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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT00843050
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Histological diagnosis of MCL and presence of either nuclear Cyclin D1 positivity by immunohistochemistry or t(11;14) by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), or conventional karyotyping
* Documented progression or relapse after at least 1 line of prior chemotherapy
* Presence of measurable disease
* ECOG performance status 0, 1, or 2
* Life expectancy of at least 3 months
* Ability to understand and the willingness to sign a written informed consent document (ICD)
* Full recovery from all prior treatment toxicities of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1
Exclusion Criteria:
* Prior radiation therapy, chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration
* Prior treatment with monoclonal antibodies or any radio- or toxin- immunoconjugates within 3 months of study drug administration; however, a patient who has had rituximab treatment within 3 months and has had PD after such treatment is allowed in the study.
* Prior allogeneic stem cell transplantation within 1 year of study drug administration
* Current or prior CNS lymphoma
* QTc \> 450 msec
* Unstable angina, myocardial infarction, CHF or stroke within previous 6 months of study drug administration
* Presence of active and serious comorbidity and uncontrolled illness other than MCL
* History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer or early stage prostate cancer
* Hemoglobin \<8.0 gm/dL
* Absolute neutrophil count \<1000/mm3
* Platelet count \<50,000/mm3
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>3 × institutional upper limit of normal (ULN) (\> 5 × institutional ULN if liver is involved with lymphoma or if patient has Gilbert's Disease)
* Total bilirubin, \>1.5 × institutional ULN (\> 3 × institutional ULN if liver is involved with lymphoma or if patient has Gilbert's Disease)
* Serum creatinine \>1.5 × institutional ULN
* Patients known to be suffering from infection with human immunodeficiency virus (HIV), tuberculosis, Hepatitis C or Hepatitis B
* Pregnant or lactating women
* Women of childbearing potential or men not willing to use at least 2 approved methods of contraception (one of which being a barrier method) after signing the ICD, during the entire study and for at least 4 weeks following withdrawal from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00843050
Study Brief:
Protocol Section:
NCT00843050