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ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

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

NCT00169130•Lymphoma Study Association

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (5)

Service d'Hematologie

Mont-Godinne, Belgium

Hôpital Henri Mondor

Créteil, France

Hôpital Saint Louis

Paris, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Centre Henri Becquerel

Rouen, France

Key Dates

Start Date

October 1, 1999

Last Updated

July 13, 2007

Enrollment

300

Estimated participants

Conditions

Lymphoma, Large-Cell, Diffuse

Interventions

doxorubicin

DRUG

cyclophosphamide

DRUG

Autologous stem cell transplantation

PROCEDURE

R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma

NCT00135499

Lymphoma, Large-Cell, Diffuse

View study

TERMINATEDPHASE2

Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) Subjects

NCT00498914

Lymphoma, Large-Cell, DiffuseLymphoma, B-Cell Refractory

View study

TERMINATED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma

Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) Subjects

PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma

Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL