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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT00511069
Eligibility Criteria:
Inclusion Criteria for chronic phase patients :
1. Age \>/=18 years
2. Ph positive
3. Absence of a CHR after 3 months on imatinib
4. Loss of a previously obtained CHR on imatinib alone
5. Absence of a CCgR within 12 months on imatinib alone
6. Loss of a previously obtained CCgR on imatinib alone
7. Written informed consent
Exclusion Criteria for chronic phase patients :
1. Age \<18
2. Performance status (ECOG/WHO) \> 2 (see Appendix 2)
3. Inability to provide written informed consent
4. Pregnancy
5. Accelerated or blastic phase
6. Formal refusal of any recommendation of a safe contraception
7. Alcohol or drug addiction
8. Altered hepatic or renal function as defined by AST/ALT or bilirubin \> 3 times upper normal limits (UNL)
9. Serum creatinine \> 265 umol/l or \>3.0 mg/dl
10. Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
Inclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia Ph+ patients:
1. Age \>/=18 years
2. Ph positive
3. Loss of a previous hematological response to imatinib alone, with further progression to ABP (see section 14 for definitions)
4. Performance status (ECOG/WHO)
5. Written informed consent
Exclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia Ph+ patients:
1. Age \<18
2. Performance status (ECOG/WHO) \> 2 (see Appendix 2)
3. Inability to provide written informed consent
4. Pregnancy
5. Chronic Phase disease
6. Formal refusal of any recommendation of a safe contraception
7. Alcohol or drug addiction
8. Altered hepatic or renal function as defined by AST/ALT or bilirubin \> 3 times upper normal limits (UNL)
9. Serum creatinine \> 265 umol/l or \>3.0 mg/dl
10. Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00511069
Study Brief:
Protocol Section:
NCT00511069