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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT01456351
Eligibility Criteria:
Inclusion Criteria:
* Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:
* Follicular lymphoma grade 1 and 2
* Immunocytoma and lymphoplasmocytic lymphoma
* Marginal zone lymphoma, nodal and generalised
* Mantle cell lymphoma
* lymphocytic lymphoma (CLL without leucaemic characteristics)
* non-specified/classified lymphomas of low malignancy
* Recurrent disease (remission duration minimum 3 months), independent of type or quantity of prior therapies, except of Rituximab containing regimens, or if remission duration is \> 1 year after Rituximab containing regimen, or refractory to prior therapy (progression under therapy or during 3 months after completion), except refractory disease to purin analogs or Bendamustine
* Need for therapy, except mantle cell lymphomas
* Stadium II (bulky disease, 7.5 cm), II or IV
* Written informed consent
* Performance status WHO 0-2
* Histology not older than 6 months
Exclusion Criteria:
* Patients not establishing all above mentioned prerequisites
* Option of a primary, potentially curative radiation therapy
* Patients refractory to Rituximab containing regimens
* Comorbidities excluding a study conform therapy:
heart attack during the last 6 months severe, medicinal not adjustable hypertonia severe functional defects of the heart (NYHA III or IV) lung (WHO grade III or IV) liver or kidney (creatinine \> 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma
* Active auto immunohemolytic anemia (AIHA)
* HIV positive patients
* Active hepatitis infection
* Severe psychiatric diseases
* No compliance or non-compliance to be expected
* Pregnant or breast feeding women
* Anamnestic malignancies or secondary malignancies, not proven
* Cured/curable by surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01456351
Study Brief:
Protocol Section:
NCT01456351