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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00875667
Eligibility Criteria:
Inclusion Criteria:
* Biopsy proven mantle cell lymphoma
* Patients who are refractory to their regimen or have relapsed once, twice or up to three times and who have documented progressive disease
* Eastern Cooperative Oncology Group (ECOG) performance score 0,1, or 2
* Willing to follow pregnancy precaution
Exclusion Criteria:
* Any of the following laboratory abnormalities
* Absolute neutrophil count (ANC) \< 1,500 cells/mm\^3 (1.5 x 10\^9/L)
* Platelet count \< 60,000/mm\^3 (60 x 10\^9/L)
* Serum aspartate transaminase/serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) \>3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
* Serum total bilirubin \> 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
* Calculated creatinine clearance (Cockcroft-Gault formula) of \< 30 mL/min
* History of active central nervous system (CNS) lymphoma within the previous 3 months
* Subjects not willing to take deep venous thrombosis (DVT) prophylaxis
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00875667
Study Brief:
Protocol Section:
NCT00875667