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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT01325194
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 - \< 65 years. Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) based on WHO 2008 Lymphoma Classification
* Follicular lymphomas (FLs) grade 3b is allowed
Patients in at least stage II with age adjusted international prognostic score (IPI score) of 2 or 3:
* Stage III /IV and elevated LDH
* Stage III/IV and WHO performance status 2 - 3
* Stage II and elevated LDH and WHO performance status 2 - 3 And/or patients with
* More than one extranodal site
* Testicular lymphoma, stage IIE and higher
* Paranasal sinus and orbital lymphoma with destruction of bone
* Large cell infiltration of the bone marrow
Exclusion Criteria:
* Severe cardiac disease: cardiac function grade 3-4
* Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule
* Pregnancy/lactation
* Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment
* Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons
* Known HIV positivity
* Uncontrolled infectious disease, including meningeal infection
* Active cancer except basal cell carcinoma and cervical carcinoma in situ during the last five years
* Earlier treatment containing anthracyclins
* Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol
* CNS disease as diagnosed by MRI or cerebrospinal fluid (CSF) cytology. Positive CSF flow cytometry below diagnostic threshold level by cytology is allowed
* Pleural or peritoneal fluid that cannot be drained safely
* Hypersensitivity to the active substance or any of the other ingredients
* Patients participating in other clinical studies, unless followed for survival
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01325194
Study Brief:
Protocol Section:
NCT01325194