Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-01 @ 5:38 PM
Study NCT ID:
NCT03603795
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2018-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy
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': 'C520809', 'term': 'eltrombopag'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization between 2 arms'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-25', 'studyFirstSubmitDate': '2018-04-20', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of accident haemorrhage events ≥ grade 3', 'timeFrame': 'Until day 45', 'description': 'All accident haemorrhage event ≥ grade 3'}, {'measure': 'Number of days with platelets count <10 Giga/L', 'timeFrame': 'from baseline to the end of induction (day 45) and then at day 60, day 90, monthly until year 1 and finally at year 2, year 3 and year 5', 'description': 'Daily measurement of platelets count'}, {'measure': 'Number of platelets transfusion', 'timeFrame': 'from baseline to the end of induction (day 45)'}, {'measure': 'Time to platelets count > 100 Giga/L', 'timeFrame': 'from baseline to the end of induction (day 45) and then at day 60, day 90, monthly until year 1 and finally at year 2, year 3 and year 5', 'description': 'Daily measurement of platelets count'}, {'measure': 'Time to peripheral blood polymorphonuclear neutrophils (PMN) counts > 0.5 G/L', 'timeFrame': 'from baseline to the end of induction (day 45) and then at day 60, day 90, monthly until year 1 and finally at year 2, year 3 and year 5', 'description': 'Daily measurement of peripheral blood PMN count'}, {'measure': 'Time to haemoglobin counts > 8 g/dl', 'timeFrame': 'from baseline to the end of induction (day 45) and then at day 60, day 90, monthly until year 1 and finally at year 2, year 3 and year 5', 'description': 'Daily measurement of haemoglobin count'}, {'measure': 'Time to red blood cells transfusion independence', 'timeFrame': 'from baseline to the end of induction (day 45) and then at day 60, day 90, monthly until year 1 and finally at year 2, year 3 and year 5', 'description': 'Daily measurement of Red blood cells count and transfusion monitoring'}, {'measure': 'Eltrombopag-Emergent Adverse Events', 'timeFrame': 'Until day 90', 'description': 'Incidence and severity of Eltrombopag-Emergent Adverse Events utilizing National Cancer Institute - Common Terminology Criteria (NCI-CTC) criteria v4.03'}, {'measure': 'Evaluation of quality of life', 'timeFrame': 'At baseline and at the end of induction (maximum up to day 45)', 'description': 'EORTC Quality of Life Questionnaire - Core Questionnaire (QLQ-C30). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.\n\nEach of the multi-item scales includes a different set of items - no item occurs in more than one scale.\n\nAll of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.'}], 'primaryOutcomes': [{'measure': 'Overal survival rate', 'timeFrame': '12 months after beginning treatment', 'description': 'overall survival rate at month 12 (year 1) between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy.'}], 'secondaryOutcomes': [{'measure': 'Response rate (CR and CRi) at day 45', 'timeFrame': 'At day 45'}, {'measure': 'Leukemia Free Survival at month 12 (one year)', 'timeFrame': '12 months after beginning treatment', 'description': 'relapse measurement before month 12'}, {'measure': 'Long-term survival', 'timeFrame': '2, 3 and 5 years after first treatment administration', 'description': 'Overall survival at 2, 3 and 5 years'}, {'measure': 'Percentage of patients with platelets count > 100 Giga/L at day 45', 'timeFrame': 'At day 45', 'description': 'platelets count \\>100 Giga/L'}, {'measure': 'Time to platelet transfusion independence', 'timeFrame': 'platelets count daily from baseline to the end of induction (day 45) and then at day 60, day 90, monthly until year 1 and finally at year 2, year 3 and year 5', 'description': 'More than 3 days with platelets count ≥ 10 Giga/L'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.filo-leucemie.org', 'label': 'FILO internet site'}]}, 'descriptionModule': {'briefSummary': 'Phase II randomized placebo-controlled study to assess the impact on outcome of Eltrombopag administered to elderly patients with Acute Myeloid Leukemia (AML) receiving induction chemotherapy. A phase II multicenter and randomized placebo-controlled study', 'detailedDescription': 'Subjects will be randomized 1:1 to receive Eltrombopag or matching placebo, in double blinded.\n\nTo compare overall survival rate at 12 months between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy\n\nArm A : Eltrombopag 200 mg (100 mg/day for east Asian heritage) once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count \\> 100 x 10 Giga/L (maximum day 45)\n\nArm B : Placebo once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count \\> 100 x 10 Giga/L. (maximum day 45)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* 60 years of age.\n* AML de novo, except AML 3 and AML 7.\n* AML with no adverse cytogenetic according to Medical Research Council (MRC) 2010 classification.\n* Subjects should be eligible for intensive chemotherapy by Daunorubicine, cytarabine, Lomustine.\n* Eastern Cooperative Oncology Group (ECOG) \\< 3 (appendix 1).\n* SORROR ≤ 3 (appendix 2).\n* Adequate baseline organ function defined by the criteria below:\n\n * Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) range except cases clearly not indicative of inadequate liver function\n * Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT) ≤ 3 x ULN\n * Creatinin ≤ 1.5 x ULN\n* Adequate cardiac function with Left Ventricular Ejection fraction (LVEF) ≥50%\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n* Women will be menopausal to be enrolled\n* The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient and before the start of induction chemotherapy.\n* Affiliated to the French Social Security (Health Insurance).\n\nExclusion criteria\n\n* Subjects with a diagnosis of acute promyelocytic (M3) or megakaryocytic leukemia (M7).\n* AML with adverse cytogenetic according to the MRC 2010 classification.\n* AML secondary to Myelodysplastic syndrome (MDS), Myeloproliferative neoplasm (MPN)\n* Clinical symptoms suggesting active central nervous system leukemia, or presence of extramedullary AML.\n* Previous exposure to anthracycline.\n* Previous AML treatment other than hydroxyurea.\n* Treatment with an investigational drug within 30 days or 5 half-life whichever is longer, preceding the first dose of study medication.\n* History of thromboembolic event or other condition requiring ongoing use of anticoagulation either with warfarin or low molecular-weight heparin.\n* History of another malignancy within the past three years except basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n* Pre-existing cardiovascular disease (including congestive heart failure, New York Heart Association (NYHA) Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc \\>450 msec (QTc \\>480 msec for subjects with Bundle Branch Block).\n* Patient requiring platelets transfusion with platelets \\> 10 x 10 Giga/L, for whatever reason.\n* History of treatment with romiplostim or other Thrombopoietin receptor (TPO-R) agonists.\n* Uncontrolled active infection.\n* Any serious medical condition, laboratory abnormality, or psychiatric illness that would place the participant at an unacceptable risk or prevent them from giving informed consent.\n* Known active HIV, Hepatitis B or C infection.\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03603795', 'acronym': 'EPAG2015', 'briefTitle': 'Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'French Innovative Leukemia Organisation'}, 'officialTitle': 'A Phase II Randomized Placebo-controlled Study to Assess the Impact on Outcome of Eltrombopag Administered to Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy', 'orgStudyIdInfo': {'id': 'EPAG 2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': '55 patients will be randomized in the experimental arm A. If platelets counts \\< 100 x 10 Giga/L, patients will be treated with Eltrombopag 200 mg/day per os from day 11 of induction chemotherapy to platelets counts \\> 100 x 10 Giga/L or maximum to day 45. If platelets counts ≥ 100 x 10 Giga/L on day 11, the start of IP will be delayed until platelets \\< 100 x 10 Giga/L.\n\nChemotherapy administration would be performed among standard practice:\n\n* Daunorubicin: 60 mg/m² D1 to D3\n* Cytarabine: 100 mg/m²/day, in a continuous 24h-IV infusion D1 to D7\n* Lomustine (CCNU): 200 mg/m² per os, at D1.\n\n 200mg = 4 Tablets of 50 mg will be done more than 2 hours before Daunorubicin and cytarabine administrations, to avoid vomiting secondary to anthracycline administration.\n\nInvestigational Product (IP) will be taken at the same time daily on an empty stomach 1 hour before or 2 hours after a meal or preferably no calcium or dairy products.', 'interventionNames': ['Drug: Eltrombopag']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': '55 patients will be randomized in the comparator arm B and will received: Placebo once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count \\> 100 x 10 Giga/L (maximum day 45)\n\nPlacebo 200mg = 4 Tablets of 50 mg will be done more than 2 hours before Daunorubicin and cytarabine administrations, to avoid vomiting secondary to anthracycline administration.\n\nChemotherapy administration would be performed among standard practice:\n\n* Daunorubicin: 60 mg/m² D1 to D3\n* Cytarabine: 100 mg/m²/day, in a continuous 24h-IV infusion D1 to D7\n* Lomustine (CCNU): 200 mg/m² per os, at D1.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Eltrombopag', 'type': 'DRUG', 'otherNames': ['Arm Eltrombopag', 'Arm experimental A'], 'description': 'Eltrombopag concomitant with induction chemotherapy in patient with AML', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Arm placebo', 'Arm B'], 'description': 'Placebo concomitant with induction chemotherapy patients with AML', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU ANGERS - Maladies du sang', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '64109', 'city': 'Bayonne', 'country': 'France', 'facility': 'CH de la Côte Basque - Hématologie', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble - Hématologie Clinique', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmettes - Hématologie 2', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Saint-Eloi - Hématologie Clinique', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '68070', 'city': 'Mulhouse', 'country': 'France', 'facility': 'HOPITAL E. MULLER - Hématologie', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU HOTEL DIEU - Hématologie Clinique', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU La Milétrie - Hématologie Clinique', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Hautepierre - Hématologie', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': "Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Sponsor FILO', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Arnaud PIGNEUX, MD PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French Innovative Leukemia Organization (FILO)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Innovative Leukemia Organisation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}