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 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 12:11 AM
NCT ID:
NCT00466258
Eligibility Criteria:
Inclusion Criteria:
* Patients with HIV infection diagnosed with DLBCL in any stage (I-IV according to the Ann Arbor classification) not previously treated for the lymphoma.
* Patients with CD20-positive diffuse large B-cell lymphoma
* Aged from 18 to 70 years old
* Any score of International Prognostic Index. (It is also applicable in patients with non-Hodgkin lymphoma \[NHL\] infected with HIV.)
* ECOG performance status 0 to 3
* Written informed consent
* Absolute neutrophil count \> 1.5 x 10\^9/L.
* Absence of synchronic or non-synchronic neoplasia with the exception of non-melanoma skin tumors or in situ cervical carcinoma.
* CD4+ lymphocyte count \> 100/µL
Exclusion Criteria:
* Patients with diffuse large B cell lymphoma previously treated.
* Patients with primary central nervous system lymphoma.
* Patients with Burkitt or Burkitt-like NHL.
* CD4+ lymphocyte count \< 100/µL
* Opportunistic infections or other AIDS-related neoplasias in activity.
* Active drug-addiction.
* Pregnant or lactating women or adults of fertile age who do not use an effective contraceptive method.
* Patients with serious altered renal function (creatinine \> 2.5 x upper limit of normal \[ULN\]) or hepatic \[bilirubin, ALT or AST \> 2.5 x ULN\], except if the investigators suspect that they are caused by the disease.
* Cardiac insufficiency with ejection fraction \< 40%
* Patients with serious psychiatric diseases that can interfere with their capacity to understand the study (including alcoholism or active drug-addiction).
* ECOG \> 3
* Patients with a known hypersensitivity to murine proteins or any other component of the study drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00466258
Study Brief:
Protocol Section:
NCT00466258