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

NCT00866203 | Completed Phase 3

• 1 other identifier: LA05
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Grade Lymphomas

Outcome Measures

Primary Outcomes (4)

• remission duration

  end of treatment

• overall survival

  study end

• event-free survival

  study end

• freedom-from progression

  study end

Secondary Outcomes (1)

• feasibility and toxicity

  end of treatment

Study Arms (2)

HDS

EXPERIMENTAL

modified high dose sequential therapy

Drug: HDS vs ProMECE/CytaBOM

ProMECE/CytaBOM

ACTIVE COMPARATOR

four additional courses of standard ProMECE/CytaBOM

Drug: HDS vs ProMECE/CytaBOM

Interventions

HDS vs ProMECE/CytaBOM DRUG

HDS; ProMECE/CytaBOM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Studio Linfomi: lead

Study Sites (1)

GISL Trial Office

Modena, 41100, Italy

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nicola Di Renzo, MD

  GISL

  PRINCIPAL INVESTIGATOR

• Massimo Federico, MD

  GISL

  STUDY CHAIR

• Maura Brugiatelli, MD

  GISL

  STUDY CHAIR

• Mario Petrini, MD

  GISL

  STUDY CHAIR

• Paolo G Gobbi, MD

  GISL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 20, 2009
• Study Start: October 1, 2000
• Study Completion: April 1, 2008
• Last Updated: March 20, 2009

Record last verified: 2009-03

Locations

IT (1)