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Completed

NCT Number: NCT00869284

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

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

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emmanuel Gyan

Tours, 37000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CEEP regimen

Drug

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

Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)

Procedure

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 outcomes

  1. Complete response

    Time frame: end of treatment

Secondary outcomes

  1. overall survival disease free survival

    Time frame: 10 years after treatment

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Collaborators

  • Amgen

Registry information

Official study title

Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas

Acronym: 073

Important dates

Study start
1994
Primary completion
1999
Study completion
2009
First posted
Mar 25, 2009
Registry last updated
Mar 25, 2009

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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