Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT00388895
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
65 Years
Study:
NCT00388895
Study Brief:
Protocol Section:
NCT00388895