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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT00974792
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diffuse large B-cell non-Hodgkin lymphoma
* International Prognostic Index (IPI) score high-intermediate (score = 3) OR high (score = 4 or 5), defined as:
* Stage III or IV disease
* Raised lactic dehydrogenase and poor performance status (WHO performance status 2-4)
* All morphological variants included
* B-cell nature of the proliferation must be verified by a positive anti-CD20 antibody (i.e., CD20-positive disease)
* No T-cell lymphoma
* No history of treated or non-treated indolent lymphoma
* Patients newly diagnosed who have large B-cell lymphoma with some small cell infiltration in the bone marrow or lymph node may be allowed
PATIENT CHARACTERISTICS:
* See Disease Characteristics
* Life expectancy \> 3 months
* ANC \> 1,500/mm\^3\*
* Platelet count \> 100,000/mm\^3\*
* Serum creatinine \< 150 μmol/L\*
* Serum bilirubin \< 35 μmol/L\*
* AST and/or ALT \< 2.5 times upper limit of normal\* NOTE: \*Unless attributed to bone marrow infiltration by lymphoma.
* Fertile patients must use effective contraception
* Normal MUGA or echocardiogram without areas of abnormal contractility
* LVEF ≥ 50% and only tested if patient meets 1 of the following criteria:
* History of diabetes
* Prior cardiac disease, hypertension, or abnormal resting ECG
* No history of heart failure or uncontrolled angina pectoris
* No cardiac contraindication to doxorubicin hydrochloride (e.g., abnormal contractility on echocardiography or MUGA)
* No neurological contraindication to vincristine sulfate (e.g., pre-existing diabetic neuropathy)
* No concurrent uncontrolled medical condition
* No other serious active disease
* No general status that, according to the investigator, does not allow the administration of 2 courses of CODOX-M/IVAC
* No active malignant disease within the past 10 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
* No positive serology for HIV or hepatitis B or C
* No medical or psychiatric conditions that compromise the patient's ability to give informed consent
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy, radiotherapy, or other investigational drug for diffuse large B-cell non-Hodgkin lymphoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00974792
Study Brief:
Protocol Section:
NCT00974792