Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-02 @ 4:38 AM
Study NCT ID:
NCT01366092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2011-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'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'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System 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, DPhil', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug at Week 1 until Week 16 visit.', 'description': 'Participants were evaluated for adverse events at every clinical visit during Weeks 1,2,4,6,8.10,12,16 and every 4 weeks on extended duration therapy. Only serious adverse events and other adverse events that occurred during the 16-week study period are recorded here. Per protocol, only AEs Grade 3 or higher were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Interleukin-2', 'description': 'Interleukin-2: Daily subcutaneous IL-2 (1 x 10\\^6 IU/m\\^2/day) for self-administration for 12 weeks followed by 4-week hiatus', 'otherNumAtRisk': 35, 'otherNumAffected': 10, 'seriousNumAtRisk': 35, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Platelet count decreased', 'notes': 'This event was deemed possibly related to study treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'notes': 'This event was deemed probably related to study treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flu-like symptoms', 'notes': 'This event was deemed related to study treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'notes': 'This event was deemed unrelated to study therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'notes': 'This event was deemed unrelated to study therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'notes': 'This event was deemed unrelated to study therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral Motor Neuropathy', 'notes': 'This event was deemed unrelated to study therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthralgia', 'notes': 'This event was deemed unrelated to study therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thromoembolic Event', 'notes': 'This event was deemed unrelated to study therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Hyperglycemia', 'notes': 'These events were deemed unrelated to study treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pneumothorax', 'notes': 'These events were deemed unrelated to study treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Streptococcus viridans infection', 'notes': 'This event was deemed unrelated to study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate of Low-dose Daily SC IL-2 in Steroid-refractory cGVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interleukin-2', 'description': 'Interleukin-2: Daily subcutaneous IL-2 (1 x 10\\^6 IU/m\\^2/day) for self-administration for 12 weeks followed by 4-week hiatus'}], 'classes': [{'title': 'Overall Partial Response', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Overall Stable Response', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Overall cGVHD Progression', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Skin cGVHD Response', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Joint/Fascia/Muscle cGVHD Response', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Liver cGVHD Response', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Lung cGVHD Response', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'GI tract cGVHD Response', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 6 weeks, and 12 weeks', 'description': 'Participants were evaluated according to the cGVHD NIH Consensus criteria at baseline, 6 weeks, and 12 weeks on study. Per cGVHD NIH Consensus criteria, cGVHD involved organ systems are given a grade 0-3 and an overall cGVHD score, from 0-10, is given. Complete Response is defined as resolution of all reversible manifestations in each organ or site of cGVHD. A partial response is defined as an improvement in measure at least one organ or site, or decrease in global ratings by at least a 2-point change on the 10-point scale, without progression measured at any other organ or site. Non-responders have no change in cGVHD meeting criteria for either partial response or disease progression. Progressive disease is defined as an increase in organ or site scales (1-point change on a 3-point scale) or 2- to 3-point increase on the global cGVHD ratings. Clinical worsening of cGVHD is not synonymous with progressive cGVHD per NIH criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '33 of 35 patients were evaluable for response criteria. To be evaluable, patients had to receive at least 6 weeks of daily IL-2 and had their disease re-assessed.'}, {'type': 'SECONDARY', 'title': 'Toxicity of 12-week Course of Low-dose SC IL-2 Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interleukin-2', 'description': 'Interleukin-2: Daily subcutaneous IL-2 (1 x 10\\^6 IU/m\\^2/day) for self-administration for 12 weeks followed by 4-week hiatus'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Participants were evaluated at clinical visits for toxicities related to IL-2 throughout their 12-week treatment course', 'unitOfMeasure': 'Grade 2 or higher related AEs', 'reportingStatus': 'POSTED', 'populationDescription': "Grade 2 or higher, related to IL-2, adverse events (AE) were recorded for participants during their 12-week IL-2 treatment course. AE's were evaluated based on the CTCAE version 4.0."}, {'type': 'SECONDARY', 'title': 'Prednisone Taper With IL-2 Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interleukin-2', 'description': 'Interleukin-2: Daily subcutaneous IL-2 (1 x 10\\^6 IU/m\\^2/day) for self-administration for 12 weeks followed by 4-week hiatus'}], 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of treatment after 16 weeks or most recent follow-up date for patients on extended', 'description': 'Participants had their steroid dose assessed at weeks 6, 12,16, and every 8 weeks while on extended duration IL-2 therapy.', 'unitOfMeasure': 'percent taper', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Participant's steroid taper was measured using their steroid dose at the start of therapy and their dose at the end of 16 weeks. For participants who continued on extended duration therapy, their final steroid dose was determined at the time of stopping treatment or, if still ongoing, the last clinic visit at the time of data analysis."}, {'type': 'SECONDARY', 'title': 'Overall Survival and Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interleukin-2', 'description': 'Interleukin-2: Daily subcutaneous IL-2 (1 x 10\\^6 IU/m\\^2/day) for self-administration for 12 weeks followed by 4-week hiatus'}], 'classes': [{'title': 'Overall Survival', 'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Progression-Free Survival', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years from start of IL-2', 'description': 'Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. OS was defined as from the study entry to death from any cause. Patients who were alive or lost to follow-up were censored at the time last seen alive. PFS was defined from the study entry to disease relapse or progression or death from any cause, whichever occurred first.', 'unitOfMeasure': 'probability', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunologic Effects of Low-dose Daily SC IL-2: Treg Cell Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interleukin-2', 'description': 'Interleukin-2: Daily subcutaneous IL-2 (1 x 10\\^6 IU/m\\^2/day) for self-administration for 12 weeks followed by 4-week hiatus'}], 'classes': [{'title': 'Baseline regulatory T cell', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '40.6'}]}]}, {'title': 'Week 4 Treg cell count', 'categories': [{'measurements': [{'value': '137.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '188'}]}]}, {'title': 'Week 12 Treg cell count', 'categories': [{'measurements': [{'value': '104.1', 'groupId': 'OG000', 'lowerLimit': '53.9', 'upperLimit': '167.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks of study follow-up', 'description': "Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The CD4+CD25+FOXP3+ regulatory T cells (Treg) counts were measured.", 'unitOfMeasure': 'cell count/ uL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunologic Effects of Low-dose Daily SC IL-2: Treg/Tcon Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interleukin-2', 'description': 'Interleukin-2: Daily subcutaneous IL-2 (1 x 10\\^6 IU/m\\^2/day) for self-administration for 12 weeks followed by 4-week hiatus'}], 'classes': [{'title': 'Baseline Treg:Tcon ratio', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.13'}]}]}, {'title': 'Week 2 Treg:Tcon ratio', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.48'}]}]}, {'title': 'Week 12 Treg:Tcon ratio', 'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '0.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks of study follow-up', 'description': "Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The ratio between CD4+CD25+FOXP3+ regulatory T cells (Treg) and CD4 conventional T cell (Tcon) counts were measured.", 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interleukin-2', 'description': 'Interleukin-2: Daily subcutaneous IL-2 (1 x 10\\^6 IU/m\\^2/day) for self-administration for 12 weeks followed by 4-week hiatus'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Progressive cGVHD', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Interleukin-2', 'description': 'Interleukin-2: Daily subcutaneous IL-2 (1 x 10\\^6 IU/m\\^2/day) for self-administration for 12 weeks followed by 4-week hiatus'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time from Allogeneic Stem Cell Transplant', 'classes': [{'categories': [{'measurements': [{'value': '616', 'groupId': 'BG000', 'lowerLimit': '270', 'upperLimit': '2145'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from chronic GVHD onsent', 'classes': [{'categories': [{'measurements': [{'value': '252', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '1880'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of cGVHD organ sites', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'organs affected by cGVHD', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of concurrent cGVHD therapies', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'therapies', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline Corticosteroid (Prednisone) dose', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000', 'lowerLimit': '2.5', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'milligrams per day', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2011-06-02', 'resultsFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-07', 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate of Low-dose Daily SC IL-2 in Steroid-refractory cGVHD', 'timeFrame': 'Baseline, 6 weeks, and 12 weeks', 'description': 'Participants were evaluated according to the cGVHD NIH Consensus criteria at baseline, 6 weeks, and 12 weeks on study. Per cGVHD NIH Consensus criteria, cGVHD involved organ systems are given a grade 0-3 and an overall cGVHD score, from 0-10, is given. Complete Response is defined as resolution of all reversible manifestations in each organ or site of cGVHD. A partial response is defined as an improvement in measure at least one organ or site, or decrease in global ratings by at least a 2-point change on the 10-point scale, without progression measured at any other organ or site. Non-responders have no change in cGVHD meeting criteria for either partial response or disease progression. Progressive disease is defined as an increase in organ or site scales (1-point change on a 3-point scale) or 2- to 3-point increase on the global cGVHD ratings. Clinical worsening of cGVHD is not synonymous with progressive cGVHD per NIH criteria.'}], 'secondaryOutcomes': [{'measure': 'Toxicity of 12-week Course of Low-dose SC IL-2 Therapy', 'timeFrame': '12 weeks', 'description': 'Participants were evaluated at clinical visits for toxicities related to IL-2 throughout their 12-week treatment course'}, {'measure': 'Prednisone Taper With IL-2 Therapy', 'timeFrame': 'End of treatment after 16 weeks or most recent follow-up date for patients on extended', 'description': 'Participants had their steroid dose assessed at weeks 6, 12,16, and every 8 weeks while on extended duration IL-2 therapy.'}, {'measure': 'Overall Survival and Progression-free Survival', 'timeFrame': '2 years from start of IL-2', 'description': 'Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. OS was defined as from the study entry to death from any cause. Patients who were alive or lost to follow-up were censored at the time last seen alive. PFS was defined from the study entry to disease relapse or progression or death from any cause, whichever occurred first.'}, {'measure': 'Immunologic Effects of Low-dose Daily SC IL-2: Treg Cell Counts', 'timeFrame': '16 weeks of study follow-up', 'description': "Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The CD4+CD25+FOXP3+ regulatory T cells (Treg) counts were measured."}, {'measure': 'Immunologic Effects of Low-dose Daily SC IL-2: Treg/Tcon Ratio', 'timeFrame': '16 weeks of study follow-up', 'description': "Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The ratio between CD4+CD25+FOXP3+ regulatory T cells (Treg) and CD4 conventional T cell (Tcon) counts were measured."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stem cell transplant', 'GVHD', 'bone marrow transplant', 'cord blood transplant', 'regulatory T cell', 'interleukin'], 'conditions': ['Chronic Graft-versus-host Disease']}, 'descriptionModule': {'briefSummary': "Chronic GVHD is a medical condition that may occur after a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize the your body (the host) as foreign and attempt to 'reject' it. This process is known as graft-versus-host-disease. It is thought that IL-2 may help control chronic GVHD by stopping the donor's immune system from 'rejecting' your body. In this research study, we are looking to see how IL-2 can be used in combination with steroids to treat cGVHD.", 'detailedDescription': 'You will give yourself or be given IL-2 daily through an injection under your skin. You should rotate the injection site, if possible. You will do this once every day for 12 weeks. You will then have 4 weeks off of IL-2. During the first 6 weeks of IL-2, you will continue to take steroids without changing the dose your doctor has set for you while you are on IL-2. After 6 weeks of IL-2 therapy, your doctor may reduce the amount of steroids you take.\n\nWhile you are on study, a member of the study team will examine you to evaluate your cGVHD. These assessments may include examination of your skin, joints/muscles, eyes, mouth, lungs and gastrointestinal system.\n\nYou will have clinic visits for evaluation of toxicity and clinical benefit approximately every 4 weeks. You will also have immunologic assays approximately every 8 weeks. Immunologic assays will measure the effect of IL-2 on immune cells.\n\nYou will be on the study for about 16 weeks. You may continue on study treatment for longer if you experience a clinical benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipient of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens\n* Steroid refractory cGVHD with systemic therapy onset within the prior 6 months\n* No more than 2 prior lines of cGVHD therapy\n* Estimated life expectancy \\> 3 months\n* Adequate organ function\n\nExclusion Criteria:\n\n* Ongoing prednisone requirement \\> 1 mg/kg/day (or equivalent)\n* Concurrent use of calcineurin-inhibitors plus sirolimus\n* History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura\n* Active malignant relapse\n* Active uncontrolled infection\n* Uncontrolled cardiac angina or symptomatic congestive heart failure\n* Organ transplant (allograft) recipient\n* HIV-positive on combination antiretroviral therapy\n* Active hepatitis B or C\n* Pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT01366092', 'briefTitle': 'Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Phase II Trial of Daily Low-Dose Interleukin-2 (IL-2) for Steroid-Refractory Chronic Graft-Versus-Host-Disease', 'orgStudyIdInfo': {'id': '11-149'}, 'secondaryIdInfos': [{'id': 'P01CA142106', 'link': 'https://reporter.nih.gov/quickSearch/P01CA142106', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interleukin-2', 'description': 'Each study participant will receive daily subcutaneous IL-2 (1 x 106 IU/m2/day) for self-administration for 12 weeks, followed by a 4-week hiatus. IL-2 will be typically administered on an outpatient basis. After completing the 16 week study (12 weeks of IL-2 study treatment and a mandatory 4 weeks off-IL-2), patients experiencing clinical benefit (complete or partial response; as well as minor response not meeting NIH criteria for partial response) with an acceptable toxicity profile will be permitted to continue extended-duration treatment indefinitely at the discretion of the treating physician.', 'interventionNames': ['Drug: Interleukin-2']}], 'interventions': [{'name': 'Interleukin-2', 'type': 'DRUG', 'otherNames': ['IL-2'], 'description': 'Daily subcutaneous IL-2 (1 x 10\\^6 IU/m\\^2/day) for self-administration for 12 weeks followed by 4-week hiatus', 'armGroupLabels': ['Interleukin-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02214', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02214', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'John Koreth, MBBS, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Prometheus Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'John Koreth, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}