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OpenTrials
Completed

NCT Number: NCT00169130

ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Service d'Hematologie, Mont-Godinne, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Doxorubicin

Drug

Cyclophosphamide

Drug

Autologous Stem Cell Transplantation

Procedure

Primary outcomes

  1. Event free survival.

Secondary outcomes

  1. Complete response rate at the end of treatment.

  2. Disease-free survival for complete responders.

  3. Overall survival.

Sponsors and collaborators

Lead sponsor

Lymphoma Study Association

Other

Collaborators

  • Fondation ARC

Registry information

Official study title

Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation 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

Important dates

Study start
1999
First posted
Sep 15, 2005
Registry last updated
Jul 13, 2007

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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