<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03007238</url>
  </required_header>
  <id_info>
    <org_study_id>15125</org_study_id>
    <secondary_id>NCI-2015-01933</secondary_id>
    <secondary_id>15125</secondary_id>
    <nct_id>NCT03007238</nct_id>
  </id_info>
  <brief_title>Extracorporeal Photopheresis and Low Dose Aldesleukin in Treating Patients With Steroid Refractory Chronic Graft-Versus-Host Disease</brief_title>
  <official_title>Phase II Trial of Extracorporeal Photopheresis (ECP) Plus Low Dose IL-2 for Treatment of Steroid Refractory Chronic Graft-versus-Host Disease (cGVHD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin&#xD;
      (interleukin-2) in treating patients with chronic graft-versus-host disease (cGVHD) that does&#xD;
      not respond to upfront treatment with steroids. In graft-vs-host disease, patients have a&#xD;
      small quantity of a white blood cell called T regulatory cells or T-reg cells that helps to&#xD;
      control the immune system. Extracorporeal photopheresis is a procedure where patient's blood&#xD;
      is removed and treated with ultraviolet light and drugs that become active when exposed to&#xD;
      light. The treated blood is then returned to the patient and may be effective in increasing&#xD;
      T-reg cells in patients with cGVHD. Aldesleukin increases the activity and growth of white&#xD;
      blood cells, and it has shown to enhance T-reg cells in patients with cGVHD and may be&#xD;
      effective improving GVHD symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the anti-cGVHD activity of extracorporeal photopheresis (ECP) when combined&#xD;
      with low dose IL-2 (interleukin 2) (aldesleukin), in patients with steroid refractory cGVHD,&#xD;
      as assessed by overall cGVHD response rate (complete response [CR]+partial response&#xD;
      [PR]+stable disease [SD]).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Characterize and evaluate toxicities, including type, frequency, severity, attribution,&#xD;
      time course and duration.&#xD;
&#xD;
      II. Estimate overall and failure-free survival, non-relapse mortality (NRM) and relapse,&#xD;
      through 1 year after initiation of treatment.&#xD;
&#xD;
      III. Characterize chronic GVHD Symptom Scale scores -self-report (with assistance from&#xD;
      register nurses [RNs] and medical doctors [MDs]).&#xD;
&#xD;
      IV. Assess the immunologic effects of low-dose daily subcutaneous (SC) IL-2 + ECP.&#xD;
&#xD;
      V. Correlate clinical endpoints of response with ECP performance parameters.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive aldesleukin subcutaneously (SC) daily for 12 weeks. Patients also undergo&#xD;
      ECP twice weekly on weeks 1-4 and then receive 2 ECP treatments every 2 weeks on weeks 5-12.&#xD;
      Patients responding to upfront therapy with aldesleukin and ECP have the option to continue&#xD;
      combination therapy per the discretion of the treating physician until clinical benefit is&#xD;
      maintained or toxicities develop.&#xD;
&#xD;
      After completion of study treatment, patients are followed up periodically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall response (CR+ PR+SD) based on the National Institutes of Health cGVHD consensus criteria</measure>
    <time_frame>Up to 4 weeks after the end of treatment</time_frame>
    <description>The overall response rate (CR+PR) will be calculated as the percent of evaluable patients; exact 95% confidence intervals will be calculated for these estimates. Response rates will also be evaluated based on number and type of prior therapy(ies). Time to response and duration of response will be estimated using the product-limit method of Kaplan and Meier.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in immunologic function</measure>
    <time_frame>Baseline to up to 4 weeks after the end of treatment</time_frame>
    <description>The following markers will be studied at baseline , 3 week intervals and at end of study to evaluate immunological response to ECP+ IL-2 treatment.&#xD;
Effector memory cells ( CD 45RA-CCR7-/CD62-)&#xD;
Th17 cells&#xD;
Tregs ( CD4+CD25+CD127-)&#xD;
TRECS (T cell receptor excision circles)&#xD;
CD3+ Cells ( T con)17&#xD;
CD 19+( B cell marker )&#xD;
CD3-CD16+CD56+( NK cells)&#xD;
FoxP3 gene methylation status&#xD;
Inflammatory Markers:&#xD;
IFN-γ, TNF α&#xD;
IL-2,IL-4,IL-6,IL-8&#xD;
BAFF&#xD;
IL-2 receptor α (IL2R α) and hepatocyte growth factor (HGF) for systemic GVHD&#xD;
Elafin for skin GVHD&#xD;
Regenerating islet-derived 3α (REG3α) for gastrointestinal GVHD&#xD;
Suppression of tumorigenicity 2 (ST2) for steroid-refractoriness&#xD;
CXCL9&#xD;
Micro RNA analysis&#xD;
Plasma banking to be done for microRNA analysis for cGVHD&#xD;
Skin biopsy specimens will be taken at beginning and end of therapy as clinically appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic GVHD symptom score using the GVHD Symptom Scale</measure>
    <time_frame>Up to 16 weeks</time_frame>
    <description>Self-Reported symptom Scales will be obtained at baseline and weeks 3, 7, 9, 12 and 16.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECP performance parameters will be analyzed based on Median time spent for each ECP session.</measure>
    <time_frame>Up to 4 weeks after the end of treatment</time_frame>
    <description>Clinical response to therapy will be co-related with ECP performance parameters which will include median time spent on ECP machine, second versus third generation device, and flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECP performance parameters will be analyzed based on Flow rates during each ECP session.</measure>
    <time_frame>Up to 4 weeks after the end of treatment</time_frame>
    <description>Clinical response to therapy will be co-related with ECP performance parameters which will include median time spent on ECP machine, second versus third generation device, and flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECP performance parameters will be analyzed based on Outcomes based on use of second or third generation devices.</measure>
    <time_frame>Up to 4 weeks after the end of treatment</time_frame>
    <description>Clinical response to therapy will be co-related with ECP performance parameters which will include median time spent on ECP machine, second versus third generation device, and flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failure-free survival</measure>
    <time_frame>From date of first dose of study drug to first documented cGVHD progression (necessitating change of treatment), malignancy relapse or progression or death from any cause, whichever occurs first, assessed up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03</measure>
    <time_frame>Up to 4 weeks after the end of treatment</time_frame>
    <description>Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome. Baseline information (e.g. the extent/type of prior therapy) and demographic information will be presented as well to describe the patients treated in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-relapse mortality</measure>
    <time_frame>From date of first dose of study drug to death from any cause among patients without active disease, assessed up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From date of first dose of study drug to date of death from any cause, assessed up to 4 years</time_frame>
    <description>Overall survival will be estimated using the product-limit method of Kaplan and Meier.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Chronic Graft Versus Host Disease</condition>
  <arm_group>
    <arm_group_label>Supportive care (aldesleukin and ECP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive aldesleukin SC daily for 12 weeks. Patients also undergo ECP twice weekly on weeks 1-4 and then receive 2 ECP treatments every 2 weeks on weeks 5-12. Patients responding to upfront therapy with aldesleukin and ECP have the option to continue combination therapy per the discretion of the treating physician until clinical benefit is maintained or toxicities develop.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Aldesleukin</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Supportive care (aldesleukin and ECP)</arm_group_label>
    <other_name>125-L-Serine-2-133-interleukin 2</other_name>
    <other_name>Proleukin</other_name>
    <other_name>r-serHuIL-2</other_name>
    <other_name>Recombinant Human IL-2</other_name>
    <other_name>Recombinant Human Interleukin-2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Extracorporeal Photopheresis</intervention_name>
    <description>Undergo ECP</description>
    <arm_group_label>Supportive care (aldesleukin and ECP)</arm_group_label>
    <other_name>Extracorporeal Photophoresis</other_name>
    <other_name>photopheresis</other_name>
    <other_name>Photophoresis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Supportive care (aldesleukin and ECP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive care (aldesleukin and ECP)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recipients of allogeneic stem cell transplantation with myeloablative or&#xD;
             non-myeloablative conditioning regimens; alternative donor transplants (umbilical cord&#xD;
             blood and haploidentical) are allowed&#xD;
&#xD;
          -  Patients with chronic GVHD requiring systemic therapy are eligible&#xD;
&#xD;
          -  Participants must have steroid-refractory cGVHD, which is defined as having persistent&#xD;
             signs and symptoms of cGVHD despite the use of prednisone at 0.20 mg/kg/day (or 0.5&#xD;
             mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate&#xD;
             corticosteroids) without complete resolution of signs and symptoms&#xD;
&#xD;
          -  Karnofsky performance status of 70-100 %&#xD;
&#xD;
          -  Estimated life expectancy greater than 3 months&#xD;
&#xD;
          -  Women of child-bearing potential and men must agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control or abstinence) prior to study entry and&#xD;
             for six months following duration of study participation; should a woman become&#xD;
             pregnant or suspect that she is pregnant while participating on the trial, she should&#xD;
             inform her treating physician immediately&#xD;
&#xD;
          -  Stable dose of corticosteroids for 2 weeks prior to enrollment, i.e. the patient's&#xD;
             steroid dose (mg/kg) will remain unchanged (eg 0.5 mg/kg) in the 2 weeks preceding&#xD;
             enrollment; allowances will be made for up or down titrating the dose based on changes&#xD;
             in body weight&#xD;
&#xD;
          -  Total bilirubin &lt; 2.0 mg/dl-exception permitted in patients with Gilbert's syndrome&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])&#xD;
             =&lt; 2 x upper limit of normal (ULN), unless hepatic dysfunction is a manifestation of&#xD;
             presumed cGVHD&#xD;
&#xD;
          -  Abnormal liver function tests (LFTs) in the context of active cGVHD involving other&#xD;
             organ systems may also be permitted if the treating physician documents the LFTs as&#xD;
             being consistent with hepatic cGVHD and a liver biopsy will not be mandated in this&#xD;
             situation&#xD;
&#xD;
          -  Serum creatinine within normal institutional limits or creatinine clearance &gt; 60&#xD;
             mL/min/1.73 m^2 for participants with creatinine levels above institutional normal&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt; 1000/mm^3&#xD;
&#xD;
          -  Platelets &gt; 50,000/mm^3&#xD;
&#xD;
          -  All subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent&#xD;
&#xD;
          -  Patients with steroid refractory cGVHD typically have received salvage with multiple&#xD;
             lines of therapy; hence in this trial there will be no restriction in terms of prior&#xD;
             lines of therapy received; prior ECP exposure is allowed, however prior IL-2 use is&#xD;
             excluded&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients should not have any uncontrolled illness including ongoing or active&#xD;
             infection; patients with an ongoing prednisone requirement of &gt; 1 mg/kg/day (or&#xD;
             equivalent) will be excluded&#xD;
&#xD;
          -  History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic&#xD;
             thrombocytopenic purpura&#xD;
&#xD;
          -  Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment&#xD;
&#xD;
          -  Donor lymphocyte infusion within 100 days prior to enrollment&#xD;
&#xD;
          -  Active malignant relapse&#xD;
&#xD;
          -  Uncontrolled cardiac angina or symptomatic congestive heart failure (New York Heart&#xD;
             Association [NYHA] class III or IV)&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral&#xD;
             therapy are ineligible&#xD;
&#xD;
          -  Patients may not be receiving any other investigational agents, or concurrent&#xD;
             parenteral biological, chemotherapy, or radiation therapy. Oral chemotherapeutic&#xD;
             agents or biologics-for example ruxolitinib therapy (either past or current&#xD;
             exposure)-is allowed&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to IL-2&#xD;
&#xD;
          -  Patients must not have received prior chemotherapy (pentostatin) within 4 weeks before&#xD;
             study enrollment, and those who have not recovered from the adverse events due to&#xD;
             agents administered more than 4 weeks earlier are excluded&#xD;
&#xD;
          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if&#xD;
             the mother is treated with IL-2&#xD;
&#xD;
          -  Patients with other active malignancies are ineligible for this study, other than&#xD;
             superficial localized skin cancer (basal or squamous cell carcinoma)&#xD;
&#xD;
          -  Subjects, who in the opinion of the investigator may not be able to comply with IL-2&#xD;
             or ECP treatment requirements or the safety monitoring requirements of the study, will&#xD;
             be excluded from participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amandeep Salhotra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 23, 2015</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis Obliterans Syndrome</mesh_term>
    <mesh_term>Graft vs Host Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aldesleukin</mesh_term>
    <mesh_term>Interleukin-2</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03007238
org study id: 15125
secondary id: NCI-2015-01933
secondary id: 15125
nct id: NCT03007238
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin
      (interleukin-2) in treating patients with chronic graft-versus-host disease (cGVHD) that does
      not respond to upfront treatment with steroids. In graft-vs-host disease, patients have a
      small quantity of a white blood cell called T regulatory cells or T-reg cells that helps to
      control the immune system. Extracorporeal photopheresis is a procedure where patient's blood
      is removed and treated with ultraviolet light and drugs that become active when exposed to
      light. The treated blood is then returned to the patient and may be effective in increasing
      T-reg cells in patients with cGVHD. Aldesleukin increases the activity and growth of white
      blood cells, and it has shown to enhance T-reg cells in patients with cGVHD and may be
      effective improving GVHD symptoms.
PRIMARY OBJECTIVES:

      I. To evaluate the anti-cGVHD activity of extracorporeal photopheresis (ECP) when combined
      with low dose IL-2 (interleukin 2) (aldesleukin), in patients with steroid refractory cGVHD,
      as assessed by overall cGVHD response rate (complete response [CR]+partial response
      [PR]+stable disease [SD]).

      SECONDARY OBJECTIVES:

      I. Characterize and evaluate toxicities, including type, frequency, severity, attribution,
      time course and duration.

      II. Estimate overall and failure-free survival, non-relapse mortality (NRM) and relapse,
      through 1 year after initiation of treatment.

      III. Characterize chronic GVHD Symptom Scale scores -self-report (with assistance from
      register nurses [RNs] and medical doctors [MDs]).

      IV. Assess the immunologic effects of low-dose daily subcutaneous (SC) IL-2 + ECP.

      V. Correlate clinical endpoints of response with ECP performance parameters.

      OUTLINE:

      Patients receive aldesleukin subcutaneously (SC) daily for 12 weeks. Patients also undergo
      ECP twice weekly on weeks 1-4 and then receive 2 ECP treatments every 2 weeks on weeks 5-12.
      Patients responding to upfront therapy with aldesleukin and ECP have the option to continue
      combination therapy per the discretion of the treating physician until clinical benefit is
      maintained or toxicities develop.

      After completion of study treatment, patients are followed up periodically.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response (CR+ PR+SD) based on the National Institutes of Health cGVHD consensus criteria
time frame: Up to 4 weeks after the end of treatment
description: The overall response rate (CR+PR) will be calculated as the percent of evaluable patients; exact 95% confidence intervals will be calculated for these estimates. Response rates will also be evaluated based on number and type of prior therapy(ies). Time to response and duration of response will be estimated using the product-limit method of Kaplan and Meier.
measure: Change in immunologic function
time frame: Baseline to up to 4 weeks after the end of treatment
description: The following markers will be studied at baseline , 3 week intervals and at end of study to evaluate immunological response to ECP+ IL-2 treatment.
Effector memory cells ( CD 45RA-CCR7-/CD62-)
Th17 cells
Tregs ( CD4+CD25+CD127-)
TRECS (T cell receptor excision circles)
CD3+ Cells ( T con)17
CD 19+( B cell marker )
CD3-CD16+CD56+( NK cells)
FoxP3 gene methylation status
Inflammatory Markers:
IFN-γ, TNF α
IL-2,IL-4,IL-6,IL-8
BAFF
IL-2 receptor α (IL2R α) and hepatocyte growth factor (HGF) for systemic GVHD
Elafin for skin GVHD
Regenerating islet-derived 3α (REG3α) for gastrointestinal GVHD
Suppression of tumorigenicity 2 (ST2) for steroid-refractoriness
CXCL9
Micro RNA analysis
Plasma banking to be done for microRNA analysis for cGVHD
Skin biopsy specimens will be taken at beginning and end of therapy as clinically appropriate.
measure: Chronic GVHD symptom score using the GVHD Symptom Scale
time frame: Up to 16 weeks
description: Self-Reported symptom Scales will be obtained at baseline and weeks 3, 7, 9, 12 and 16.
measure: ECP performance parameters will be analyzed based on Median time spent for each ECP session.
time frame: Up to 4 weeks after the end of treatment
description: Clinical response to therapy will be co-related with ECP performance parameters which will include median time spent on ECP machine, second versus third generation device, and flow.
measure: ECP performance parameters will be analyzed based on Flow rates during each ECP session.
time frame: Up to 4 weeks after the end of treatment
description: Clinical response to therapy will be co-related with ECP performance parameters which will include median time spent on ECP machine, second versus third generation device, and flow.
measure: ECP performance parameters will be analyzed based on Outcomes based on use of second or third generation devices.
time frame: Up to 4 weeks after the end of treatment
description: Clinical response to therapy will be co-related with ECP performance parameters which will include median time spent on ECP machine, second versus third generation device, and flow.
measure: Failure-free survival
time frame: From date of first dose of study drug to first documented cGVHD progression (necessitating change of treatment), malignancy relapse or progression or death from any cause, whichever occurs first, assessed up to 4 years
measure: Incidence of adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
time frame: Up to 4 weeks after the end of treatment
description: Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome. Baseline information (e.g. the extent/type of prior therapy) and demographic information will be presented as well to describe the patients treated in this study.
measure: Non-relapse mortality
time frame: From date of first dose of study drug to death from any cause among patients without active disease, assessed up to 4 years
measure: Overall survival
time frame: From date of first dose of study drug to date of death from any cause, assessed up to 4 years
description: Overall survival will be estimated using the product-limit method of Kaplan and Meier.
arm group label: Supportive care (aldesleukin and ECP)
arm group type: Experimental
description: Patients receive aldesleukin SC daily for 12 weeks. Patients also undergo ECP twice weekly on weeks 1-4 and then receive 2 ECP treatments every 2 weeks on weeks 5-12. Patients responding to upfront therapy with aldesleukin and ECP have the option to continue combination therapy per the discretion of the treating physician until clinical benefit is maintained or toxicities develop.
intervention type: Biological
intervention name: Aldesleukin
description: Given SC
arm group label: Supportive care (aldesleukin and ECP)
other name: 125-L-Serine-2-133-interleukin 2
other name: Proleukin
other name: r-serHuIL-2
other name: Recombinant Human IL-2
other name: Recombinant Human Interleukin-2
intervention type: Procedure
intervention name: Extracorporeal Photopheresis
description: Undergo ECP
arm group label: Supportive care (aldesleukin and ECP)
other name: Extracorporeal Photophoresis
other name: photopheresis
other name: Photophoresis
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Supportive care (aldesleukin and ECP)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Supportive care (aldesleukin and ECP)
other name: Quality of Life Assessment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amandeep Salhotra, MD
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bronchiolitis Obliterans Syndrome
mesh term: Graft vs Host Disease
mesh term: Aldesleukin
mesh term: Interleukin-2