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.
Looking for future studies?
Notify MeKey information
Conditions
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
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
Cyclophosphamide
DrugAutologous Stem Cell Transplantation
ProcedurePrimary outcomes
-
Event free survival.
Secondary outcomes
-
Complete response rate at the end of treatment.
-
Disease-free survival for complete responders.
-
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma
NCT00498043
Hemic and Lymphatic Diseases, Immune System Diseases
Dijon, France
View Trial DetailsR-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell Lymphoma
NCT00137995
Hemic and Lymphatic Diseases, Immune System Diseases
New York, United States
View Trial DetailsOfatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma
NCT01014208
Disease Attributes, Hemic and Lymphatic Diseases
Sacramento, California, United States
View Trial DetailsOfatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
NCT00622388
Hemic and Lymphatic Diseases, Immune System Diseases
London, United Kingdom
View Trial Details