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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT00033267
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed mantle cell non-Hodgkin's lymphoma (MCL)
* Relapsed, refractory, or stable disease after prior chemotherapy, radiotherapy, or immunotherapy
* Unidimensionally measurable lymph node or lesion
* At least 2.0 cm by CT scan or MRI OR at least 1.5 cm by physical exam
* One of the following measurement parameters may be used:
* Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin
* Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm\^3
* No known CNS involvement (parenchymal mass or leptomeningeal involvement)
* Performance status - ECOG 0-2
* At least 3 months
* See Disease Characteristics
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 8 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Direct bilirubin ≤ 1.5 times ULN
* AST ≤ 3 times ULN (5 times ULN if liver metastases are present)
* Creatinine ≤ 2 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Cholesterol ≤ 350 mg/dL
* Triglycerides ≤ 400 mg/dL
* HIV negative
* No other active malignancy requiring treatment or that would preclude study participation
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* See Disease Characteristics
* Prior high-dose therapy with stem cell transplantation allowed
* At least 7 days since prior immunotherapy or other non-myelosuppressive biologic response modifiers
* See Disease Characteristics
* See Biologic therapy
* At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No other concurrent chemotherapy for MCL
* Concurrent corticosteroids for adrenal insufficiency allowed
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy
* No concurrent radiotherapy for MCL
* Any number of prior treatments allowed
* No other concurrent investigational or commercial agents for MCL
* No concurrent drugs that induce cytochrome p450 (e.g., carbamazepine, phenobarbital, phenytoin, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide)
* No concurrent immunosuppressive therapies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00033267
Study Brief:
Protocol Section:
NCT00033267