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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT01439750
Eligibility Criteria:
Inclusion Criteria:
* Females that are postmenopausal for at least 1 year before the screening visit, surgically sterilized or if they are of childbearing potential agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose.
* Male subjects must agree to practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
* Patients with newly diagnosed and relapsed mantle cell lymphoma.
* ECOG performance status grade 3 or higher.
Exclusion Criteria:
* Patient has a platelet count of \<50x10 9/L within 14 days before enrollment if not related to disease.
* Patient has an absolute neutrophil count less than 100 within 14 days before enrollment if not related to disease.
* Patient has a calculated or measured creatinine clearance of \<20 mL/minute within 14 days before enrollment.
* Patient has \> Grade 2 peripheral neuropathy within 14 days before enrollment.
* Patient has \> 1.5 x ULN total bilirubin.
* Myocardial infarction within 6 months prior to enrollment or has New York Heart Association Class II or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* Patient has hypersensitivity to bortezomib, boron or mannitol.
* Female subject is pregnant or breast-feeding.
* Patient has received other investigational drugs within 14 days before enrollment.
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01439750
Study Brief:
Protocol Section:
NCT01439750