Status:
UNKNOWN
Chemotherapy and Imatinib in Young Adults With Acute Lymphoblastic Leukemia Ph (BCR-ABL) POSITIVE
Lead Sponsor:
PETHEMA Foundation
Conditions:
Acute Lymphoblastic Leukemia Ph Positive
Eligibility:
All Genders
Up to 55 years
Phase:
PHASE4
Brief Summary
20-25% of patients over 15 years with acute lymphoblastic leukemia (ALL) have the Philadelphia chromosome or BCR-ABL rearrangement. Traditionally, intensive chemotherapy followed by hematopoietic stem...
Detailed Description
Induction Chemotherapy * Vincristine (VCR): 1.5 mg/m2 (maximum dose 2 mg) iv days 1, 8, 15 and 22 * daunorubicin (DNR) 45 mg/m2 i.v. days 1, 8, 15 and 22 * Prednisone (PDN): 60 mg/m2 per day, i.v. or...
Eligibility Criteria
Inclusion
- Patients with Ph (BCR/ABL) positive de novo \< 55 years old (it is advisable to include patients over 55 years LAL07OPH protocol).
- Performance status 0-2 (Appendix B) may include patients with performance status \> 2 attributable to LAL.
- Patients without functional impairment of organs: liver function: total bilirubin, AST, ALT, alfa-GT and alkaline phosphatase less than 3 times the upper limit of normal laboratory renal function: serum creatinine \< 2 mg/dL or clearance creatinine \> 30 ml/min (except renal function attributable to LAL) cardiac function (Appendix B) normal: ventricular EF \> 50%, absence of severe chronic respiratory disease. In the event that alterations are secondary to the disease is at the discretion of the investigator to determine if the patient can be included in the trial.
Exclusion
- Any other variety of LAL
- Patients with a history of coronary artery disease, valvular or hypertensive heart disease
- Patients with chronic liver disease
- Patients with chronic respiratory failure
- Renal failure not due to LAL
- Patients with positive HIV status
- No serious neurological abnormalities due to LAL
- Impact on overall severe (grade 3 or 4 of the WHO scale) not attributable to the LAL
- Pregnant or breastfeeding
- initial blast crisis CML
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01491763
Start Date
January 1 2008
End Date
December 1 2022
Last Update
January 19 2022
Active Locations (81)
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1
H. Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
2
Hospital Germans Trias i Pujol and all Hospital Pethema
Badalona, Barcelona, Spain
3
Hospital de Mataró
Mataró, Barcelona, Spain
4
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain