--- title: "PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia" nct_id: NCT00494897 overall_status: COMPLETED phase: PHASE4 sponsor: PETHEMA Foundation study_type: INTERVENTIONAL primary_condition: Acute Lymphoblastic Leukemia countries: Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00494897.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00494897" ct_last_update_post_date: 2009-05-19 last_seen_at: "2026-05-12T06:54:14.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia **NCT ID:** [NCT00494897](https://clinicaltrials.gov/study/NCT00494897) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 374 - **Lead Sponsor:** PETHEMA Foundation - **Conditions:** Acute Lymphoblastic Leukemia - **Start Date:** 1996-06 - **Completion Date:** 2007-12 - **CT.gov Last Update:** 2009-05-19 ## Brief Summary The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions. ## Detailed Description Induction therapy: Patients with standard risk receive vincristine (1,5 mg/m2)IV on days 1, 8, 15 and 22;daunorubicin (30 mg/m2)IV on days 1, 8, 15 and 22; oral or IV prednisone 60 mg/m2/day, days 1 to 27 and 30 mg/m2/day, days 28 to 35;asparaginase 10.000 UI/m2 IM or IV, days 10 to 12, 17 to 19 and 24 to 26;cyclophosphamide (500 mg/m2)IV days 1, 2 and 29; methotrexate, cytosine arabinoside and hydrocortisone, days 1 to 22. Patients older than 55 years are not treated with asparaginase and cyclophosphamide. Consolidation therapy (1): Standard risk: Mercaptopurine 50 mg/m2, PO, days 1 to 7, 28-35 and 56-63; methotrexate (3g/m2)IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV, days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56. Patients over 50 years: Mercaptopurine (50 mg/m2), PO, days 1 to 7, 28-35 and 56-63;methotrexate (1,5 g/m2) IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56. Consolidation therapy (2)/Reinduction: one cycle similar to induction. It starts one week after last dose of mercaptopurine.Dexamethasone 10 mg/m2/day,PO or IV, days 1-14 and 5 mg/m2/day, PO or IV days 15-21; VCR: 1,5 mg/m2 IV, days 1, 8 and 15; Daunorubicin 30 mg/m2 IV, days 1, 2, 8 and 9; cyclophosphamide 600 mg/m2/day IV, days 1 and 15; Asparaginase: 10.000 UI/m2 IM or IV, days 1-3 and 15-17;intrathecally treatment days 1 and 15 Maintenance therapy 1:administration of continuous chemotherapy (mercaptopurine and methotrexate) and reinductions until one year from diagnosis. * Continuous chemotherapy: * MP 50 mg/m2/day PO * MTX 20 mg/m2/week IM * Reinductions * VCR: 1,5 mg/m2 IV, day 1. * PDN: 60 mg/m2/day, IV or PO days 1 to 7 * L-ASA: 20.000 UI/m2, IM or IV day 1. * Intrathecally day 1 Seven cycles, weeks 25, 29, 33, 37, 41, 45 and 49. Maintenance therapy 2:administration of continuous chemotherapy (mercaptopurine and methotrexate) while second year from diagnosis (weeks 53 to 104). * MP 50 mg/m2/day, PO * MTX 20 mg/m2/week, IM. ## Eligibility - **Minimum age:** 15 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy Exclusion Criteria: * Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t\[8;14\], t\[2;8\], t\[8;22\]) * Mixed forms of ALL * Acute Leukemia no differentiate * Patients with coronary disorders, valvular or hypertensive cardiopathy * Patients with chronic liver disorders * Chronic pulmonary disorders * Renal insufficiency * Neurologic disfunctions * ECOG 3 and 4 * No signed consent form ``` ## Interventions - **Asparaginase** (DRUG) - **Cyclophosphamide** (DRUG) - **Cytarabine** (DRUG) - **Daunorubicin** (DRUG) - **Mercaptopurine** (DRUG) - **Prednisone** (DRUG) - **Vincristine** (DRUG) - **Methotrexate** (DRUG) - **Intrathecally treatment** (PROCEDURE) ## Primary Outcomes - **Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia** _(time frame: 2 years)_ ## Secondary Outcomes - **Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy** _(time frame: 2 years)_ - **To evaluate the treatment tolerance** _(time frame: 1 year)_ ## Locations (87) - Hospital General de Alicante, Alicante, Alicante, Spain - Hospital Ntra. Sra. Sonsoles, Ávila, Avila, Spain - Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain - Hospital Clínic, Barcelona, Barcelona, Spain - Hospital de la Santa Creu i Sant Pau, Barcelona, Barcelona, Spain - Hospital del Mar, Barcelona, Barcelona, Spain - Hospital vall d'Hebrón, Barcelona, Barcelona, Spain - Hospital Valle Hebrón-Materno Infantil, Barcelona, Barcelona, Spain - Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain - Hospital Mútua de Terrassa, Terrassa, Barcelona, Spain - Hospital general de Castellón, Castelló, Castellón, Spain - Hospital Puerta del Mar, Cadiz, Cádiz, Spain - Complejo Hospitalario Reina Sofía, Córdoba, Córdoba, Spain - Hospital Universitario Virgen de las Nieves, Granada, Granada, Spain - Hospital Juan Ramón Jiménez, Huelva, Huelva, Spain - Hospital Médico Quirúrgico Ciudad de Jaén, Jaén, Jaen, Spain - Hospital Juan Canalejo, A Coruña, La Coruña, Spain - Hospital Arnau de Vilanova, Lleida, Lleida, Spain - Clínica Puerta de Hierro, Madrid, Madrid, Spain - Hospital Clínico San Carlos de Madrid, Madrid, Madrid, Spain - Hospital de Fuenlabrada, Madrid, Madrid, Spain - Hospital General Universitario Gregorio Marañón, Madrid, Madrid, Madrid, Spain - Hospital Universitario de la Princesa, Madrid, Madrid, Spain - Hospital Universitario Princcipe de Asturias, Madrid, Madrid, Spain - . Hospital Clínico Universitario Virgen de la Victoria, Málaga, Málaga, Spain - Hospital del Río Carrión, Palencia, Palencia, Spain - Hospital Son Dureta, Palma de Mallorca, Palma de Mallorca, Spain - Hospital Central de Asturias, Oviedo, Principality of Asturias, Spain - Hospital Universitario Virgen del Rocío, Seville, Sevilla, Spain - Hospital Joan XXIII, Tarragona, Tarragona, Spain - Hospital Verge de la Cinta, Tortosa, Tarragona, Spain - Hospital Clínico Universitario de Valencia, Valencia, Valencia, Spain - Hospital Clínic, Valencia, Valencia, Spain - Hospital General Universitario, Valencia, Valencia, Spain - Hospital La Fe, Valencia, Valencia, Spain - Hospital Meixoeiro, Vigo, Vigo, Spain - Hospital Clínico Lozano Blesa, Zaragoza, Zaragoza, Spain - Complejo Hospitalario Universitario de Albacete, Albacete, Spain - Hospital Regional Universitario Infanta Cristina, Badajoz, Spain - Basurtuko Ospitalea, Basurto, Spain - Complejo Hospitalario de Cáceres, Cáceres, Spain - Hospital Nuestra Señora de Alarcos, Ciudad Real, Spain - Hospital Virgen de la Luz, Cuenca, Spain - Hospital General de Elda, Elda, Spain - Institut Català d'Oncologia,, Girona, Spain - Hospital de San Jorge, Huesca, Spain - Hospital de Jerez de la Frontera, Jerez de la Frontera, Spain - Hospital General de Lanzarote, Lanzarote, Spain - Complejo Hospitalario León, León, Spain - Complexo Hospitalario Xeral-Calde, Lugo, Spain - Hospital 12 de Octubre, Madrid, Spain - Hospital de la Princesa, Madrid, Spain - Hospital Doce de Octubre, Madrid, Spain - Hospital Puerta de Hierro, Madrid, Spain - Hospital Ramón y Cajal, Madrid, Spain - Hospital Universitario La Paz, Madrid, Spain - Althaia, Xarxa Asistencial de Manresa, Manresa, Spain - H. Carlos Haya, Málaga, Spain - Hospital General Morales Meseguer, Murcia, Spain - Hospital Santa María del Rosell, Murcia, Spain - Hospital Virgen del Castillo de Yecla, Murcia, Spain - Complejo Asistencial Son Dureta, Palma de Mallorca, Spain - Hospital Son Llatzer, Palma de Mallorca, Spain - Hospital Verge del Toro, Palma de Mallorca, Spain - Clínica Universitaria de Navarra, Pamplona, Spain - Hospital Virgen del Camino, Pamplona, Spain - Complejo Hospitalario de Pontevedra_Hospital Montecelo, Pontevedra, Spain - Hospital de Sagunto, Sagunto, Spain - Hospital Clínico de Salamanca, Salamanca, Spain - Hospital San Pedro de Alcántara, San Pedro, Spain - Clínica Sant Camil, Sant Pere de Ribes, Spain - Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain - Hospital Universitario Marqués de Valdecilla, Santander, Spain - Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain - Hospital de Santiago de Compostela, Santiago de Compostela, Spain - Hospital General de Segovia, Segovia, Spain - H.U. Virgen del Rocio, Seville, Spain - Hospital Nuestra Señora del Prado, Toledo, Spain - Hospital Virgen de la Salud, Toledo, Spain - Fundación Instituto Valenciano de Oncología, Valencia, Spain - Hospital Dr. Peset, Valencia, Spain - Hospital Francesc de Borja, Valencia, Spain - Hospital General Básico de la Defensa, Valencia, Spain - Hospital Clínico de Valladolid, Valladolid, Spain - Complejo Hospitalario Universitario de Vigo, Vigo, Spain - Hospital Txagorritxu, Vitoria-Gasteiz, Spain - Hospital de Galdakao, Vizcaya, Spain ## Recent Field Changes (last 30 days) - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.hospital general de alicante|alicante|alicante|spain` — added _(2026-05-12)_ - `locations.hospital ntra. sra. sonsoles|ávila|avila|spain` — added _(2026-05-12)_ - `locations.hospital germans trias i pujol|badalona|barcelona|spain` — added _(2026-05-12)_ - `locations.hospital clínic|barcelona|barcelona|spain` — added _(2026-05-12)_ - `locations.hospital de la santa creu i sant pau|barcelona|barcelona|spain` — added _(2026-05-12)_ - `locations.hospital del mar|barcelona|barcelona|spain` — added _(2026-05-12)_ - `locations.hospital vall d'hebrón|barcelona|barcelona|spain` — added _(2026-05-12)_ - `locations.hospital valle hebrón-materno infantil|barcelona|barcelona|spain` — added _(2026-05-12)_ - `locations.corporació sanitària parc taulí|sabadell|barcelona|spain` — added _(2026-05-12)_ - `locations.hospital mútua de terrassa|terrassa|barcelona|spain` — added _(2026-05-12)_ - `locations.hospital general de castellón|castelló|castellón|spain` — added _(2026-05-12)_ - `locations.hospital puerta del mar|cadiz|cádiz|spain` — added _(2026-05-12)_ - `locations.complejo hospitalario reina sofía|córdoba|córdoba|spain` — added _(2026-05-12)_ - `locations.hospital universitario virgen de las nieves|granada|granada|spain` — added _(2026-05-12)_ - `locations.hospital juan ramón jiménez|huelva|huelva|spain` — added _(2026-05-12)_ - `locations.hospital médico quirúrgico ciudad de jaén|jaén|jaen|spain` — added _(2026-05-12)_ - `locations.hospital juan canalejo|a coruña|la coruña|spain` — added _(2026-05-12)_ - `locations.hospital arnau de vilanova|lleida|lleida|spain` — added _(2026-05-12)_ - `locations.clínica puerta de hierro|madrid|madrid|spain` — added _(2026-05-12)_ - `locations.hospital clínico san carlos de madrid|madrid|madrid|spain` — added _(2026-05-12)_ - `locations.hospital de fuenlabrada|madrid|madrid|spain` — added _(2026-05-12)_ - `locations.hospital general universitario gregorio marañón, madrid|madrid|madrid|spain` — added _(2026-05-12)_ - `locations.hospital universitario de la princesa|madrid|madrid|spain` — added _(2026-05-12)_ - `locations.hospital universitario princcipe de asturias|madrid|madrid|spain` — added _(2026-05-12)_ - `locations.. hospital clínico universitario virgen de la victoria|málaga|málaga|spain` — added _(2026-05-12)_ - `locations.hospital del río carrión|palencia|palencia|spain` — added _(2026-05-12)_ - `locations.hospital son dureta|palma de mallorca|palma de mallorca|spain` — added _(2026-05-12)_ - `locations.hospital central de asturias|oviedo|principality of asturias|spain` — added _(2026-05-12)_ - `locations.hospital universitario virgen del rocío|seville|sevilla|spain` — added _(2026-05-12)_ - `locations.hospital joan xxiii|tarragona|tarragona|spain` — added _(2026-05-12)_ - `locations.hospital verge de la cinta|tortosa|tarragona|spain` — added _(2026-05-12)_ - `locations.hospital clínico universitario de valencia|valencia|valencia|spain` — added _(2026-05-12)_ - `locations.hospital clínic|valencia|valencia|spain` — added _(2026-05-12)_ - `locations.hospital general universitario|valencia|valencia|spain` — added _(2026-05-12)_ - `locations.hospital la fe|valencia|valencia|spain` — added _(2026-05-12)_ - `locations.hospital meixoeiro|vigo|vigo|spain` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00494897.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00494897* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*