PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years
NCT ID: NCT01358201
Last Updated: 2022-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2010-05-31
2022-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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vINCRISTINE
Dexamethasone
Methotrexate
Cytosine arabinoside
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1\. L3 type mature B phenotype (sIg +) or cytogenetic abnormalities characteristic of Burkitt LAL (t \[8, 14\], t \[2, 8\], t \[8, 22\]).
2 . biphenotypic acute leukemias and bilinear 3 . acute undifferentiated leukemia 4 . Patients with a Charlson comorbidity index less than or equal to 3 (and therefore that could potentially benefit from more intensive treatment PETHEMA LAL-07OLD).
5 . General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.
6 . LAL Ph 'positive (though still must register their LAL07OPH specific protocol).
7 . Lack of consent by the patient to use their clinical data
55 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Responsible Party
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Locations
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H. Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Juan Canalejo
A Coruña, , 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
Jaén, , Spain
H. de Jerez
Jerez de la Frontera, , Spain
Complejo Hospitalario León
León, , 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 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 General Morales Meseguer
Murcia, , Spain
Hospital Morales Messeguer. Murcia
Murcia, , Spain
Hospital Sta. Maria del Rosell
Murcia, , 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
Seville, , 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
Vinaròs, , Spain
Hospital Clinico Lozano Blesa
Zaragoza, , Spain
Hospital Lozano Blesa. Zaragoza
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Prosper Felipe, Dr
Role: primary
Deben Guillermo, Dr
Role: primary
Peñalver Francisco, Dr
Role: primary
Fernandez Abellan Pascual, Dr
Role: primary
Fernández Abellán Pascual, Dr
Role: primary
Ribera Josep Mª, Dr
Role: primary
Esteve Jordi, Dr
Role: primary
Sierra Jordi, Dr
Role: primary
Boqué Concha, Dr
Role: primary
Beltran de Heredia José Mª, Dr
Role: primary
Bergua Juan Miguel, Dr
Role: primary
Torres Antonio, Dr
Role: primary
Fernández Antonio, Dr
Role: primary
Alcala Antonio, Dr
Role: primary
José Luis Guzmán Zamudio, Dr
Role: primary
Sanchez Juan Manuel, Dr
Role: primary
Román Alejandro, Dr
Role: primary
Lahuerta juan José, Dr
Role: primary
Martínez Rafael, Dr
Role: primary
Diaz Mediavilla Joaquin, Dr
Role: primary
Hernández Rivas José Angel, Dr
Role: primary
Adrián Alegre, Dr
Role: primary
Canales Miguel Ángel, Dr
Role: primary
María Casanova Espinosa, Dr
Role: primary
Barrios Manuel, Dr
Role: primary
Amigo Mª Luz, Dr
Role: primary
Rayón MC, Dr
Role: primary
Ortega Frenando, Dr
Role: primary
Del Cañizo Consuelo, Dr
Role: primary
San Miguel Jesús, Dr
Role: primary
Mateos Maria Victoria, Dr
Role: backup
Hernández Rivas Jesús Mª, Dr
Role: primary
Mateos Mª Victoria, Dr
Role: primary
Martín Sánchez Jesús, Dr
Role: primary
Escoda Lourdes, Dr
Role: primary
Tormo Mar, Dra
Role: primary
Terol Maria José, Dr
Role: primary
Ferrer Secundino, Dr
Role: primary
Carbonell Félix, Dr
Role: primary
Olave Mª Teresa, Dr
Role: primary
Related Links
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Pethema Foundation
Other Identifiers
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PETHEMA LAL-07FRAIL
Identifier Type: -
Identifier Source: org_study_id
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