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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT00873457
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of CLL or SLL based on iwCLL diagnostic criteria.
* Prior therapy for CLL (no limit on number of prior regimens).
* Patients requiring therapy, based on at least one of the iwCLL criteria.
* 18 years of age or older.
* Performance status ECOG 0, 1, or 2.
* An estimated or measured creatinine clearance ≥30 ml/min at study enrollment.
* AST, ALT, and total bilirubin ≤ 2.5 times the upper limit of normal, unless due to CLL/SLL.
* Female subject who is either post-menopausal or surgically sterilized or male or female subject willing to use an acceptable method of birth control for the duration of the study therapy and for 2 weeks after study therapy completion.
Exclusion Criteria:
* Female subject is pregnant or lactating.
* Patient has received other investigational drugs for this disease within 14 days of enrollment.
* Patient with known HIV prior to enrollment.
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Patients with another malignancy within the last three years (from documentation of remission) other than basal or squamous cell skin cancer or CIS of the cervix or early stage prostate cancer not requiring systemic treatment.
* Patients who underwent allogeneic stem cell transplant and have at least 2% donor cells engrafted will be excluded.
* Significant cardiac or vascular events within 6 months: acute MI, unstable angina, severe peripheral vascular disease (ischemic pain at rest class 3 or worse, non-healing ulcers/wounds, congestive heart failure (NHYA class ≥ 2), uncontrolled cardiac arrhythmias.
* Known severe hypersensitivity to perifosine or any component of the formulation.
* Life expectancy less than six months due to co-morbid illness
* Active autoimmune hemolytic anemia or immune thrombocytopenia, requiring current steroid therapy.
* De novo prolymphocytic leukemia (PLL) or PLL arising from CLL (≥ 55% prolymphocytes).
* Richter's transformation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00873457
Study Brief:
Protocol Section:
NCT00873457