Status:
COMPLETED
Glivec in Ph Positive Lymphoblastic Leukemia
Lead Sponsor:
PETHEMA Foundation
Conditions:
Acute Lymphoblastic Leukemia
Cromosome Philadelphia Positive
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00388895
Start Date
June 1 2002
End Date
October 1 2007
Last Update
November 19 2008
Active Locations (28)
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1
Hospital General de Alicante
Alicante, Alicante, Spain
2
Hospital "Duran I Reynals"
Barcelona, Barcelona, Spain
3
Hospital "Santa Creu i Sant Pau"
Barcelona, Barcelona, Spain
4
Hospital Clínico y Provincial de Barcelona
Barcelona, Barcelona, Spain