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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)

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ClinicalTrials.gov Identifier: NCT00869284
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : March 25, 2009
Sponsor:
Collaborator:
Amgen
Information provided by:
French Innovative Leukemia Organisation

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

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas
Study Start Date : October 1994
Actual Primary Completion Date : July 1999
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources


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.



Primary Outcome Measures :
  1. Complete response [ Time Frame: end of treatment ]

Secondary Outcome Measures :
  1. overall survival disease free survival [ Time Frame: 10 years after treatment ]


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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869284


Locations
France
Emmanuel Gyan
Tours, France, 37000
Sponsors and Collaborators
French Innovative Leukemia Organisation
Amgen
Investigators
Principal Investigator: Noël MILPIED, MDPD French Innovative Leukemia Organisation

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
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by French Innovative Leukemia Organisation:
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