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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT00295932
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Chronic lymphocytic leukemia (CLL)
* B-cell small lymphocytic leukemia (SLL)
* Any marginal zone lymphoma
* Grade 1-3A follicular lymphoma
* Waldenstrom's macroglobulinemia
* Mantle cell lymphoma
* No transformed indolent lymphoma
* Assessable disease (phase I)
* Measurable disease (phase I and II), defined as ≥ one lesion that can be accurately measured in ≥ 1 dimension as ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan
* Lymph nodes measuring ≤ 1 cm in the short axis are considered normal
* Relapsed or refractory disease
* Must have received at least 1 prior therapeutic regimen but no more than 3 prior conventional cytotoxic therapy regimens
* No known brain metastases or meningeal disease
PATIENT CHARACTERISTICS:
* Karnofsky performance status \> 50%
* Absolute neutrophil count \> 1,000/mcl (more than 500/mcl if known lymphomatous involvement)
* Platelet count ≥ 50,000/mcl
* Total bilirubin \< 1.5 times upper limit of normal (ULN) (less than 5 mg/dL if known history of Gilbert's disease)
* AST and ALT ≤ 2.5 times ULN (4 times ULN if liver involvement)
* Creatinine \< 1.5 times ULN OR creatinine clearance \> 50 mL/min
* Patients may have febrile episodes up to 38.5ºC without evidence of active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No New York Heart Association class III or IV congestive heart failure
* No uncontrolled intercurrent illness, including any of the following:
* Ongoing or active infection
* Cerebrovascular accident or transient ischemic attack within 6 months of study entry
* Unstable angina pectoris
* Cardiac arrhythmia
* EKG evidence of acute ischemia
* Psychiatric illness/social situations that would limit compliance with study requirements
* No uncontrolled hypertension requiring active manipulation of antihypertensive medications
* No known or active HIV infection
* No history of hypersensitivity to bortezomib, boron, or mannitol
* No peripheral neuropathy \> grade 2
* No other malignancy within the past 5 years except curatively treated non life-threatening malignancies, such as cutaneous basal cell or squamous cell carcinoma or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* Prior stem cell transplantation allowed
* Preparative cytoreductive and high-dose therapies considered 1 prior therapy
* At least 4 weeks since prior cytotoxic chemotherapy (6 weeks since prior nitrosoureas or mitomycin C)
* At least 12 weeks since prior radioimmunotherapy
* One prior course comprising tositumomab or ibritumomab tiuxetan allowed
* At least 1 week since prior palliative steroids for NHL
* No therapeutic monoclonal antibodies (e.g., rituximab, tositumomab, ibritumomab, alemtuzumab, etc.) within 3 months of study entry
* Patients treated with monoclonal antibodies within 3 months allowed provided disease progressed on this therapy AND no treatment received 7 days prior to study entry
* Seven days since prior rituximab (for patients enrolled in phase I portion)
* No major surgery within 4 weeks of study entry
* No other concurrent investigational agents
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00295932
Study Brief:
Protocol Section:
NCT00295932