NCT00169130

Brief Summary

The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

July 13, 2007

Status Verified

July 1, 2007

First QC Date

September 12, 2005

Last Update Submit

July 12, 2007

Conditions

Lymphoma, Large-Cell, Diffuse

Keywords

lymphomaautologous stem cell transplantchemotherapyBCL2

Outcome Measures

Primary Outcomes (1)

  • Event free survival.

Secondary Outcomes (3)

  • Complete response rate at the end of treatment.

  • Disease-free survival for complete responders.

  • Overall survival.

Interventions

doxorubicinDRUG
cyclophosphamideDRUG
Autologous stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
  • Aged 18 to 60 years
  • Non previously treated
  • With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level
  • Negative HIV, HBV and HCV serologies (except vaccination)
  • With a minimum life expectancy of 3 months
  • Having previously signed a written informed consent

You may not qualify if:

  • Any history of treated or non-treated indolent lymphoma.
  • T-cell lymphoma.
  • Central nervous system or meningeal involvement by lymphoma.
  • Any Contra-indication to any drug contained in the chemotherapy regimens.
  • Poor renal function (creatinin level\>150µmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
  • Serious active disease (according to the investigator's decision).
  • Poor bone marrow reserve as defined by neutrophils \<1.5G/l or platelets\<100G/l, unless related to bone marrow infiltration.
  • Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
  • Childbearing woman.
  • Patients previously treated with an organ transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Service d'Hematologie

Mont-Godinne, Belgium

Location

Hôpital Henri Mondor

Créteil, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

Centre Henri Becquerel

Rouen, 76000, France

Location

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma

Interventions

DoxorubicinCyclophosphamide

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Pierre Morel, MD

    Centre Hospitalier Schaffner, Lens FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

October 1, 1999

Last Updated

July 13, 2007

Record last verified: 2007-07

Locations

FR(4)BE(1)