Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT01540812
Status:
COMPLETED
Last Update Posted:
2020-03-09
First Post:
2012-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS
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': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C042705', 'term': 'pegaspargase'}], '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': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'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': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 418}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '2 years', 'description': 'Improve the results of the protocol ALL-AR-03 with modifications in the study methodology of residual disease: centralized, Biomed protocols and the cut-off - \\<0.01% - internationally accepted and changes in the induction and consolidation treatment, without altering the overall design'}], 'secondaryOutcomes': [{'measure': 'Evaluate CR rate with addition of PEG-ASP in the induction phase', 'timeFrame': '2 years'}, {'measure': 'Standarization of minimal residual disease', 'timeFrame': '2 years', 'description': 'Determination of minimal residual disease in a central laboratory trying to homogenice the results'}, {'measure': 'To assess the toxic mortality', 'timeFrame': '2 years', 'description': 'To assess whether the reduction of daunorubicin in induction and changes in the consolidation drugs reduce toxic mortality in patients in complete remission'}, {'measure': 'Assess the proportion of non-responders or slow responders', 'timeFrame': '2 years'}, {'measure': 'Overall survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Lymphoblastic Leukemia'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '33150388', 'type': 'DERIVED', 'citation': 'Ribera JM, Morgades M, Ciudad J, Montesinos P, Esteve J, Genesca E, Barba P, Ribera J, Garcia-Cadenas I, Moreno MJ, Martinez-Carballeira D, Torrent A, Martinez-Sanchez P, Monsalvo S, Gil C, Tormo M, Artola MT, Cervera M, Gonzalez-Campos J, Rodriguez C, Bermudez A, Novo A, Soria B, Coll R, Amigo ML, Lopez-Martinez A, Fernandez-Martin R, Serrano J, Mercadal S, Cladera A, Gimenez-Conca A, Penarrubia MJ, Abella E, Vall-Llovera F, Hernandez-Rivas JM, Garcia-Guinon A, Bergua JM, de Rueda B, Sanchez-Sanchez MJ, Serrano A, Calbacho M, Alonso N, Mendez-Sanchez JA, Garcia-Boyero R, Olivares M, Barrena S, Zamora L, Granada I, Lhermitte L, Feliu E, Orfao A. Chemotherapy or allogeneic transplantation in high-risk Philadelphia chromosome-negative adult lymphoblastic leukemia. Blood. 2021 Apr 8;137(14):1879-1894. doi: 10.1182/blood.2020007311.'}]}, 'descriptionModule': {'briefSummary': 'Trial protocol intended the optimization of induction treatment with:\n\n1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation.\n2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of high doses of anthracyclines has not brought higher response rates or longer duration\n3. Replacing the poor cytological response at day 14 by the level of ER at the end of induction as a criterion to decide the further treatment (consolidation or second induction), so as to have only one criterion (the ER) throughout the study to decision making.\n\nFor another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2) in patients with ALL-T, since there is recent evidence of a higher response rate with this strategy.\n\nPerforming an allo-HSCT early (after one cycle of consolidation) for patients with inadequate level of ER after two cycles of induction or in those patients who required two courses of induction and have obtained proper ER after the second.\n\nConducting studies of RD centrally by cytofluorometry following Euroflow consensus standards, to avoid bias in making treatment decisions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ALL patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ALL de novo high-risk criteria\n* Age 15-55 years (55-60 years patients will be included at the discretion of the medical team that will attend)\n* No prior treatment, except Emergency leukapheresis Emergency treatment of hyperleukocytosis with hydroxyurea Urgent cranial irradiation (one dose) for CNS leukostasis Mediastinal irradiation for urgent superior vena cava syndrome\n* General condition suitable scale (ECOG 0-2), or\\> 2 if due to ALL\n* Negative pregnancy test for women of childbearing age\n* Written informed consent because, although the protocol does not include the use of investigational drugs, biological samples sent there for them\n\nExclusion Criteria:\n\n* L3 type ALL or mature phenotype B (sIg +) or cytogenetic abnormalities characteristic of mature B-ALL (t (8; 14), t (2, 8), t (8; 22)). For these patients is available BURKIMAB protocol.\n* LAL Ph (BCR-ABL) positive. For these patients have the protocol ALL-Ph-08 (if under 55) or LALOPh (if over 55).\n* Lymphoid blast crisis of chronic myeloid leukemia\n* Biphenotypic acute leukemia or bilinear according to the criteria of EGIL group\n* Undifferentiated acute leukemias\n* Patients with a history of coronary artery disease, valvular or hypertensive heart disease, contraindicating the use of anthracyclines\n* Patients with chronic phase of activity\n* Patients with severe chronic respiratory failure\n* Kidney failure due to ALL\n* Serious neurological disorder not due to the LAL\n* History of pancreatitis\n* Pregnancy or breastfeeding\n* Mental or psychiatric illness preventing informed consent is given for sending samples or properly follow the study\n* General condition affected, not attributable to the ALL'}, 'identificationModule': {'nctId': 'NCT01540812', 'briefTitle': 'Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS', 'organization': {'class': 'OTHER', 'fullName': 'PETHEMA Foundation'}, 'orgStudyIdInfo': {'id': 'LAL-AR/2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud', 'description': 'Vincristine in induction:5 mg/m2 i.v. days 1, 8, 15 and 22 in induction phase Daunorubicin in induction 45 mg/m2 i.v. days 1, 8, 15 and 22 Prednisone in induction: 60 mg/m2/ day, i.v. o p.o., days 1 to 14; 30 mg/m2/day, i.v. o p.o., days 15 to 21; 15 mg/m2/day i.v. o p.o., days 21 to 28 Metotrexato 12 mg days 1 and 22 (intrathecal) Cytarabine (ARA-C): 30 mg days 1 and 22 (intrathecal) Hydrocortisone: 20 mg days 1 and 22 (intrathecal) Idarubicin-induction 2 12 mg/m2, i.v., days 1, 3 and 5 Fludarabine in induction-2: Fludarabine 30 mg/m2, i.v., days, 1 to 5', 'interventionNames': ['Drug: Vincristine in induction', 'Drug: Daunorubicin in induction', 'Drug: Prednisone in induction', 'Drug: Metotrexato in induction', 'Drug: Cytarabine in induction', 'Drug: Hydrocortisone in induction', 'Drug: Idarubicin in induction-2', 'Drug: Fludarabine in induction-2', 'Drug: Ara-C in induction-2', 'Drug: G-CSF in induction-2', 'Drug: Dexamethasone in consolidation-1', 'Drug: Vincristrine in consolidation-1', 'Drug: Metotrexato in consolidation-1', 'Drug: PEG-ASP in consolidation-1', 'Drug: Dexamethasone in consolidation-2', 'Drug: ARA-C in consolidation-2', 'Drug: PEG-ASP in consolidation-2', 'Drug: Dexamethasone in consolidation-3', 'Drug: Vincristine in consolidation-3', 'Drug: Metotrexato in consolidation-3', 'Drug: PEG-ASP in consolidation-3', 'Procedure: allogeneic HSCT', 'Procedure: Allo HSCT with reduced-intensity conditioning']}], 'interventions': [{'name': 'Vincristine in induction', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Daunorubicin in induction', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Prednisone in induction', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Metotrexato in induction', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Cytarabine in induction', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Hydrocortisone in induction', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Idarubicin in induction-2', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Fludarabine in induction-2', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Ara-C in induction-2', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'G-CSF in induction-2', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Dexamethasone in consolidation-1', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Vincristrine in consolidation-1', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Metotrexato in consolidation-1', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'PEG-ASP in consolidation-1', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Dexamethasone in consolidation-2', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'ARA-C in consolidation-2', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'PEG-ASP in consolidation-2', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Dexamethasone in consolidation-3', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Vincristine in consolidation-3', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Metotrexato in consolidation-3', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'PEG-ASP in consolidation-3', 'type': 'DRUG', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'allogeneic HSCT', 'type': 'PROCEDURE', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}, {'name': 'Allo HSCT with reduced-intensity conditioning', 'type': 'PROCEDURE', 'armGroupLabels': ['V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + Flud']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PETHEMA Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}