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High-Dose Therapy Treatment in Patients With Follicular Lymphoma
This study has been completed.
Sponsored by: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier: NCT00696735
  Purpose

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.


Condition Intervention Phase
Follicular Lymphoma
Procedure: chemotherapy
Procedure: high dose therapy and autologous stem cell transplantation
Phase III

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Prednisone Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Teniposide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • event free survival [ Time Frame: from diagnosis to first event ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety [ Time Frame: from diagnosis to death ] [ Designated as safety issue: Yes ]

Enrollment: 172
Study Start Date: June 1994
Study Completion Date: May 2006
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
standard chemotherapy arm, the CHVP (cyclophosphamide, low-dose doxorubicin, teniposide, and prednisone) regimen consisted of cyclophosphamide (600 mg/m2), doxorubicin (25 mg/m2), and teniposide (60 mg/m2), all administered intravenously 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.
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.
2: Experimental
VCAP (cyclophosphamide, high-dose doxorubicin, prednisone, and vincristine) regimen as a first-line therapy combining vindesine (3 mg/m2) on day 1, cyclophosphamide (1500 mg/m2) on day 2, doxorubicin (80 mg/m2) on day 2, and prednisolone (50 mg/m2) on days 1 to 5, every 3 weeks.19,31,32 Patients in CR, VGPR, or PR after the second or third VCAP cycle continued on to stem-cell harvesting and received, before transplantation, one course of IMVP16 (ifosfamide, methotrexate, and VP-16), which combined ifosfamide (1.5 g/m2) and VP16 (100 mg/m2) on days 1 through 3, and methotrexate (30 mg/m2) on days 1 and 10. Patients with less than PR after the VCAP cycles received, as salvage therapy, 2 to 3 courses of DHAP (dexamethasone, high-dose cytarabine, and cisplatin) combining cisplatine (100 mg/m2) on day 1, cytarabine (4 g/m2) on day 2, and dexamethasone (40 mg/m2) on days 1 through 4. If at least a PR was obtained after DHAP, stem cells were harvested or patients were considered as failures
Procedure: 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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696735

Locations
France
Philippe COLOMBAT
TOURS, France, 37000
Emmanuel GYAN
TOURS, France, 37000
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Investigators
Principal Investigator: Philippe COLOMBAT, MD PHD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

GOELAMS internet site  This link exits the ClinicalTrials.gov site

Responsible Party: GOELAMS ( GOELAMS 064 Trial )
Study ID Numbers: GOELAMS 064
Study First Received: June 11, 2008
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00696735  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
Phase III study patients with follicular lymphoma

Study placed in the following topic categories:
Interferon-alpha
Prednisone
Immunoproliferative Disorders
Interferons
Lymphoma, Follicular
Cyclophosphamide
Doxorubicin
Teniposide
Lymphatic Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Interferon Alfa-2a
Lymphoma
Interferon Alfa-2b
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009