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 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT02099292
Eligibility Criteria:
Inclusion Criteria:
* age between 18 and 65 years
* Patients with aggressive B-cell-lymphoma:diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or grade IIIB follicular lymphoma (FL) with relapse after complete remission (CR) or failure to achieve CR on treatment.
* Patients with indolent lymphoma: FL grade I-IIIA, marginal zone lymphoma (MZL) and immunocytoma (IC) if relapsed or failure to achieve at least partial remission (PR) on treatment.
* CD20 positive
* previous therapy: at least 3 cycles of anthracycline containing regimens.
* ECOG (Eastern Cooperative Oncology Group) 0-2
* measurable disease
* adequate bone marrow function (absolute neutrophil count \[ANC\] \>1500/µl; platelet count \>100,000/µl), unless there was clear evidence of bone marrow involvement
* glomerular filtration rate \> 60ml/min
* ASAT(aspartate transaminase)/ALAT(alanine aminotransferase) \< 2.5-fold upper limit of normal (ULN) unless associated with liver infiltration
* free from other cancers for at least 5 years, with the exception of basal cell carcinoma and carcinoma in situ of the uterine cervix.
* given informed consent
Exclusion Criteria:
* (central nervous system) CNS-lymphoma
* HIV
* Hepatitis B or C
* pregnancy
* breast-feeding women
* high dose therapy or allogeneic transplantation
* glomerular filtration rate \< 60ml/min
* ASAT/ALAT \> 2.5-fold upper limit of normal (ULN) unless associated with liver infiltration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02099292
Study Brief:
Protocol Section:
NCT02099292