Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-11 @ 2:12 PM
Study NCT ID:
NCT00526305
Status:
COMPLETED
Last Update Posted:
2010-01-05
First Post:
2007-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-03', 'studyFirstSubmitDate': '2007-09-05', 'studyFirstSubmitQcDate': '2007-09-06', 'lastUpdatePostDateStruct': {'date': '2010-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Lymphoblastic Leukemia', 'Chromosome Philadelphia positive'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aehh.org', 'label': 'Spanish Association of Haematology'}]}, 'descriptionModule': {'briefSummary': 'Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.', 'detailedDescription': 'Remission Induction:\n\n* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8\n* Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.\n* Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14\n* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13\n\nResults:\n\n1\\. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks\n\n2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C\n\nIntrathecal chemotherapy:\n\nTreatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22\n\nCONSOLIDATION TREATMENT 1\n\nStart in two weeks after last dose of induction chemotherapy:\n\n* Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63\n* Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.\n* VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42\n* ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43\n* Intrathecal treatment, days 28 and 56.\n\n6.4. CONSOLIDATION TREATMENT 2\n\nStart in a week after last dose of mercaptopurine of previous cycle\n\n* Dexamethasone (DXM):\n* 10 mg/m2 day, p.o. or i.v. days 1-14\n* 5 mg/m2 day, p.o. or i.v., days 15-21\n* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15\n* Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.\n* CFM 600 mg/m2 day, i.v., days 1 and 15\n* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17\n* Intrathecal treatment days 1 and 15.\n\nTRANSPLANTATION\n\nHematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.\n\nHematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1\n\nHematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nALL BCR/ABL+ patients Age \\< 65 years No previous treatment\n\nExclusion Criteria:\n\n1. Other LLA variability\n2. Previous history of coronary valvular, hypertensive cardiopathy illness\n3. Chronic hepatic illness\n4. Chronic respiratory insufficiency\n5. Renal insufficiency not caused by LLA\n6. Severe neurological problems not caused by LLA\n7. Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA'}, 'identificationModule': {'nctId': 'NCT00526305', 'briefTitle': 'LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive', 'organization': {'class': 'OTHER', 'fullName': 'PETHEMA Foundation'}, 'officialTitle': 'LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive', 'orgStudyIdInfo': {'id': 'LAL-Ph-2000'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vincristine', 'type': 'DRUG', 'description': '1,5 mg/m2 i.v., days 1 and 8'}, {'name': 'Daunorubicin', 'type': 'DRUG', 'description': '60 mg/m2, i.v., days 1 and 8'}, {'name': 'Prednisone', 'type': 'DRUG', 'description': '60 mg/m2 day, i.v. or oral, days 1 to 14'}, {'name': 'L-Asparaginase', 'type': 'DRUG', 'description': '10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.'}, {'name': 'Mitoxantrone', 'type': 'DRUG', 'description': '12 mg/m2 i.v days 15, 16 and 17'}, {'name': 'Cytosine Arabinoside', 'type': 'DRUG', 'description': '1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)'}, {'name': 'Hydrocortisone', 'type': 'DRUG', 'description': '10 mg ,15 mg or 20 mg depending of age'}, {'name': 'Mercaptopurine', 'type': 'DRUG', 'description': '50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation'}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '600 mg/m2 day, i.v., days 1 to 15 in consolidation'}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': '10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Ávila', 'state': 'Avila', 'country': 'Spain', 'facility': 'Hospital Ntra. Sra. Sonsoles', 'geoPoint': {'lat': 40.65724, 'lon': -4.69951}}, {'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': "Hospital vall d'Hebrón", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Castelló', 'state': 'Castellón', 'country': 'Spain', 'facility': 'Hospital general de Castellón', 'geoPoint': {'lat': 41.01149, 'lon': 0.84856}}, {'city': 'Lleida', 'state': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón, Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de la Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital General Universitario Morales Meseguer.', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Málaga', 'state': 'Málaga', 'country': 'Spain', 'facility': '. Hospital Clínico Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Hospital de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Tortosa', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Verge de la Cinta', 'geoPoint': {'lat': 40.81249, 'lon': 0.5216}}, {'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínic', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital dr. Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General Universitario', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Zaragoza', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clínico Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'city': 'Albacete', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Albacete', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}, {'city': 'Badalona', 'country': 'Spain', 'facility': 'Hospital de Badalona Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Basurto', 'country': 'Spain', 'facility': 'Basurtuko Ospitalea'}, {'city': 'Bilbao', 'country': 'Spain', 'facility': 'Hospital de Cruces', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'city': 'Jerez de la Frontera', 'country': 'Spain', 'facility': 'Hospital de Jerez de la Frontera', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'city': 'León', 'country': 'Spain', 'facility': 'Complejo Hospitalario León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'city': 'Lugo', 'country': 'Spain', 'facility': 'Complexo Hospitalario Xeral-Calde', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Clínica Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de la Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Manresa', 'country': 'Spain', 'facility': 'Althaia, Xarxa Asistencial de Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'H. Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital General Morales Meseguer', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Santa María del Rosell', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Complejo Asistencial Son Dureta', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Hospital Son Llatzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clínica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Pontevedra', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Pontevedra_Hospital Montecelo', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'city': 'Sabadell', 'country': 'Spain', 'facility': 'Corporació Sanitaria Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'city': 'Sagunto', 'country': 'Spain', 'facility': 'Hospital de Sagunto', 'geoPoint': {'lat': 39.68333, 'lon': -0.26667}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Segovia', 'country': 'Spain', 'facility': 'Hospital General de Segovia', 'geoPoint': {'lat': 40.94808, 'lon': -4.11839}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'H.U. Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Galdakao'}], 'overallOfficials': [{'name': 'Ribera Josep Mª, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Germans Trias i Pujol Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PETHEMA Foundation', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pethema', 'oldOrganization': 'pethema'}}}}