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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT01097057
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of CD20+ non-Hodgkin's lymphoma
* Left ventricular ejection fraction at rest \>= 50% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram
* Bilirubin =\< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 times the upper limit of normal
* Creatinine clearance (calculated creatinine clearance is permitted) \> 50 mL/min
* Signed informed consent
* Planned autologous transplant within 3 months after collection of peripheral blood stem cells (PBSCs)
Exclusion Criteria:
* Karnofsky performance score \< 70%
* Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
* Prior other malignancies except resected basal cell carcinoma or treated cervical carcinoma or breast cancer in situ; cancer treated with curative intent \> 5 years previously will be allowed
* Pregnant or breastfeeding
* Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization
* Prior autologous or allogeneic hematopoietic stem cell transplant (HSCT)
* Human immunodeficiency virus (HIV) positive
* Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
* Hepatitis B carriers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01097057
Study Brief:
Protocol Section:
NCT01097057