High-Dose Therapy Treatment in Patients With Follicular Lymphoma

Follicular Lymphoma Clinical Trial

Official title:

Randomized Phase III Study Comparison Between Conventional Chemotherapy and High-Dose Therapy Followed by Autologous Purged Stem-Cell Transplantation in Patients With Follicular Lymphoma Stage III,IV First-Line Treatment for Patients Younger Than 60 Years Old With a High Tumor Burden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696735
• Other study ID #: GOELAMS 064
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2008
• Last updated: October 23, 2008
• Start date: June 1994
• Est. completion date: May 2006

Study information

• Verified date: September 2006
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: May 2006
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Procedure:
• chemotherapy
injection cyclophosphamide doxorubicin (25 mg/m2), and teniposide (60 mg/m2)(600 mg/m2)on day 1 and prednisone (40 mg/m2), administered orally on days 1 to 5.4,12 Treatment consisted of a 6-course induction phase administered monthly, followed, for responders and patients presenting a stable disease, by a maintenance phase that consisted of 1 cycle every 2 months for 1 year. Concomitant subcutaneous interferon alfa-2b was administered at 5 x 106 3 times a week for 18 months.
• high dose therapy and autologous stem cell transplantation
VCAP regimen 3 cycles , less than PR: 2-3 DHAP, stem cell collection, in vitro purging autologous stem cell transplantation with TBI and cyclophosphamide

Locations

Country	Name	City	State
France	Emmanuel GYAN	Tours
France	Philippe COLOMBAT	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	event free survival		from diagnosis to first event	Yes
Secondary	safety		from diagnosis to death	Yes