse Events
ECP Plus IL-2
Affected / at Risk (%) # Events
Total   3/25 (12.00%)    
Cardiac disorders   
Cardiac Arrest † 1 [1]  1/25 (4.00%)  1
Infections and infestations   
Parainfluenza Type 3 † 1 [2]  1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchiolitis Obliterans Syndrome † 1 [3]  1/25 (4.00%)  1
1
Term from vocabulary, CTEP Version 4.0
†
Indicates events were collected by systematic assessment
[1]
1 Participant passed away to Grade 5 Cardiac Arrest. Unexpected and unrelated to study treatment.
[2]
1 Participant passed away due to Grade 5 Parainfluenza Type 3. Expected and unrelated to study treatment.
[3]
1 Participant passed away to Grad5 Bronchiolitis Obliterans Syndrome. Expected and unrelated to study treatment.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ECP Plus IL-2
Affected / at Risk (%) # Events
Total   2/25 (8.00%)    
Respiratory, thoracic and mediastinal disorders   
Cough † 1 [1]  1/25 (4.00%)  1
Vascular disorders   
Acute Limb Schemia † 1 [2]  1/25 (4.00%)  1
1
Term from vocabulary, CTEP Version 4.0
†
Indicates events were collected by systematic assessment
[1]
1 Participant experienced Grade 2 Cough. Unexpected and possible to study treatment.
[2]
1 Participant experienced Grade 3 Acute Limb Ischemia. Unexpected and possible to study treatment.
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John Koreth, MBBS, DPhil
Organization: Dana-Farber Cancer Institute
Phone: (617) 632-2949
EMail: John_Koreth@dfci.harvard.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: John Koreth, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02340676    
Other Study ID Numbers: 14-479
First Submitted: January 7, 2015
First Posted: January 19, 2015
Results First Submitted: August 9, 2018
Results First Posted: October 18, 2018
Last Update Posted: March 6, 2023