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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT00324467
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* newly diagnosed histologically proven CD-20 positive diffuse large B- cell lymphoma by tissue biopsy, listed under peripheral B-cell neoplasm according to the WHO/REAL classification (diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, T-cell rich B-cell lymphoma, intravascular large B-cell lymphoma)
* Advanced stage disease defined as - patients with stage III or stage IV disease; or patients with stage I or stage II disease with one of the following additional criteria: B-symptoms, or disease that is not radio- encompassable within a single involved field, or not a candidate for brief chemotherapy and irradiation, or the presence of bulky disease (any single mass =\> 10 cm)
* Previously untreated or treated with up to 3 cycles of standard dose 3- weekly R-CHOP chemotherapy prior to enrollment (i.e. patients may be enrolled prior to initiation of the fourth cycle of R-CHOP chemotherapy)
* ECOG Performance Status 0,1 or 2 at time of enrollment
* No evidence of progressive disease while on R-CHOP chemotherapy
* The patient must sign the consent form prior to registration
Exclusion Criteria:
* Patients with a history of any other lymphoproliferative disorder, including prior history of indolent NHL
* Patients with a history of prior or concurrent malignancies within 5 years of the current diagnosis, except adequately treated non- melanoma skin cancer, and curatively treated in-situ cancer of the cervix
* Known HIV infection
* Known hepatitis B virus infection
* Pregnancy or lactation. Men and women of childbearing age must be using adequate contraception.
* Significant renal insufficiency (serum creatinine \> 200 mmol/L), unless due to lymphoma
* Significant hepatic insufficiency (serum total bilirubin \> 30 mmol/L), unless due to lymphoma
* Cardiac contraindication to doxorubicin therapy (e.g. abnormal contractility on echocardiography). If history of cardiac disease, ejection fraction must be within normal limits for age.
* Neurologic contraindication to vincristine (e.g. peripheral neuropathy)
* Absolute neutrophil count \<1.5 x 109/L (unless due to bone marrow involvement with lymphoma or due to initiation of R-CHOP chemotherapy)
* Platelet count \< 100 x 109/L (unless due to splenomegaly, bone marrow involvement with lymphoma or due to initiation of R-CHOP chemotherapy)
* Evidence of active systemic infection
* Any medical condition that in the opinion of the investigator would compromise treatment delivery, add toxicity or impair assessment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00324467
Study Brief:
Protocol Section:
NCT00324467