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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT00776802
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients who are 18 years of age or older with diffuse large B-cell cell lymphoma (DLBCL) relapsed or refractory after initial therapy who:
* Are not candidates for autologous stem cell transplant.
* Have relapsed after autologous or allogeneic stem cell transplant.
* Have relapsed or refractory disease after 3 successive chemotherapy regimens.
* ECOG Performance Score 0-2
* Creatinine clearance \> 60 mL/min/1.73 m2.
* Total bilirubin ≤2.0 X Institutional Upper Limit of Normal (IULN)
* AST (SGOT)/ALT (SGPT) ≤2.5 X IUNL, or ≤5X IUNL in patients with liver involvement of DLBCL
* Absolute neutrophil count \>1,000 /\_L; hemoglobin \>9 g/mL; platelet count \> 75,000 /\_L at screening.
* Patients must be capable of understanding the purpose and risks of the study and able to provide written consent.
* Patients must be willing and able to comply with the prescribed treatment protocol and evaluations
Exclusion Criteria:
* Treatment with experimental (unlicensed) drug within 3 weeks of treatment.
* Previous chemotherapy, or major surgery within 21 days prior to first study treatment, or radiation therapy within 6 weeks.
* Rapidly progressive disease or organ function threatened by disease
* Serious, uncontrolled active infections.
* Serologically positive for HIV, HBV, or HCV.
* Clinically significant cardiac, pulmonary, and/or hepatic dysfunction
* Lymphoma involving the central nervous system
* Female patients who are pregnant or breast feeding.
* Patients not capable of understanding the purpose and risks of the study and or unable to provide written consent.
* Patients not willing and or unable to comply with the prescribed treatment protocol and evaluations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00776802
Study Brief:
Protocol Section:
NCT00776802