Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-10 @ 9:38 AM
Study NCT ID:
NCT01819558
Status:
COMPLETED
Last Update Posted:
2015-03-20
First Post:
2013-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], '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'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016233', 'term': 'Immunotherapy, Active'}], 'ancestors': [{'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2013-03-19', 'studyFirstSubmitQcDate': '2013-03-22', 'lastUpdatePostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety', 'timeFrame': '30 days', 'description': 'Dose limit toxicity (adverse event according to CTCAE V4.0)'}], 'secondaryOutcomes': [{'measure': 'immune response', 'timeFrame': 'up to 60 weeks after treatment', 'description': 'The specific WT1 antibody induced by the vaccination will be evaluated by the technic ELISA in UE/ml.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute myeloid leukemia', 'chronic myeloid leukemia', 'myelodysplastic syndrome', 'allograft', 'WT1 expression'], 'conditions': ['Acute Myeloid Leukemia', 'Chronic Myeloid Leukemia', 'Myelodysplastic Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.institutpaolicalmettes.fr/', 'label': 'official web site of the sponsor'}]}, 'descriptionModule': {'briefSummary': 'Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.\n\nIf WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft.\n\n6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.\n\nThe safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients older than 18 and younger than 65 years.\n2. Karnofsky ≥ 70 %.\n3. Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, who underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.\n4. Patients in morphologic complete remission at the time of transplantation.\n5. WT1 expression detectable on tumor cells.\n6. Expected life duration more than 6 months.\n7. Creatinine clearance ≥ 50 ml/min\n8. Bilirubinemia \\< 1.5N and ASAT \\< 2.5N.\n9. Women of childbearing age: negative pregnancy test and effective contraception for at least 30 days before vaccinal immunotherapy (the same contraceptive method must be continued at least 2 months after the last vaccine infusion).\n10. Membership of a social security scheme or beneficiary of such a regime.\n11. Signed inform consent.\n\nExclusion Criteria:\n\n1. Patients with severe and uncontrolled affections, especially active graft-versus-host disease requiring steroid treatment (\\>0.3 mg/kg/j) and/or Mycophenolate mofetil.\n2. Pregnant or lactating women.\n3. HIV seropositive patients.\n4. Autoimmune disease (Lupus, multiple sclerosis, Chron disease…)\n5. Previous history of allergic state which could be potentially compound by a component of the vaccinal immunotherapy.\n6. Patients who received (or are planned to receive) another experimental treatment within 30 days following the first infusion of the experimental drug of this protocol.\n7. Previous history of another cancer, except if considered as probably cured by the investigator.\n8. Patients deprived of liberty, or under guardianship.'}, 'identificationModule': {'nctId': 'NCT01819558', 'acronym': 'ALLO-WT1', 'briefTitle': 'Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': "Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches", 'orgStudyIdInfo': {'id': 'ALLO-WT1/IPC 2011-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immune therapy', 'description': '6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11.', 'interventionNames': ['Biological: recwt1-A10+AS01B']}], 'interventions': [{'name': 'recwt1-A10+AS01B', 'type': 'BIOLOGICAL', 'otherNames': ['immune therapy'], 'armGroupLabels': ['immune therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Didier BLAISE, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}