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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT01423032
Eligibility Criteria:
Inclusion Criteria:
* histologically or immunologically confirmed chronic B-cell leukemia
* refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen
* disease stage II-IV according to Rai or B/C according to Binet staging system, respectively
* Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better
* negative pregnancy test/ adequate method of contraception
Exclusion Criteria:
* T-CLL, PLL (prolymphocytic leukemia)
* presence of Richter's transformation
* first-line treatment containing either fludarabine or bendamustine
* acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin \> 5mg/dl), renal system (creatinine \> 2 mg/dl), or metabolic disorders
* secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01423032
Study Brief:
Protocol Section:
NCT01423032