Clinical trial NCT00696735: High-Dose Therapy Treatment in Patients With Follicular Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Follicular Lymphoma
Keywords: Phase III study patients with follicular lymphoma
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
First posted: 2008-06-13
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: event free survival
timeFrame: from diagnosis to first event
Secondary outcomes:
measure: safety
timeFrame: from diagnosis to death
Other outcomes:
Locations:
city: Tours
country: France
facility: Emmanuel GYAN
city: Tours
country: France
facility: Philippe COLOMBAT
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Philippe COLOMBAT, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gyan E, Foussard C, Bertrand P, Michenet P, Le Gouill S, Berthou C, Maisonneuve H, Delwail V, Gressin R, Quittet P, Vilque JP, Desablens B, Jaubert J, Ramee JF, Arakelyan N, Thyss A, Molucon-Chabrot C, Delepine R, Milpied N, Colombat P, Deconinck E; Groupe Ouest-Est des Leucemies et des Autres Maladies du Sang (GOELAMS). High-dose therapy followed by autologous purged stem cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by the GOELAMS with final results after a median follow-up of 9 years. Blood. 2009 Jan 29;113(5):995-1001. doi: 10.1182/blood-2008-05-160200. Epub 2008 Oct 27.