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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT00169468
Eligibility Criteria:
Inclusion Criteria:
• Patients with one of the following B-cell Lymphoma CD 20 positive : Mantle cell, Marginal zone, lymphocytic, follicular requiring treatment, Histological transformation from low grade to high grade, diffuse large cell without adverse prognostic factors defined by the international prognostic index (IPI)
* Aged from 18 to 80 years
* Untreated with chemotherapy except with Chlorambucil or Cyclophosphamide per os alone less than 6 months
* Previous radiotherapy except if localized
* Performance status \< 3
* Signed inform consent
Exclusion Criteria:
* Other type of lymphomas: Burkitt, T cell, CD 20 negative
* Central nervous system or meningeal involvement
* Contraindication to any drug contained in the chemotherapy regimen
* HIV disease, active hepatitis B or C
* Treatment with polychemotherapy before except with Chlorambucil or Cyclophosphamide per os less than 6 months
* Prior extended radiotherapy
* Any serious active disease or co-morbid medical condition (according to investigator's decision )
* Renal deficiency (clearance \< 30 ml/mn), liver deficiency (bilirubin \> 30 mmol/l) unless related to lymphoma
* Neuropathy\> grade 2 within 14 days before enrollment
* Platelets \< 30.109/l within 14 days before enrollment
* Neutrophils \< 1.0 109/l within 14 days before enrollment
* Women with pregnancy or without adequate method of contraception
* Any history of active cancer during the last two years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00169468
Study Brief:
Protocol Section:
NCT00169468