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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00963534
Eligibility Criteria:
Inclusion Criteria:
* Age over 65 years, or age under 65 years, unable to tolerate high dose chemotherapy with autologous stem cell support
* Histologically confirmed mantle cell lymphoma, stage II-IV at time of diagnosis
* No previous treatment for lymphoma except radiotherapy or one cycle of any chemotherapy regimen for lymphoma
* WHO Performance Status 0-3
* Written informed concent
* Female subjects of childbearing potential must agree to use and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, through study drug therapy and for 4 weeks after the end of study drug therapy
* Male subjects must agree to use condoms throughout study drug therapy if their partner is of childbearing potential, and has no contraception, and agree to not donate semen during study drug therapy and for one week after end of study drug therapy
* All subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation, and agree not to share study medication with another person
Exclusion Criteria:
* Impaired liver function
* ANC less than 1.0 x 10 9, unless caused by bone marrow infiltration by lymphoma
* Platelet count less than 60 x 10 9, unless caused by bone marrow infiltration by lymphoma
* Creatinine clearance below 50 ml/min (cockcroft formula))
* Known HIV positivity
* Known seropositivity for HCV, HBsAG, anti-HBc, or other active infection uncontrolled by treatment
* Psychiatric illness or condition which could interfere with the subject´s ability to understand the requirements of the study
* Requirement of corticosteroid therapy at a dose over 10 mg prednisolone/day
* Pregnant or lactating females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00963534
Study Brief:
Protocol Section:
NCT00963534