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:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT00464633
Eligibility Criteria:
Inclusion Criteria:
* Patient must have documentation of histologically confirmed and measurable Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) arising from CLL;
* Patient must have symptomatic and progressive disease;
* Patient must have received prior alkylating agent(s) and be fludarabine refractory;
* Patient must have the adequate organ functions;
* Patient's Eastern Cooperative Oncology Group performance (ECOG) status must be 0-2;
Exclusion Criteria:
* Patient with de novo PLL;
* Patient with secondary malignancy that will limit survival ≤5 years;
* Patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months;
* Patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry;
* Patient with known history of glucose-6-phosphate dehydrogenase deficiency;
* Patient with autoimmune hemolytic anemia;
* Patient with known Central Nervous System involvement;
* Patient with active, uncontrolled serious bacterial, viral or fungal infections
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00464633
Study Brief:
Protocol Section:
NCT00464633