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 @ 1:55 PM
Ignite Modification Date:
2025-12-24 @ 1:55 PM
NCT ID:
NCT00180895
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically proven B-cell malignancies, either Burkitt NHL or L3 ALL or large B-cell lymphoma or aggressive B-cell NHL, with the exception of diffuse large B-cell lymphoma arising in the mediastinum.
* Immunohistochemistry showing CD20 positivity
* Measurable (at least one bi-dimensionally measurable lesion) or evaluable (bone marrow, bone involvement) disease in progression since the last evaluation
* First relapsed or refractory disease after LMB or BFM protocol, except the isolated CNS relapses
* Life expectancy \> 4 weeks
* Performance status (Karnofsky) \> 30
* Adequate hepatic, renal and cardiac functions
* Wash out of 3 weeks in case of recent chemotherapy
* Complete initial work-up within 8 days prior to treatment
* Able to comply with scheduled follow-up and with management of toxicity
* Written inform consent form from adult patients and from parents and legal guardians for minor children
Exclusion Criteria:
* Active viral infection, especially chronic hepatitis B
* previous salvage therapy for relapse
* Prior or current history of severe allergy
* Primary large B-cell lymphoma of the mediastinum
* Isolated CNS relapse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
20 Years
Study:
NCT00180895
Study Brief:
Protocol Section:
NCT00180895