NCT00866203CompletedPhase 3
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
Gruppo Italiano Studio Linfomi1 site in 1 country441 target enrollmentStarted: October 2000Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 441
- Locations
- 1
- Primary Endpoint
- remission duration
Study Overview
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 same regimen or a modified HDS program.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
HDS
Experimental
modified high dose sequential therapy
Intervention: HDS vs ProMECE/CytaBOM (Drug)
ProMECE/CytaBOM
Active Comparator
four additional courses of standard ProMECE/CytaBOM
Intervention: HDS vs ProMECE/CytaBOM (Drug)
Outcomes
Primary Outcomes
remission duration
Time Frame: end of treatment
overall survival
Time Frame: study end
event-free survival
Time Frame: study end
freedom-from progression
Time Frame: study end
Secondary Outcomes
- feasibility and toxicity(end of treatment)
Investigators
Study Sites (1)
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