Glivec in Ph Positive Lymphoblastic Leukemia
- Conditions
- Acute Lymphoblastic LeukemiaCromosome Philadelphia Positive
- Registration Number
- NCT00388895
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment
- Detailed Description
Pilot phase II clinical trial, prospective, multicentric and opened
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- New diagnosis LLA Ph+ (BCR/ABL) patients ≤ 65 years old
- Fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication
- Performance status 0-2 (Appendix B); Is allowed performance status > 2 because of LLA
- Patients without organ alteration: hepatic function: global bilirubin, AST, ALT, gamma-GT and alkaline phosphatase less than 2 times LSN; renal function: Creatinine < 1,5 mg/dl o Clearance creatinine > 60 ml/min; anormal renal function caused by LLA ; normal heart function (Appendix B): FEV > 50%; No Chronic respiratory illness. If the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial.
- Negative HIV serology
- Written, oral or with witness informed consent. In patients < 18 years old must be signed written and legal representative informed consent.
- No experimental chemotherapy or other experimental treatment. Allowed to begin induction chemotherapy from the diagnosis to confirm Ph. No major surgical process in the previous 14 days of the treatment Start.
- 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
- Pregnancy and women
- Blastic crisis LMC
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method % positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment. Discover if is possible to treat patients with Glivec plus Standard consolidation treatment. Discover the Glivec effect over ERM during consolidation treatment and alter transplant
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Clínico y Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Puerta del Mar
🇪🇸Cádiz, Spain
Hospital Juan Canalejo
🇪🇸La Coruña, Spain
Hospital Universitario "Germans Trias i Pujol"
🇪🇸Barcelona, Spain
Hospital Valle Hebrón
🇪🇸Barcelona, Spain
Hospital Clínico San Carlos de Madrid
🇪🇸Madrid, Spain
Hospital Son Dureta
🇪🇸Palma de Mallorca, Spain
Hospital Son Llàtzer
🇪🇸Palma de Mallorca, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital "Santa Creu i Sant Pau"
🇪🇸Barcelona, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital "Duran I Reynals"
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Valle Hebrón-Materno Infantil
🇪🇸Barcelona, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
. Hospital Clínico Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital General Universitario Morales Meseguer.
🇪🇸Murcia, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Carlos Haya
🇪🇸Málaga, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital Doce de Octubre
🇪🇸Madrid, Spain