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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT01144403
Eligibility Criteria:
Inclusion Criteria:
* adult participants, \>/=18 years of age
* untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation
* known mantle cell lymphoma international prognostic index (MIPI) at diagnosis
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* adequate hematological, renal and hepatic function
Exclusion Criteria:
* known hypersensitivity to murine proteins or chemotherapy regimen
* previous first-line therapy
* history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
* active infection
* clinically significant cardiac disease
* regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01144403
Study Brief:
Protocol Section:
NCT01144403