HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy

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

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 Overview

• Status: Completed
• Conditions: High-Grade Lymphomas
• Intervention / Treatment: Drug: HDS vs ProMECE/CytaBOM

• Study Type: Interventional
• Enrollment (Actual): 441
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41100
    • GISL Trial Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HDS; modified high dose sequential therapy	Drug: HDS vs ProMECE/CytaBOM
ACTIVE_COMPARATOR: ProMECE/CytaBOM; four additional courses of standard ProMECE/CytaBOM	Drug: HDS vs ProMECE/CytaBOM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
remission duration	end of treatment
overall survival	study end
event-free survival	study end
freedom-from progression	study end

Secondary Outcome Measures

Outcome Measure	Time Frame
feasibility and toxicity	end of treatment

Collaborators and Investigators

• Sponsor: Gruppo Italiano Studio Linfomi
• Investigators: Principal Investigator: Nicola Di Renzo, MD, GISL; Study Chair: Maura Brugiatelli, MD, GISL; Study Chair: Mario Petrini, MD, GISL; Study Chair: Paolo G Gobbi, MD, GISL

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Study Completion (ACTUAL): April 1, 2008

Study Registration Dates

• First Submitted: March 13, 2007
• First Submitted That Met QC Criteria: March 19, 2009
• First Posted (ESTIMATE): March 20, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 20, 2009
• Last Update Submitted That Met QC Criteria: March 19, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: LA05