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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT00109967
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed\* mantle cell lymphoma (MCL)
* Relapsed, refractory, or stable disease after prior treatment
* Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by fluorescent in situ hybridization or cytogenetics
* Measurable disease, defined as ≥ 1 of the following:
* Unidimensionally measurable lymph node or tumor mass ≥ 2 cm by CT scan or MRI
* Splenic enlargement if spleen is palpable ≥ 3 cm below the left costal margin
* Malignant lymphocytosis if absolute lymphocytic count ≥ 5,000 AND lymphocytes confirmed to be monoclonal by flow cytometry
* No known central nervous system involvement (e.g., parenchymal mass or leptomeningeal involvement)
* Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
* At least 3 months
* No other concurrent treatment for MCL
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Direct bilirubin \< 1.5 times ULN
* Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver involvement by MCL is present)
* Creatinine ≤ 2 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* Cholesterol ≤ 350 mg/dL
* Fasting triglycerides \< 400 mg/dL
* No known HIV positivity
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No other active malignancy requiring treatment OR that would preclude assessment of response to study drugs
* Prior biologic response modifiers allowed
* Prior immunotherapy allowed
* Prior high-dose therapy with stem cell support (i.e., stem cell transplantation) allowed
* No concurrent prophylactic growth factor to support neutrophils
* Prior chemotherapy allowed
* No other concurrent chemotherapy
* No concurrent corticosteroids to induce an antitumor response
* Concurrent corticosteroids (≤ 10 mg/day of prednisone or equivalent) for adrenal insufficiency or acute allergic reactions allowed
* Prior radiotherapy allowed
* No prior treatment with a mammalian target of rapamycin (mTOR) inhibitor
* No other concurrent investigational or commercial agents or therapies for MCL
* No other concurrent immunosuppressive therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00109967
Study Brief:
Protocol Section:
NCT00109967