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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT00244127
Eligibility Criteria:
Inclusion Criteria:
* Diffuse Large B-Cell Lymphoma (DLBCL), and their morphologic variants and subtypes, i.e. Centroblastic lymphoma, Immunoblastic lymphoma, T-cell rich/B-cell lymphoma, anaplastic large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma;
* Primary diffuse large B-cell lymphoma of MALT (incorrectly defined as high-grade MALT lymphoma);
* Marginal zone B-cell lymphoma with coexisting areas of DLBCL;
* Age of ≥60 years;
* Clinical stage at diagnosis: I A bulky - IV B;
* CD20 positivity;
* Serum negativity for HbsAg and HCV except for those with no sign of active viral replication, assessed by HCV-RNA copies;
* Absolute neutrophil count (ANC) ≥1.5x109/L, and platelet count ≥100x109/L (unless both are attributed directly to bone marrow involvement by lymphoma or auto-immune disease secondary to lymphoma);
* Serum creatinine ≤130μM/L, serum bilirubin ≤2.5xULN aspartate amino-transferase (AST/GOT), ≤2.5xULN alanine amino-transferase (ALT/GPT) ≤2.5xULN, and alkaline phosphatase ≤4 times the upper limit of normal (unless the increase is attributed directly to the presence of tumour by the Investigator)
* Left ventricular ejection fraction (LVEF) ≥50%;
* ECOG performance status 0-2;
* At least one measurable lesion is mandatory;
* Written informed consent given at time of registration;
* Males and females (both males and females of childbearing potential must agree to use adequate contraception for the duration, and for 3 months after the completion, of the treatment).
Exclusion Criteria:
* Clinical stage I non-bulky, or CS IIA with less than three sites of disease involved (patients with stage IIB are eligible, regardless of the number of sites involved);
* Tumour involvement of CNS;
* Indolent lymphoma transformed in more aggressive histological type, even if never previously treated;
* Mantle Cell Lymphoma, Peripheral T cell Lymphoma and their variants;
* Aggressive non-Hodgkin's lymphoma in transplanted patient;
* Clinically significant secondary cardiovascular disease, e.g. uncontrolled hypertension, (resting diastolic blood pressure \>115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV;
* Evidence of any severe active acute or chronic infection;
* Concurrent malignancy or history of other malignancy, except basal cell carcinoma of the skin (BCC) and in-situ cervical carcinoma (CIN) / Myelodysplastic syndrome;
* HbsAg, HIV-positive, or HCV-RNA-positive patients;
* Inability to comply with study procedures;
* Prior CNS lymphoma;
* Prior radiation to non-CNS lymphoma mass(es) as a treatment for lymphomas;
* History of allergic reaction to anthracyclines, eggs, and egg products or known sensitivities, or history of unusual reaction, to other components of, or treatments similar to, the investigational treatment regimen;
* Presence of other medication that may interfere with study treatment or the action of the investigational product or confuse the assessment of study results
* Pregnant women or nursing mothers;
* Participation in an investigational drug study within 4 weeks prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00244127
Study Brief:
Protocol Section:
NCT00244127