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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT01670812
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-80 years old.
2. Diagnosis of chronic lymphocytic leukemia.
3. Active disease meeting at least one of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment.
4. Ultra-high risk CLL(Meets at least one of the following criteria) (1)ultra high-risk genetics (17p deletion and/or TP53 mutation) (2)short PFS(\<24 months)after intense immunochemotherapy treatment(i.e. FCR, FR, PCR, BR etc) (3)fludarabine-refractory
5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria:
1. Severe allergic constitution or asthma.
2. Recent myocardial infarction or hypotension.
3. ECOG performance status of ≤ 2 at study entry.
4. Active hepatitis B(DNA \>1×103/ml)
5. Severe and uncontrolled diabetes mellitus.
6. Severe and uncontrolled hypertension(BP\> 150/90 mmHg after treatment).
7. Active and uncontrolled systematic infection which need treatment of antibiotics.
8. Clinical symptoms of dysfunction of central nervous system.
9. Unstable and severe gastrorrhagia and peptic ulcer.
10. Major surgery within three weeks.
11. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
12. In any conditions which investigator considered ineligible for this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01670812
Study Brief:
Protocol Section:
NCT01670812