A Prospective, Randomized, Multicenter Trial Comparing a Modified HDS Therapy Supported by PBPC Transplant With Additional 4 Courses of Front-Line Therapy in Adult Aggressive NHL With PR After Short Course of Up-Front Chemotherapy
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.