Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT00529035
Status:
COMPLETED
Last Update Posted:
2020-07-01
First Post:
2007-09-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jkoreth@partners.org', 'phone': '(617) 632-2949', 'title': 'John Koreth, MBBS, D.Phil', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks. For patients who continued on extended-duration therapy, adverse events were reported as long as they received treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Ultra-low Dose Interleukin-2', 'description': 'Interleukin-2 (IL-2) will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels:\n\nDose Level -A 0.3 x 106 (IU/m2/d) Dose Level -B 1 x 106 (IU/m2/d) Dose Level-C 3 x 106 (IU/m2/d)', 'otherNumAtRisk': 29, 'otherNumAffected': 4, 'seriousNumAtRisk': 29, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Constitutional symptoms', 'notes': '2 subjects had low-grade constitutional symptoms (fever, malaise, arthralgia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal dysfunction (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Thrombotic microangiopathy with renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MRSA Pneumonia', 'notes': 'Subject with MRSA pneumonia documented prior to start of study treatment had recrudescent MRSA pneumonia at week 7.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MRSA furuncle', 'notes': 'MRSA furuncle preceded start of study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemophilius influenza type B bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'notes': 'On subject experienced a fatal acute myocardial infarction 70 days after coming off-treatment (unrelated to study treatment). Another subject, with known coronary artery disease, had a myocardial infarction at 2 weeks off-treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site induration', 'notes': '2 subjects experienced reversible injection site induration reactions.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Maximum Tolerated Dose and Toxicity Profile of an 8 Week Course of IL-2 in Patients With cGVHD and an Inadequate Response to Steroids.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultra-low Dose IL-2 MTD'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy', 'description': 'Three dose levels were evaluated to determine the maximally tolerated dose (MTD):\n\nDose level A: 0.3 x 10\\^6 IU/m\\^2/day Dose level B: 1.0 x 10\\^6 IU/m\\^2/day Dose level C: 3.0 x 10\\^6 IU/m\\^2/day Once the MTD (dose level B) was established, an additional 10 participants were enrolled at this dose.', 'unitOfMeasure': 'million IU/m2/day', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant terminated therapy early and was not evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Tolerated at Least 6 Weeks of Subcutaneous Low Dose IL-2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultra-low Dose Interleukin-2'}], 'classes': [{'title': 'Feasibility', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Efficacy', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy. cGVHD was assessed at Weeks 8 and 12', 'description': 'Feasibility: the number of participants who tolerated at least 6 weeks of therapy, and were thus evaluable for response. Efficacy: chronic GVHD response per NIH consensus criteria in evaluable patients.\n\nA complete response was defined as resolution of all reversible chronic GVHD-associated manifestations, a partial response as an improvement of 50% or more on the organ-specific chronic GVHD scale without progression at other organs or sites, progressive disease as an increase of 25% or more on the organ specific chronic GVHD scale, and stable disease as an improvement of less than 50% or increase of less than 25%. Please refer to the Supplementary Appendix in our published report (Koreth et al, NEJM 2011) for further details.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were evaluable for response and considered meeting the feasibility endpoint if they completed at least 6 weeks of treatment. Participants who had a partial response or complete response in cGVHD to treatment were considered to meet the efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'CD3+T, CD4+T (Including Regulatory CD4+T Cells (Treg) and Conventional CD4+T Cells (Tcon)), CD8+T, NK, NKT and B Cell Counts.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Median Absolute Cell Counts at Baseline', 'description': 'Immune-cell counts before the start of IL-2 therapy'}, {'id': 'OG001', 'title': 'Median Absolute Cell Counts at Week 8', 'description': 'Immune-cell counts after 8 weeks of IL-2 therapy'}, {'id': 'OG002', 'title': 'Median Absolute Cell Count at Week 12', 'description': 'Immune-cell counts after a 4 weeks off IL-2 per protocol'}], 'classes': [{'title': 'Treg cell count', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '35'}, {'value': '101', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '236'}, {'value': '32', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '92'}]}]}, {'title': 'Tcon cell count', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000', 'lowerLimit': '131', 'upperLimit': '412'}, {'value': '270', 'groupId': 'OG001', 'lowerLimit': '110', 'upperLimit': '678'}, {'value': '209', 'groupId': 'OG002', 'lowerLimit': '153', 'upperLimit': '550'}]}]}, {'title': 'CD8+ T cell count', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '419'}, {'value': '202', 'groupId': 'OG001', 'lowerLimit': '74', 'upperLimit': '418'}, {'value': '187', 'groupId': 'OG002', 'lowerLimit': '55', 'upperLimit': '502'}]}]}, {'title': 'Natural Killer (NK) cell count', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '250'}, {'value': '362', 'groupId': 'OG001', 'lowerLimit': '170', 'upperLimit': '570'}, {'value': '203', 'groupId': 'OG002', 'lowerLimit': '132', 'upperLimit': '311'}]}]}, {'title': 'NKT cell count', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '46'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '53'}, {'value': '22', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immunological samples taken at study appointments during the 12 week protocol schedule', 'description': 'Changes in the above immune cell populations (CD3+T, CD4+T (including CD4+Treg and CD4+Tcon), CD8+T, NK, NKT and B cell counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.\n\nAll study participants (n=28) with a sample available were reported in the data table.\n\nImmune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011).', 'unitOfMeasure': 'cells/cubic millimeter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were evaluated for regulatory T cell (Treg) expansion and other immune-cell changes while on low-dose IL-2 therapy. Participants had blood samples drawn at study appointments during the 12 week protocol schedule. Please note that for NK and NKT cell counts, only 18 participants samples were analyzed.'}, {'type': 'SECONDARY', 'title': 'Treg Cell:Tcon Cell Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Median Treg:Tcon Ratio at Baseline', 'description': 'Immune-cell ratio before the start of IL-2 therapy'}, {'id': 'OG001', 'title': 'Median Treg:Tcon Ratio at Week 8', 'description': 'Immune-cell ratio after 8 weeks of IL-2 therapy'}, {'id': 'OG002', 'title': 'Median Treg:Tcon Ratio at Week 12', 'description': 'Immune-cell ratio after a 4 weeks off IL-2 per protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.12'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.71'}, {'value': '0.14', 'groupId': 'OG002', 'lowerLimit': '0.09', 'upperLimit': '0.22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immunological samples taken at study appointments during the 12 week protocol schedule', 'description': 'Changes in the ratio of the CD4+ regulatory T cell (Treg) and CD4+ conventional T cell (Tcon) counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.\n\nAll study participants (n=28) with a sample available were reported in the data table.\n\nImmune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were evaluated for changes to the ratio of regulatory T cell (Treg) and conventional T cell (Tcon) counts while on IL-2 therapy. Participants had blood samples drawn at study appointments during the 12 week protocol schedule to analyze the immunological effects of low-dose IL-2 therapy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ultra-low Dose Interleukin-2', 'description': 'Daily subcutaneous administration of Interleukin-2 evaluated at three dose levels:\n\nDose level A: 0.3 x 10\\^6 IU/m\\^2/day Dose level B: 1.0 x 10\\^6 IU/m\\^2/day Dose level C: 3.0 x 10\\^6 IU/M\\^2/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '29 enrolled', 'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '28 evaluable, 1 patient withdrew participation and was not evaluable', 'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Interleukin-2 (IL-2) will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels:\n\nDose Level -A 0.3 x 106 (IU/m2/d) Dose Level -B 1 x 106 (IU/m2/d) Dose Level-C 3 x 106 (IU/m2/d)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'spread': '12.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-22', 'studyFirstSubmitDate': '2007-09-11', 'resultsFirstSubmitDate': '2012-08-09', 'studyFirstSubmitQcDate': '2007-09-11', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-11', 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Maximum Tolerated Dose and Toxicity Profile of an 8 Week Course of IL-2 in Patients With cGVHD and an Inadequate Response to Steroids.', 'timeFrame': 'Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy', 'description': 'Three dose levels were evaluated to determine the maximally tolerated dose (MTD):\n\nDose level A: 0.3 x 10\\^6 IU/m\\^2/day Dose level B: 1.0 x 10\\^6 IU/m\\^2/day Dose level C: 3.0 x 10\\^6 IU/m\\^2/day Once the MTD (dose level B) was established, an additional 10 participants were enrolled at this dose.'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants Who Tolerated at Least 6 Weeks of Subcutaneous Low Dose IL-2.', 'timeFrame': 'Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy. cGVHD was assessed at Weeks 8 and 12', 'description': 'Feasibility: the number of participants who tolerated at least 6 weeks of therapy, and were thus evaluable for response. Efficacy: chronic GVHD response per NIH consensus criteria in evaluable patients.\n\nA complete response was defined as resolution of all reversible chronic GVHD-associated manifestations, a partial response as an improvement of 50% or more on the organ-specific chronic GVHD scale without progression at other organs or sites, progressive disease as an increase of 25% or more on the organ specific chronic GVHD scale, and stable disease as an improvement of less than 50% or increase of less than 25%. Please refer to the Supplementary Appendix in our published report (Koreth et al, NEJM 2011) for further details.'}, {'measure': 'CD3+T, CD4+T (Including Regulatory CD4+T Cells (Treg) and Conventional CD4+T Cells (Tcon)), CD8+T, NK, NKT and B Cell Counts.', 'timeFrame': 'Immunological samples taken at study appointments during the 12 week protocol schedule', 'description': 'Changes in the above immune cell populations (CD3+T, CD4+T (including CD4+Treg and CD4+Tcon), CD8+T, NK, NKT and B cell counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.\n\nAll study participants (n=28) with a sample available were reported in the data table.\n\nImmune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011).'}, {'measure': 'Treg Cell:Tcon Cell Ratio', 'timeFrame': 'Immunological samples taken at study appointments during the 12 week protocol schedule', 'description': 'Changes in the ratio of the CD4+ regulatory T cell (Treg) and CD4+ conventional T cell (Tcon) counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.\n\nAll study participants (n=28) with a sample available were reported in the data table.\n\nImmune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic GVHD', 'Steroid refractory GVHD', 'allogeneic stem cell transplantation'], 'conditions': ['Graft Versus Host Disease']}, 'referencesModule': {'references': [{'pmid': '22129252', 'type': 'RESULT', 'citation': 'Koreth J, Matsuoka K, Kim HT, McDonough SM, Bindra B, Alyea EP 3rd, Armand P, Cutler C, Ho VT, Treister NS, Bienfang DC, Prasad S, Tzachanis D, Joyce RM, Avigan DE, Antin JH, Ritz J, Soiffer RJ. Interleukin-2 and regulatory T cells in graft-versus-host disease. N Engl J Med. 2011 Dec 1;365(22):2055-66. doi: 10.1056/NEJMoa1108188.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine the safety of IL-2 and the highest dose of this drug that can be given safely to people with chronic graft versus host disease (GVHD). Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem cell or cord blood transplant. The donor\'s immune system may recognize their body (the host) as foreign and attempt to "reject" it. Traditional standard therapy to treat chronic GVHD is prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to control chronic GVHD.', 'detailedDescription': '* IL-2 will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels.\n* Participants will be seen periodically while they are receiving IL-2. Physical exams and blood tests will be performed weekly for the first two weeks and then every other week until week 8.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipients of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens\n* Patients must be at least 180 days from the allogeneic stem cell transplantation procedure\n* Steroid refractory cGVHD, defined as having persistent symptoms and signs of GVHD despite the use of prednisone for at least 4 weeks in the preceding 12 months without complete resolution of signs and symptoms.\n* Stable dose of corticosteroids for 4 weeks prior to enrollment\n* No addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment.\n* Adequate bone marrow, renal and hepatic function as outlined in the protocol\n* 18 years of age or older\n* ECOG Performance Status of 0-2\n\nExclusion Criteria:\n\n* Ongoing prednisone requirement \\> 1mg/kg/day (or equivalent)\n* Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment\n* Concurrent ECP therapy within 4 weeks prior to enrollment\n* Post-transplant exposure to any novel immunosuppressive medication within 100 days prior to enrollment\n* Donor lymphocyte infusion within 100 days prior to IL-2 therapy\n* Active malignant disease relapse\n* Active, uncontrolled infection\n* Positive serologic test for Hepatitis B or a positive serologic or nucleic acid test for Hepatitis C\n* HIV seropositivity\n* Life expectancy \\< 3 months\n* Pregnancy or lactation\n* Inability to comply with IL-2 treatment regimen\n* Uncontrolled cardiac angina or symptomatic congestive heart failure\n* Organ transplant (allograft) recipient'}, 'identificationModule': {'nctId': 'NCT00529035', 'briefTitle': 'Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Phase I Study of Ultra-Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease', 'orgStudyIdInfo': {'id': '07-083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interleukin-2', 'description': 'Interleukin-2 (IL-2) will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels:\n\nDose Level -A 0.3 x 106 (IU/m2/d) Dose Level -B 1 x 106 (IU/m2/d) Dose Level-C 3 x 106 (IU/m2/d)', 'interventionNames': ['Drug: Interleukin-2']}], 'interventions': [{'name': 'Interleukin-2', 'type': 'DRUG', 'otherNames': ['IL-2'], 'description': 'Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.', 'armGroupLabels': ['Interleukin-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'John Koreth, MBBS, D.Phil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'John Koreth, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}