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LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Phase
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Status
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Age
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Protocol IDs
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Phase IV
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Treatment
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Active
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65 and under
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Other
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LAL-Ph-2000
NCT00526305
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Trial Description
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. Further Study Information Remission Induction: - Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
- Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
- Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
- L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13
Results: 1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks 2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C Intrathecal chemotherapy: Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22 CONSOLIDATION TREATMENT 1 Start in two weeks after last dose of induction chemotherapy: - Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
- Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
- VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
- ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
- Intrathecal treatment, days 28 and 56.
6.4. CONSOLIDATION TREATMENT 2 Start in a week after last dose of mercaptopurine of previous cycle - 10 mg/m2 day, p.o. or i.v. days 1-14
- 5 mg/m2 day, p.o. or i.v., days 15-21
- Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
- Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
- CFM 600 mg/m2 day, i.v., days 1 and 15
- L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
- Intrathecal treatment days 1 and 15.
TRANSPLANTATION Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment. Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1 Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching Eligibility Criteria Inclusion Criteria: ALL BCR/ABL+ patients Age < 65 years No previous treatment Exclusion Criteria: 1. Other LLA variability 2. Previous history of coronary valvular, hypertensive cardiopathy illness 3. Chronic hepatic illness 4. Chronic respiratory insufficiency 5. Renal insufficiency not caused by LLA 6. Severe neurological problems not caused by LLA 7. Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
Trial Contact Information
Trial Lead Organizations/Sponsors Program for the Study and Treatment of Hematological Malignancies | Ribera Josep Mª, Dr | | Study Chair |
Trial Sites
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| Spain |
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Albacete |
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| | | | | | | | Hospital General de Albacete |
| | | Santiago José, Dr | Principal Investigator |
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Alicante |
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| | | Hospital General - Alicante |
| | | Rivas Concepción, Dr | Principal Investigator |
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Avila |
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| | | Hospital Nuestra Senora de Sonsoles |
| | | Barez Abelardo, Dr | |
| | | Barez Abelardo, Dr | Principal Investigator |
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Badalona |
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| | | Hospital Universitari Germans Trias i Pujol |
| | | Oriol Albert, DR | Principal Investigator |
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Barcelona |
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| | | Hospital Clinic de Barcelona |
| | | Rovira Montserrat, Dr | Principal Investigator |
| | | Hospital de la Santa Cruz i Sant Pau |
| | | Brunet Salut, Dr | Principal Investigator |
| | | Hospital Del Mar |
| | | Besses Carles, Dr | |
| | | Besses Carles, Dr | Principal Investigator |
| | | Vall d'Hebron University Hospital |
| | | Font Julià, Dr | Principal Investigator |
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Basurto |
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| | | Hospital de Basurto |
| | | Beltran de Heredia José Mª, Dr | |
| | | Beltran de Heredia Jose Mª, Dr | Principal Investigator |
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Bilbao |
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| | | Hospital de Cruces |
| | | García Juan Carlos, Dr | Principal Investigator |
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Castello |
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| | | Hospital General de Castellon |
| | | García Raimundo, Dr | |
| | | Garcia Raimundo, Dr | Principal Investigator |
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Jerez de la Frontera |
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| | | Hospital General de Jerez de la Frontera |
| | | León Angel, Dr | Principal Investigator |
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Leon |
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| | | Complejo Hospitalario de Leon |
| | | Ramos Fernando, Dr | Principal Investigator |
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Lleida |
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| | | Hospital Universitari Arnau de Vilanova |
| | | Sanchez Juan Manuel, Dr | |
| | | Sanchez Juan Manuel, Dr | Principal Investigator |
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Lugo |
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| | | Hospital Xeral de Lugo |
| | | Arias Jesús, Dr | Principal Investigator |
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Madrid |
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| | | Clinica Puerta de Hierro |
| | | Krisnk Isabel, Dr | Principal Investigator |
| | | Hospital de la Princesa |
| | | Adrián Alegre, Dr | |
| | | Alegre Adrián, Dr | |
| | | Alegre Adrián, Dr | Principal Investigator |
| | | Hospital General Universitario Gregorio Maranon |
| | | Serrano David, Dr | |
| | | Serrano David, Dr | Principal Investigator |
| | | Hospital Universitario 12 de Octubre |
| | | de la Serna Javier, Dr | Principal Investigator |
| | | Hospital Universitario San Carlos |
| | | Diaz Mediavilla Joaquin, Dr | |
| | | Díaz Mediavilla Joaquín, Dr | Principal Investigator |
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Málaga |
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| | | Hospital Regional Carlos Haya De Malaga |
| | | Negri Silvia, Dr | Principal Investigator |
| | | Hospital Universitario Virgen de la Victoria |
| | | Moreno Mª José, Dr | Principal Investigator |
| | | del Castillo Santiago, Dr | |
| | | del Castillo Santiago, Dr | Principal Investigator |
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Manresa |
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| | | Althaia Xarxa Asistencial de Manresa |
| | | Subira Maricel, Dr | Principal Investigator |
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Murcia |
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| | | Hospital General Universitario Morales Meseguer |
| | | De Arriba Felipe, Dr | Principal Investigator |
| | | Heras Inmaculada, Dr | Principal Investigator |
| | | Hospital Santa Maria del Rosell |
| | | Ibañez Jerónima, Dr | Principal Investigator |
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Oviedo |
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| | | Hospital Universitario Central de Asturias |
| | | Carrera Dolores, Dr | |
| | | Carrera Dolores, Dr | Principal Investigator |
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Palma de Mallorca |
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| | | Hospital Son Dureta |
| | | Sampol Antonia | Principal Investigator |
| | | Hospital Son Llatzer |
| | | Bargay Joan, Dr | Principal Investigator |
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Pamplona |
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| | | Clinica Universitaria |
| | | Prosper Felipe, Dr | Principal Investigator |
| | | Perez Equiza Encarnación, Dr | |
| | | Perez Equiza Encarnación, Dr | Principal Investigator |
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Pontevedra |
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| | | Complejo Hospitalario de Pontevedra |
| | | Allegue Mª José, Dr | Principal Investigator |
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Sabadell |
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| | | Hospital de Sabadell |
| | | Rámila Elena, Dr | Principal Investigator |
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Sagunto |
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| | | Hospital de Sagunto |
| | | Navarro Isabel, Dr | Principal Investigator |
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Salamanca |
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| | | University Hospital - Salamanca |
| | | Hernández Rivas Jesús Mª, Dr | Principal Investigator |
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Santiago de Compostela |
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| | | Santiago de Compostela University Hospital |
| | | Bello Jose Luis, Dr | Principal Investigator |
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Segovia |
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| | | Hospital General de Segovia |
| | | Hernández José Mariano | Principal Investigator |
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Sevilla |
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| | | Hospital Universidad Virgen Del Rocio |
| | | Parody Ricardo, Dr | Principal Investigator |
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Tenerife |
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| | | Hospital Universitario de Canarias |
| | | Bernardo Gonzalez, Dr | Principal Investigator |
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Tortosa |
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| | | Hospital de Tortosa Verge de la Cinta |
| | | Font llorenç, Dr | |
| | | Font Llorenç, Dr | Principal Investigator |
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Valencia |
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| | | Hospital Clinico Universitario de Valencia |
| | | Terol Maria José, Dr | |
| | | Terol Mª José, Dr | Principal Investigator |
| | | Solano Carlos, Dr | |
| | | Solano Carlos, Dr | Principal Investigator |
| | | Hospital General Universitario Valencia |
| | | Sanchez Magdalena, Dr | |
| | | Sanchez Magdalena, Dr | Principal Investigator |
| | | Hospital Universitario Dr. Peset |
| | | Ferrer Secundino, Dr | |
| | | Ferrer Secundino, Dr | Principal Investigator |
| | | Hospital Universitario La Fe |
| | | Sanz Miguel Angel, Dr | Principal Investigator |
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Valladolid |
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| | | Universidad de Valladolid |
| | | Fernandez Calvo Francisco, Dr | Principal Investigator |
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Vigo |
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| | | Complejo Hospitalario Xeral de Vigo |
| | | Poderós Concepción, Dr | Principal Investigator |
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Vizcaya |
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| | | Hospital de Galdakao |
| | | Ojanguren Jesús, Dr | Principal Investigator |
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Zaragoza |
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| | | Hospital Clinico Universitario Lozano Blesa |
| | | Palomera Luis, Dr | |
| | | Palomera Luis, Dr | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00526305
Information obtained from ClinicalTrials.gov on July 16, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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