Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-03 @ 4:48 PM
Study NCT ID:
NCT01716793
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2012-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk-adapted Therapy for Adult Acute Myeloid 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': 'D003561', 'term': 'Cytarabine'}, {'id': 'D014182', 'term': 'Transplantation, Autologous'}], 'ancestors': [{'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 354}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-31', 'studyFirstSubmitDate': '2012-10-22', 'studyFirstSubmitQcDate': '2012-10-29', 'lastUpdatePostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate.', 'timeFrame': '2 months.', 'description': 'Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission.'}, {'measure': 'Disease free survival.', 'timeFrame': '4 years.', 'description': 'Analyze the disease free survival (DFS)of patients in remission, with a therapeutic strategy adjusted to the prognostic factors.'}], 'secondaryOutcomes': [{'measure': 'Evaluations of minimal residual disease (MRD) by flow cytometry during and after treatment.', 'timeFrame': '4 years.', 'description': 'Study of the immunophenotypic characteristics of the leukemic population at diagnosis and evaluation of MRD during different treatment phases and follow-up.'}, {'measure': 'Feasibility to mobilize and collect autologous PBSC after consolidation phase.', 'timeFrame': '6 months.', 'description': 'Evaluation of mobilization failures.'}, {'measure': 'Evaluations of the CD34+ cell selection procedure and allogeneic peripheral blood stem cell (PBSC)transplantation outcome.', 'timeFrame': '4 years.', 'description': 'CD34+ cell selection from PBSC of HLA-identical siblings. Conditioning regimen. Infusion and post-transplant follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Primary AML', 'Risk-adapted treatment', 'Hematopoietic transplantation', 'CD34+ cell selection'], 'conditions': ['Leukemia, Myelocytic, Acute']}, 'descriptionModule': {'briefSummary': 'In a protocol of treatment of AML used in 1994 for adults with AML up to the age of 50 years, the Spanish CETLAM group showed a complete remission rate 75 % using the combination of daunorubicin (60 mg/m2, 3 days) plus conventional dose cytarabine (100mg/m2/day in continuous infusion during 7 days) and etoposide (100mg/m2 IV/day 3 days). If idarubicin (10 mg/m2, 3 days) was administered instead of daunorubicin, the complete remission (CR) rate in adults up to 60 years was 75%. To improve the proportion of CRs and to decrease relapse rate appearing in 50% of patients, the phase II AML-99 trial includes intermediate dose-cytarabine during induction and risk-adapted post remission treatment based on the improvement in prognostic characterization of AML and the implementation of novel transplantation techniques.', 'detailedDescription': 'Induction chemotherapy: idarubicin (12mg/m2/day intravenous), intermediate-dose cytarabine (500mg/m2/12h, intravenous) and etoposide (100mg/m2/day, intravenous) in 3+7+3 schedule. This induction therapy is repeated if complete remission (CR) is not achieved after the first course of treatment.\n\nConsolidation therapy: mitoxantrone (12mg/m2/day, intravenous, days 4, 5 and 6) and intermediate-dose cytarabine (500mg/m2/12h from day 1 to 6).\n\nRisk-stratification according to cytogenetics, courses to CR and availability of an HLA-identical sibling:\n\n* Patients in the favorable cytogenetics group \\[t(8;21), inv(16) or t(16;16)\\] are treated with high-dose cytarabine (3g/m2/12h, intravenous, days 1, 3 and 5).\n* Patients in intermediate cytogenetics group (normal karyotype and a single course to achieve the CR) receive an autologous peripheral blood stem cell (PBSC) transplant, regardless of having an HLA-identical sibling.\n* The remaining patients are considered in the high-risk group and are treated with autologous or allogeneic PBSC transplantation depending on the availability of a sibling donor. In allotransplants, CD34+ cell selection of hematopoietic cells is performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed AML, classified by FAB criteria\n* Age not superior to 60 years\n* Verbal informed consent for the chemotherapy and written for the mobilization and stem cell transplantation\n\nExclusion Criteria:\n\n* Patients treated previously for its AML with other chemotherapy different from hydroxyurea\n* Acute promyelocytic leukemia (M3)\n* Chronic myeloid leukemia in blastic crisis\n* Leukemias appearing after other myeloproliferative processes\n* Leukemias surviving after myelodysplastic syndromes with more than 6 months of evolution\n* Presence of other neoplastic disease in activity\n* Secondary AML which had appeared after cured malignancies (for instance Hodgkin disease) and those who are still exposed to alkylant agents or radiation\n* Renal and hepatic abnormal function with creatinine values and/or bilirubin two times higher than the normal threshold, except when this alteration could be attributed to the leukemia\n* Patients with a fraction of ejection very low (inferior to 40%), symptomatic cardiac insufficiency or both\n* Patients with a grave concomitant neurological or psychiatric disease\n* Positivity of HIV (donor and/or receptor)'}, 'identificationModule': {'nctId': 'NCT01716793', 'briefTitle': 'Risk-adapted Therapy for Adult Acute Myeloid Leukemia.', 'organization': {'class': 'OTHER', 'fullName': 'Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias'}, 'officialTitle': 'Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.', 'orgStudyIdInfo': {'id': 'AML-99'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Risk-adapted postremission treatment', 'description': 'Ara-C, autologous transplantation, Allogeneic HLA-identical sibling transplantation depending on risk factors (cytogenetics, courses to CR)and availability of an HLA-identical sibling, CD34+ selection.', 'interventionNames': ['Drug: Ara-C', 'Other: Autologous transplantation', 'Other: Allogeneic HLA-identical sibling transplantation', 'Other: CD34+ selection']}], 'interventions': [{'name': 'Ara-C', 'type': 'DRUG', 'description': '* Intermediate dose during induction phase to remission.\n* High-dose during consolidation phase in patients with favorable cytogenetics.', 'armGroupLabels': ['Risk-adapted postremission treatment']}, {'name': 'Autologous transplantation', 'type': 'OTHER', 'description': '* In patients with normal karyotype and one cycle of chemotherapy to achieve complete remission.\n* In patients with other cytogenetics without HLA-Identical sibling.', 'armGroupLabels': ['Risk-adapted postremission treatment']}, {'name': 'Allogeneic HLA-identical sibling transplantation', 'type': 'OTHER', 'description': '* Patients without favorable or normal karyotype(and one course to CR).\n* Patients with normal karyotype who need two cycles of chemotherapy to achieve CR, and other cytogenetics.', 'armGroupLabels': ['Risk-adapted postremission treatment']}, {'name': 'CD34+ selection', 'type': 'OTHER', 'description': 'In allotransplants, it is performed a CD34+ cell selection of peripheral blood stem cell transplantation.', 'armGroupLabels': ['Risk-adapted postremission treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08022', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Centro Medico Teknon', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Jordi Esteve', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': "L'Hospitalet Del Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'ICO Hospital Universitari de Bellvitge'}, {'zip': '15006', 'city': 'A Coruña', 'state': 'Coruña', 'country': 'Spain', 'facility': 'Hospital A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '17007', 'city': 'Girona', 'state': 'Girona', 'country': 'Spain', 'facility': 'Hopital Universitari de Girona Dr. Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '25006', 'city': 'Lleida', 'state': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Universitari Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Malaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Mallorca', 'country': 'Spain', 'facility': 'Hospital Universitari Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Mallorca', 'country': 'Spain', 'facility': 'Joan Bargay', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '30008', 'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital General Universitario de Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '43007', 'city': 'Tarragona', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Universitari Joan XXIII', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'zip': '43517', 'city': 'Tortosa', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Verge de la Cinta', 'geoPoint': {'lat': 40.81249, 'lon': 0.5216}}, {'zip': '08225', 'city': 'Terrassa', 'state': 'Terrassa', 'country': 'Spain', 'facility': 'Mutua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '496010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '41010', 'city': 'Valladolid', 'state': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Universitario Rio Hortega', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Jorge Sierra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, {'name': 'Salut Brunet, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}