LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
1 other identifier
interventional
100
1 country
50
Brief Summary
Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.
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 Jan 2000
Longer than P75 for phase_4
50 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
January 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 5, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedJanuary 5, 2010
January 1, 2010
5.3 years
September 5, 2007
January 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival
5 years
Interventions
1,5 mg/m2 i.v., days 1 and 8
60 mg/m2, i.v., days 1 and 8
60 mg/m2 day, i.v. or oral, days 1 to 14
10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.
12 mg/m2 i.v days 15, 16 and 17
1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)
10 mg ,15 mg or 20 mg depending of age
50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation
600 mg/m2 day, i.v., days 1 to 15 in consolidation
10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21
Eligibility Criteria
You may qualify if:
- ALL BCR/ABL+ patients Age \< 65 years No previous treatment
You may not qualify if:
- Other LLA variability
- Previous history of coronary valvular, hypertensive cardiopathy illness
- Chronic hepatic illness
- Chronic respiratory insufficiency
- Renal insufficiency not caused by LLA
- Severe neurological problems not caused by LLA
- Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Hospital General de Alicante
Alicante, Alicante, Spain
Hospital Ntra. Sra. Sonsoles
Ávila, Avila, Spain
Hospital Clínic
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital vall d'Hebrón
Barcelona, Barcelona, Spain
Hospital general de Castellón
Castelló, Castellón, Spain
Hospital Arnau de Vilanova
Lleida, Lleida, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Madrid, Spain
Hospital General Universitario Gregorio Marañón, Madrid
Madrid, Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
Hospital General Universitario Morales Meseguer.
Murcia, Murcia, Spain
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital de Navarra
Pamplona, Navarre, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Verge de la Cinta
Tortosa, Tarragona, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Clínic
Valencia, Valencia, Spain
Hospital dr. Peset
Valencia, Valencia, Spain
Hospital General Universitario
Valencia, Valencia, Spain
Hospital La Fe
Valencia, Valencia, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
Hospital de Badalona Germans Trias i Pujol
Badalona, Spain
Hospital de Sant Pau
Barcelona, Spain
Basurtuko Ospitalea
Basurto, Spain
Hospital de Cruces
Bilbao, Spain
Hospital de Jerez de la Frontera
Jerez de la Frontera, Spain
Complejo Hospitalario León
León, Spain
Complexo Hospitalario Xeral-Calde
Lugo, Spain
Clínica Puerta de Hierro
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital de la Princesa
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
Complejo Asistencial Son Dureta
Palma de Mallorca, Spain
Hospital Son Llatzer
Palma de Mallorca, Spain
Clínica Universitaria de Navarra
Pamplona, Spain
Complejo Hospitalario de Pontevedra_Hospital Montecelo
Pontevedra, Spain
Corporació Sanitaria Parc Taulí
Sabadell, Spain
Hospital de Sagunto
Sagunto, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Hospital General de Segovia
Segovia, Spain
H.U. Virgen del Rocio
Seville, Spain
Hospital Clínico de Valladolid
Valladolid, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Spain
Hospital de Galdakao
Vizcaya, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ribera Josep Mª, Dr
Germans Trias i Pujol Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 5, 2007
First Posted
September 10, 2007
Study Start
January 1, 2000
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
January 5, 2010
Record last verified: 2010-01