PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years
Treatment Protocol For All Fragile Patients Ph' Negative Over 55 Years
1 other identifier
interventional
100
1 country
75
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2010
Longer than P75 for phase_4
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
May 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 19, 2022
January 1, 2022
12.6 years
May 18, 2011
January 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy in terms of response rate
5 years
Secondary Outcomes (2)
Efficacy in terms disease free survival
5 years
Efficacy in terms of global survival
10 years
Interventions
Eligibility Criteria
You may qualify if:
- Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'negative and not previously treated with frailty (\> 3 points in the Charlson comorbidity index)
You may not qualify if:
- LAL
- \. L3 type mature B phenotype (sIg +) or cytogenetic abnormalities characteristic of Burkitt LAL (t \[8, 14\], t \[2, 8\], t \[8, 22\]).
- 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).
- General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.
- LAL Ph 'positive (though still must register their LAL07OPH specific protocol).
- Lack of consent by the patient to use their clinical data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2011
First Posted
May 23, 2011
Study Start
May 1, 2010
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
January 19, 2022
Record last verified: 2022-01