Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT02520102
Status:
WITHDRAWN
Last Update Posted:
2017-04-20
First Post:
2015-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081222', 'term': 'sargramostim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Company has fulfilled post-marketing requirements', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2015-08-07', 'studyFirstSubmitQcDate': '2015-08-07', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)', 'timeFrame': '1 month after 1st dose of sargramostim'}, {'measure': 'Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)', 'timeFrame': '2 months after 1st dose of sargramostim'}, {'measure': 'Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)', 'timeFrame': '3 months after 1st dose of sargramostim'}, {'measure': 'Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)', 'timeFrame': '6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline or up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Assessment of antibodies (antibody detection and antibody titers)', 'timeFrame': '1 month after 1st dose of sargramostim'}, {'measure': 'Assessment of antibodies (antibody detection and antibody titers)', 'timeFrame': '2 months after 1st dose of sargramostim'}, {'measure': 'Assessment of antibodies (antibody detection and antibody titers)', 'timeFrame': '3 months after 1st dose of sargramostim'}, {'measure': 'Assessment of antibodies (antibody detection and antibody titers)', 'timeFrame': '6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline up to 24 months'}, {'measure': 'Assessment of immunoglobulin levels', 'timeFrame': '1 month after 1st dose of sargramostim'}, {'measure': 'Assessment of immunoglobulin levels', 'timeFrame': '2 months after 1st dose of sargramostim'}, {'measure': 'Assessment of immunoglobulin levels', 'timeFrame': '3 months after 1st dose of sargramostim'}, {'measure': 'Assessment of immunoglobulin levels', 'timeFrame': '6 months after 1st dose of sargramostim. If antibodies are positive at month 6, the level of immunoglubolins will be assesed every 6 months until the antibodies level return to baseline or up to 24 months'}, {'measure': 'Proportion of patients with adverse events', 'timeFrame': 'Up to 24 months'}, {'measure': 'Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to ≥1500/mm^3)', 'timeFrame': 'Up to 42 days after first day of sargramostim administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia NOS']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nMeasure the proportion of patients who develop binding and neutralizing antibodies in the blood after treatment with sargramostim following induction/reinduction chemotherapy.\n\nSecondary Objectives:\n\n* Assess the time after treatment at which the antibodies develop and the level of antibodies is measured after the first dose.\n* Measure the levels of immunoglobulin protein.\n* Assess the impact of any immune response on safety and the duration of low white blood cell count.', 'detailedDescription': 'The total study duration for a participant is up to 6 months from 1st dose of sargramostim or until the antibodies level return to baseline or up to 24 months if antibodies test is positive at month 6.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Able to provide informed consent.\n* Newly diagnosed acute myeloid leukemia (AML) to be treated with standard of care induction chemotherapy as per local policy.\n* Patients 55 to 70 years of age (inclusive).\n* Negative serum pregnancy test within 30 days prior to receiving the first dose of induction chemotherapy in female participants who are \\<2 years postmenopausal or who are of childbearing potential and have agreed to begin or continue using an adequate method of contraception.\n\nExclusion criteria:\n\n* Prior treatment with sargramostim or any leukocyte growth factor (LGF) product.\n* Prior myelodysplastic syndrome (MDS).\n* Known central nervous system (CNS) leukemic involvement diagnosed by cytologic findings in cerebrospinal fluid and/or by computed tomography (CT) or magnetic resonance imaging (MRI).\n* Out of range (\\>2x normal) laboratory values.\n* Clinically important medical conditions unrelated to AML as determined by the Investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\>2.\n* Bone marrow blasts ≥5% on marrow examination following induction or reinduction chemotherapy.\n* History of allergy to yeast products, recombinant human granulocyte/macrophage-colony-stimulating factor, or any component of sargramostim.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02520102', 'briefTitle': 'Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase II Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia', 'orgStudyIdInfo': {'id': 'LTS13932'}, 'secondaryIdInfos': [{'id': 'U1111-1148-1183', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sargramostim', 'description': 'Sargramostim is administered daily until the absolute neutrophil count (ANC) equals or exceeds 1500/mm\\^3 for 3 consecutive measurements or up to 42 days post-induction chemotherapy.', 'interventionNames': ['Drug: sargramostim GZ402664']}], 'interventions': [{'name': 'sargramostim GZ402664', 'type': 'DRUG', 'otherNames': ['Leukine'], 'description': 'Pharmaceutical form: lyophilized powder in vial\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['sargramostim']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}