Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-27 @ 1:29 AM
Study NCT ID:
NCT01393366
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2011-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2011-07-05', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of RDI', 'timeFrame': '3 years', 'description': 'Reductions in Relative Dose Intensity, calculated as the difference between initially planned doses of F, C and R and effectively prescribed doses of the 3 drugs, before and after 6 courses of FCR.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Toxicity grade III-IV', 'timeFrame': '3 years', 'description': 'rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '30778715', 'type': 'RESULT', 'citation': 'Ysebaert L, Larcher M, Compaci G, Oberic L, Sahnes L, Banos A, Araujo C, Sommet A, Laurent G, Despas F. Oncology nurse phone calls halve the risk of reduced dose intensity of immunochemotherapy: results of the randomized FORTIS study in chronic lymphocytic leukemia. Ann Hematol. 2019 Apr;98(4):931-939. doi: 10.1007/s00277-019-03631-z. Epub 2019 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'The investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. CLL whatever Binet stage, but with at least one NCIWG2008 criteria indicating a need for first line treatment.\n\n * Matutes score must be 4-5/5.\n * Initial cytopenia (due to CLL) are not exclusion criteria.\n * Lymph node biopsy is needed only if suspicion of Richter syndrome.\n * Mandatory pre-therapeutic check-up: FISH in search for deletion del17p and del11q, DAT test, haptoglobin levels, creatinine clearance.\n2. Eligibility to a treatment with FCR: clearance \\> 60ml/mn, consider dose adjustments (recommended by protocol) if clearance30-60ml/mn, and comorbidity score CIRS-G≤11.\n3. Signed informed consent\n4. Age\\> or equal 18 years, ECOG PS 0-2.\n5. Estimated overall survival\\>6 months.\n6. Conserved liver function (bilirubin\\<2,5mg/dl, SGPT\\<4ULN, SGOT\\<4ULN) except infiltration due to the disease.\n7. Contraception for younger patients.\n8. Confident with the use of telephone, no disabling deafness.\n\nExclusion Criteria:\n\n1. Richter syndrome or atypical CLL (Matutes score \\<4), and/or del17p by FISH\n2. Relapse of CLL\n3. Contra-indications to fludarabine: auto-immune cytopenia, creatinine clearance\\<30 ml/mn.\n4. Serologies positive for HIV, HBV, or HCV. No active bacterial, viral or fungal infection\n5. Previous history of hypersensibility to any product used in this protocol\n6. Denial, or medical or psychological condition preventing completion of the signed informed consent.\n7. Treatment with an investigational agent, or participation to another therapeutic protocol, 30 days before participating to this study.\n8. Pregnant/breastfeeding women.\n9. CNS involvement by CLL.\n10. Presence of another cancer needing treatment (except basocellular carcinoma or cervix cancer managed with only surgery or local therapy).'}, 'identificationModule': {'nctId': 'NCT01393366', 'acronym': 'FORTIS', 'briefTitle': 'Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy', 'orgStudyIdInfo': {'id': '1030903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Without AMA', 'description': 'Patient will be follow only like usual practice', 'interventionNames': ['Other: Usual Practice']}, {'type': 'OTHER', 'label': 'With AMA', 'description': "Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.", 'interventionNames': ['Other: Telephone Intervention']}], 'interventions': [{'name': 'Telephone Intervention', 'type': 'OTHER', 'description': 'Only for arm AMA, patient will have one phone every week to evaluate physical conditions.', 'armGroupLabels': ['With AMA']}, {'name': 'Usual Practice', 'type': 'OTHER', 'description': 'None, only usual practice.', 'armGroupLabels': ['Without AMA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64109', 'city': 'Bayonne', 'country': 'France', 'facility': 'Centre Hospitalier de la côte basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '66046', 'city': 'Perpignan', 'country': 'France', 'facility': 'CH Saint Jean', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Loïc YSEBAERT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Of Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}