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Completed

NCT Number: NCT00965289

High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma

A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.

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Key information

Conditions

B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital

Nantes, 44000, France

About this study

Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 to 60 y.o
  • Aggressive Large B-Cell Lymphoma (CD20+)
  • Ann Arbor stage III, IV
  • IH or high adjusted IPI
  • signed inform consent

Exclusion criteria

  • Age < 18 ou > 60 y.o
  • other type of lymphoma
  • serology VIH +
  • other neoplasms apart from basal cell carcinoma or situ carcinoma

Treatment and study plan

Rituximab

Drug

Rituximab infusion on day 1 dose: 375mg/m²

Other names: Mabthera®

Primary outcomes

  1. CR rate after 3 high dose chemotherapy courses

    Time frame: safety/efficacy of chemotherapy treatment

Secondary outcomes

  1. CR and PR rate at the end of the study treatment

    Time frame: safety/efficacy of treatment30 days after the end of post ASCT aplasia

  2. PFS,EFS and OS

    Time frame: safety/efficacy of study treatment

  3. Tolerance of Rituximab combined with chemotherapy

    Time frame: safety/efficacy of immunotherapy combined with chemotherapy treatment

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • French Innovative Leukemia Organisation
  • Hoffmann-La Roche

Registry information

Official study title

Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.

Important dates

Study start
2002
Primary completion
2003
Study completion
2009
First posted
Aug 25, 2009
Registry last updated
Aug 26, 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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