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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2014