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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT00866203
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed, untreated patients with histologically documented aggressive lymphoma;
* Age between 18 and 65 years;
* Clinical stage at diagnosis: I A bulky - IV B;
* Reduction of tumoral masses, after four courses of induction therapy, between 50 and 75%;
* Serum negativity for HIV, HbsAg and HCV;
* ECOG performance status 0 through 4;
* Adequate bone marrow function;
* Adequate renal and hepatic functions;
* Left ventricular ejection fraction (LVEF) \> 50%;
* No previous malignant disease;
* No previous chemo-radiotherapy;
* No cerebral or CNS involvement, assessed by clinical history, physical examination and CSF examination through lumbar puncture;
* Written informed consent given at time of randomization.
Exclusion Criteria:
* Clinical stage I no bulky, or CS IIA-B with less than three sites of disease involved;
* Patients with CR, unconfirmed complete remission (uCR), very good PR (\>75%) and clinical response less than 50%, as defined by Cheson et al., following four courses of induction therapy;
* Tumor involvement of CNS (except patients with peridural masses without liquor involvement , who can be enrolled in this study);
* Indolent lymphoma transformed in more aggressive histologic type, even if never previously treated;
* Aggressive non-Hodgkin's lymphoma in pre-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;
* Left ventricular ejection fraction (LVEF) \< 50%;
* Evidence of any severe active acute or chronic infection;
* Concurrent malignancy of history of other malignancy, except basal cell carcinoma of the skin (BCC) and in situ cervical carcinoma (CIN);
* myelodisplastic syndrome;
* HbsAg, HIV-positive, or HCV-RNA-positive patients;
* Patient with psychiatric, or any disorder that compromises ability to give truly informed consent for participation in this study;
* Pregnant woman; potential child-bearing women can be enrolled if adequate contraceptive precautions are used before entering this trial and for the duration of the trial;
* Concerns for patient's compliance with the protocol procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00866203
Study Brief:
Protocol Section:
NCT00866203