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 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT00169195
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with histologically or cytologically proven, CD 20+, diffuse large B-cell lymphoma,
* Relapse after first or second CR, PR or less than PR to first-line treatment for the rituximab-naïve patients, OR relapse after first or second CR with a minimum delay of 12 months between the last rituximab infusion and the inclusion for the rituximab-experienced patients
* Aged 18 - 75 years
* Not eligible for autologous transplantation
* Previously treated with chemotherapy containing anthracycline, with or without rituximab
* ECOG performance status 0 to 2
* With a minimum life expectancy of 3 months
* Having signed informed consent form prior to enrollment
Exclusion Criteria:
* Burkitt's, mantle cell, T-cell lymphomas
* CD 20-negative lymphoma
* HIV or HBV related disease
* Central nervous system or meningeal involvement by the lymphoma
* Not previously treated with anthracycline-containing regimens
* Contraindication to any drug contained in the R-GEMOX chemotherapy regimen
* Any serious active disease or co-morbid medical condition (according to the investigator's decision),
* Poor renal function (creatinine level \> 150micromol/l), poor hepatic function (total bilirubin level \> 30mmol/l, transaminases \> 2.5 maximum normal level) unless these abnormalities are related to the lymphoma
* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l, unless related to bone marrow infiltration
* Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
* Any radiotherapy during the four weeks before inclusion
* Pregnant or lactating woman
* Adult patient unable to give informed consent because of intellectual impairment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00169195
Study Brief:
Protocol Section:
NCT00169195