Clinical trial NCT00866203: HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: High-Grade Lymphomas
Lead sponsor: Gruppo Italiano Studio Linfomi
Sponsor class: OTHER
First posted: 2009-03-20
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: remission duration
timeFrame: end of treatment
measure: overall survival
timeFrame: study end
measure: event-free survival
timeFrame: study end
measure: freedom-from progression
timeFrame: study end
Secondary outcomes:
measure: feasibility and toxicity
timeFrame: end of treatment
Other outcomes:
Locations:
city: Modena
country: Italy
facility: GISL Trial Office
Study officials:
affiliation: GISL
name: Nicola Di Renzo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GISL
name: Massimo Federico, MD
role: STUDY_CHAIR
affiliation: GISL
name: Maura Brugiatelli, MD
role: STUDY_CHAIR
affiliation: GISL
name: Mario Petrini, MD
role: STUDY_CHAIR
affiliation: GISL
name: Paolo G Gobbi, MD
role: STUDY_CHAIR
References: