High-Dose Therapy Treatment in Patients With Follicular Lymphoma

Phase 3

Completed

• Conditions: Follicular Lymphoma

• Registration Number: NCT00696735
• Lead Sponsor: French Innovative Leukemia Organisation

Brief Summary

Follicular lymphomas are a subgroup of B-cell non-Hodgkin lymphomas, accounting for 15% to 30% of newly diagnosed lymphomas.1-3 Median survival varies from 5 to 10 years depending on the prognostic factors at diagnosis and response to first-line therapy.4-6 Whatever the treatment, no plateau appears on survival curves, and virtually all patients relapse; follicular lymphomas are ultimately progressive, and fatal.2,3,5 No reference first-line treatment is clearly defined. One of the most active therapies is still doxorubicin-based chemotherapy with or without interferon.7-9 New therapeutic approaches including purine analogs and anti-CD20 monoclonal antibody are promising and are progressively included in the management of these lymphomas.2,3,10-13 The role of high-dose therapy (HDT) as a salvage treatment for patients with relapsing follicular lymphoma is demonstrated by some authors; several reports have shown the superiority of HDT followed by autologous stem-cell transplantation, purged or unpurged, compared with conventional chemotherapy in terms of no relapse and overall survival.14-18 Only a few reports have been published showing HDT results as a first-line treatment for poor-risk patients with follicular lymphoma, and the results remain controversial.19-26 These data prompted the French Groupe Ouest-Est des Leucémies et Autres Maladies du Sang (GOELAMS) to conduct a prospective randomized trial using patients with newly diagnosed follicular lymphoma with a high tumor burden. A combined doxorubicin-based chemotherapy associated with interferon was compared to front-line HDT followed by purged autologous stem-cell transplantation.

Detailed Description

Age 8-60 years old follicular lymphoma Not previously treated Stage II bulky, III or IV An Arbor classification high tumor burden

Study Timeline

• Study Start: 1994-06
• Primary Completion: 2003-05
• Study Completion: 2006-05
• Status Verified: 2006-09
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Last Update Submitted: 2008-10-23
• Last Update Posted: 2008-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Age 18-60 years old
• Follicular Lymphoma B, C or D (Working Formulation)
• No previous treatment
• Seronegativity HIV
• ECOG performance status less than or 2
• eligible for autologous stem-cell transplantation
• Stage II , III or IV Ann Arbor Classification
• criterias of high tumor burden
• Patient's written informed consent

Exclusion Criteria

• Age less than 18 years old or more than 60 years old
• Other type of lymphoma
• Stage less than 3 or III-IV (faible masse)
• Seropositivity HIV
• Patients with a history of another malignancy except basal cell skin cancer or in situ uterus cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
event free survival	from diagnosis to first event

Secondary Outcome Measures

Name	Time	Method
safety	from diagnosis to death

Trial Locations

Locations (2)

Emmanuel GYAN; 🇫🇷 Tours, France

Philippe COLOMBAT; 🇫🇷 Tours, France