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 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT00939328
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically and immunophenotypically confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)
* Progressive or symptomatic disease
* Purine analog-refractory disease
* Must meet 1 of the following criteria:
* Intermediate- or high-risk modified-Rai stage
* Low-risk modified-Rai stage and progressive lymphocytosis, defined as \> 50% increase of absolute peripheral lymphocyte count over the lowest count during the past 2 months
* Received 1 or more prior therapies for CLL
* Must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients"
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-3
* ANC \> 1,000/mm³
* Platelet count \> 50,000/mm³
* Serum creatinine ≤ 2 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No systemic fungal, bacterial, viral, or other infection that is not controlled (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
* No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 5 years
* HIV positivity allowed provided the following criteria are met:
* CD4 cells \> 350/mm³
* No concurrent antiretroviral therapy
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 28 days since prior chemotherapy, any other investigational agents, or major surgery
* More than 120 days since prior allogeneic or autologous hematopoietic stem cell transplantation
* If prior allogeneic bone marrow transplantation, must meet the following criteria:
* Performed \> 120 days ago
* No acute graft-vs-host disease (GVHD) ≥ grade 2
* Receiving no immunosuppressive therapy for chronic GVHD
* No concurrent antiretroviral therapy for HIV-positive patients
* No concurrent CYP1A2 inhibitors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00939328
Study Brief:
Protocol Section:
NCT00939328