Status:
COMPLETED
HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy
Lead Sponsor:
Gruppo Italiano Studio Linfomi
Conditions:
High-Grade Lymphomas
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The study is planned to compare the outcome of aggressive NHL patients in partial remission after four courses of front-line therapy, randomly assigned to receive either additional four courses of the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT00866203
Start Date
October 1 2000
End Date
April 1 2008
Last Update
March 20 2009
Active Locations (1)
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1
GISL Trial Office
Modena, Italy, 41100