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Brief Title: PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years
Official Title: Treatment Protocol For All Fragile Patients Ph' Negative Over 55 Years
Study ID: NCT01358201
Brief Summary: The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and, consequently, the results of treatment are substantially lower. Additionally, elderly patients tolerate the drugs considered relatively low-key in the management of the LAL and suffer more toxicity. Although the LAL is much more common in patients over 60 years of age than in younger adults, older adults with ALL are clearly underrepresented in prospective controlled studies. A good portion of elderly patients are not able to tolerate the intensity of the standard treatment applied to children or young adults and a significant portion of them receive only palliative or supportive treatment. The data in the literature relating specifically to the elderly population are scarce and most of them have obtained a stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date, the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients because this protocol less aggressive than those used in high-risk ALL. However, the development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a relatively common type of LAL in the older patient, requires a differentiated treat these patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a significant benefit in survival related to the reduction of treatment (removal of the L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a reduction in toxicity
Detailed Description: Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml / day. allopurinol 300 mg / day. gastric protection (as center). daily monitoring of blood glucose daily monitoring of renal function. Intrathecal treatment (diagnosis and prophylactic / therapeutic) day -5: 12 mg were administered intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition of CNS involvement by LAL (and its therapeutic consequences) based on morphological observation of blasts in CSF cytocentrifuge. Remission induction : Tolerance prephase period can be used to establish the final indication of treatment (standard protocol or frail patients). Day 0 is free of treatment and is considered as +1 the first day of induction. Systemic treatment * Vincristine (VCR) 1 mg (absolute dose) EV 1, 8, 15 and 22. * Dexamethasone (DEX): 10 mg/m2 EV, IM or PO days 1-2, 8-9 days 15-16, 22-23. Intrathecal chemotherapy Triple therapy was administered with methotrexate (MTX), cytosine arabinoside (ARA-C) and hydrocortisone, days 1, 8, 15 and 22 (five doses total prophylactic between prephase and induction): MTX 12 mg ARA-C 40 mg Dexamethasone 4 mg If initial infiltration of the CNS is administered once every 72 hours until the disappearance of blast cell morphology CSF (cytocentrifugation) in at least two consecutive taps. Alternatively be administered liposomal cytarabine (DepoCyt) fortnightly if authorized by the center or in the context of a clinical trial Maintenance treatment of first year : Maintenance during the first year will start after full recovery after induction and after complete reassessment of the disease (including myelogram) and will last until one year from the time of documentation of complete remission. The basic treatment to include mercaptopurine 50 mg/m2 PO day and methotrexate 20 mg/m2 IM weekly. Once every 3 months will be added to maintenance treatment a "mini-reinduction" consisting * VCR: 1 mg (absolute dose), i.v., day 1. * Dexamethasone 40 mg / day, i.v. or p.o., days 1-2. * Not considered more doses of triple intrathecal therapy. Reinduction only be practiced during the first year after remission, so a total of 4 quarterly. Maintenance of the second year: After the first year of maintenance will perform a complete reassessment of the disease (including myelogram) and if the patient remains in complete remission maintenance will continue (without reinduction) until two years from the time of diagnosis. The initial dose of mercaptopurine and methotrexate will be identical to the first year. Must comply (by increases or decreases of 20% of the dose) to maintain the numbers of neutrophil counts between 1.5 and 3x109/l and platelets above 100x109 / L
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
H. Son Llatzer, Palma de Mallorca, Baleares, Spain
Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain
Clínica Universitaria de Navarra, Pamplona, Navarra, Spain
Complejo Hospitalario Universitario de Albacete, Albacete, , Spain
Fundación Hospital Alcorcón, Alcorcón, , Spain
Hospital de Alcorcón, Alcorcón, , Spain
Hoapital General, Alicante, , Spain
Hospital General de Alicante, Alicante, , Spain
Hospital General de Alicante, Alicante, , Spain
Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Clinic y Provincial de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau., Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Valle Hebrón, Barcelona, , Spain
Institut Català d'oncología, Barcelona, , Spain
Basurtuko Ospitalea, Basurto, , Spain
Hospital de Cruces, Bilbao, , Spain
Complejo Hospitalario de Cáceres, Cáceres, , Spain
Complejo Hospitalario Reina Sofía, Córdoba, , Spain
Area Hospitalaria Juan Ramón Jimenez, Huelva, , Spain
Hospital Médico Quirúrgico Ciudad de Jaén, Jaen, , Spain
H. de Jerez, Jerez de la Frontera, , Spain
Hospital Juan Canalejo, La Coruña, , Spain
Complejo Hospitalario León, Leon, , Spain
Hospital Arnau de Vilanova, Lleida, , Spain
Complexo Hospitalario Xeral-Calde, Lugo, , Spain
Clínica La Concepción, Madrid, , Spain
Clínica Puerta de Hierro, Madrid, , Spain
Clínica Rúber, Madrid, , Spain
Fundación Jiménez Díaz, Madrid, , Spain
Hospital 12 de Octubre. Madrid, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Clínico San Carlos de Madrid, Madrid, , Spain
Hospital de Fuenlabrada, Madrid, , Spain
Hospital de la Princesa, Madrid, , Spain
Hospital de Madrid, S.A.- Norte Hospital General, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Althaia, Xarxa Asistencial de Manresa, Manresa, , Spain
Fundación Hospital Sant Joan de Déu de Martorell, Martorell, , Spain
Hospital General Morales Meseguer, Murcia, , Spain
Hospital Morales Messeguer. Murcia, Murcia, , Spain
Hospital Sta. Maria del Rosell, Murcia, , Spain
. Hospital Clínico Universitario Virgen de la Victoria, Málaga, , Spain
Complejo Hospital Costa del Sol, Málaga, , Spain
H. Carlos Haya, Málaga, , Spain
Hospital Carlos Haya, Málaga, , Spain
Hospital Central de Asturias, Oviedo, , Spain
Hospital del Río Carrión, Palencia, , Spain
Complejo Asistencial Son Dureta, Palma de Mallorca, , Spain
Complejo Hospitalario de Pontevedra_Hospital Montecelo, Pontevedra, , Spain
Complejo Hospitalario de Pontevedra_Hospital Provincial, Pontevedra, , Spain
Corporació Sanitaria Parc Taulí, Sabadell, , Spain
Hospital Clinico Universitario, Salamanca, , Spain
Hospital Clínico de Salamanca, Salamanca, , Spain
Hospital Clínico Universitario de Salamanca, Salamanca, , Spain
Hospital Clínico Universitario de Salamanca, Salamanca, , Spain
Clínica Sant Camil, Sant Pere de Ribes, , Spain
Hoaspital Marqués de Valdecilla, Santander, , Spain
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, , Spain
Hospital General de Segovia, Segovia, , Spain
Complejo Hospitalario Regional Virgen del Rocío, Sevilla, , Spain
Hospital Joan XXIII, Tarragona, , Spain
Fundación Instituto Valenciano de Oncología, Valencia, , Spain
Hoapital La Fe, Valencia, , Spain
Hospital Clínico de Valencia., Valencia, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
Hospital Clínic, Valencia, , Spain
Hospital Dr Pesset, Valencia, , Spain
Hospital General, Valencia, , Spain
Hospital La Fe, Valencia, , Spain
Hospital Clínico de Valladolid, Valladolid, , Spain
Complejo Hospitalario Universitario de Vigo, Vigo, , Spain
Comarcal de Vinaros, Vinaros, , Spain
Hospital Clinico Lozano Blesa, Zaragoza, , Spain
Hospital Lozano Blesa. Zaragoza, Zaragoza, , Spain