Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas (073)

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00869284
First received: March 23, 2009
Last updated: March 24, 2009
Last verified: March 2009
  Purpose

Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.


Condition Intervention Phase
Lymphoma
Drug: CEEP regimen
Procedure: Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Complete response [ Time Frame: end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival disease free survival [ Time Frame: 10 years after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: October 1994
Study Completion Date: February 2009
Primary Completion Date: July 1999 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CEEP regimen
    cyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals
    Procedure: Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)

    The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4.

    The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8.

Detailed Description:

High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged from 15 to 60 years
  • previously untreated
  • histologically proven aggressive NHL
  • high aa-IPI (equal to 3)
  • proper underlying organ function

Exclusion Criteria:

  • transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869284

Locations
France
Emmanuel Gyan
Tours, France, 37000
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Amgen
Investigators
Principal Investigator: Noël MILPIED, MDPD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

Additional Information:
No publications provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Noel MILPIED, Groupe Ouest Est des Leucémies et autres maladies du sang
ClinicalTrials.gov Identifier: NCT00869284     History of Changes
Other Study ID Numbers: GOELAMS 073, no other identification number
Study First Received: March 23, 2009
Last Updated: March 24, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
High-dose chemotherapy
aggressive NHL
high-risk
PBSC

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014