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NCT Number: NCT00696735

High-Dose Therapy Treatment in Patients With Follicular Lymphoma

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emmanuel GYAN, Tours, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Procedure

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

Procedure

VCAP regimen 3 cycles , less than PR: 2-3 DHAP, stem cell collection, in vitro purging autologous stem cell transplantation with TBI and cyclophosphamide

Primary outcomes

  1. event free survival

    Time frame: from diagnosis to first event

Secondary outcomes

  1. safety

    Time frame: from diagnosis to death

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Registry information

Official study 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

Important dates

Study start
1994
Primary completion
2003
Study completion
2006
First posted
Jun 13, 2008
Registry last updated
Oct 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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